Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-03-04 @ 4:28 AM
Study NCT ID:
NCT02478359
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2015-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Walk On! Physical Activity Coaching
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'huong.q2.nguyen@kp.org', 'phone': '626-564-3935', 'title': 'Huong Q2 Nguyen, Research Scientist', 'organization': 'Kaiser Permanente'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'It is important to note the low uptake/participation in the Walk On! intervention and its effects on the primary, intention to treat analyses, as well, the sub-optimal baseline and follow-up response rates to the patient-reported outcomes.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Adverse event monitoring focused on passive monitoring via the EMR, components of the primary composite outcome (all cause hospitalizations, observation stays, emergency department visits, and death) for all randomized patients. Only deaths are reported here as anticipated serious adverse events, not related to study procedures. All-cause acute care utilization events were also considered anticipated serious adverse events, not related to study procedures.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan', 'otherNumAtRisk': 1349, 'deathsNumAtRisk': 1349, 'otherNumAffected': 963, 'seriousNumAtRisk': 1349, 'deathsNumAffected': 117, 'seriousNumAffected': 499}, {'id': 'EG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.', 'otherNumAtRisk': 1358, 'deathsNumAtRisk': 1358, 'otherNumAffected': 997, 'seriousNumAtRisk': 1358, 'deathsNumAffected': 117, 'seriousNumAffected': 502}], 'otherEvents': [{'term': 'Observational Stays', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1349, 'numEvents': 269, 'numAffected': 269}, {'groupId': 'EG001', 'numAtRisk': 1358, 'numEvents': 295, 'numAffected': 295}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency Department Visits', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1349, 'numEvents': 694, 'numAffected': 694}, {'groupId': 'EG001', 'numAtRisk': 1358, 'numEvents': 702, 'numAffected': 702}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'All-cause hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1349, 'numEvents': 499, 'numAffected': 499}, {'groupId': 'EG001', 'numAtRisk': 1358, 'numEvents': 502, 'numAffected': 502}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With All-cause Hospitalizations, Emergency Department (ED) Visits, Observation Stays, and Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'OG000'}, {'value': '1358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '864', 'groupId': 'OG000'}, {'value': '883', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.28', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months following randomization', 'description': 'Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Deaths Among Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'OG000'}, {'value': '1358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.36', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months following randomization', 'description': 'Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-cause Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'OG000'}, {'value': '1358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '499', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.53', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.24', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months following randomization', 'description': 'Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-cause Emergency Department Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'OG000'}, {'value': '1358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '694', 'groupId': 'OG000'}, {'value': '702', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.73', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.20', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months following randomization', 'description': 'Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-cause Observation Stays', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'OG000'}, {'value': '1358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.37', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months following randomization', 'description': 'Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'OG000'}, {'value': '1358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '398', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.31', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months following randomization', 'description': 'Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With COPD Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'OG000'}, {'value': '1358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '706', 'groupId': 'OG000'}, {'value': '689', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months following randomization', 'description': 'COPD exacerbations were ascertained via pharmacy records and utilization data. An outpatient COPD exacerbation will be defined as a care touch (clinic visit, phone, or secure message encounter) with a diagnosis of COPD accompanied by a prescription of either an oral steroid or an antibiotic within 2 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'COPD Assessment Test, CAT - 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '20.5', 'spread': '8.47', 'groupId': 'OG000'}, {'value': '18.0', 'spread': '7.28', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '19.9', 'spread': '8.03', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '7.48', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 months from baseline', 'categories': [{'measurements': [{'value': '-0.56', 'spread': '6.46', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '6.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The reported mean change between the baseline and 12 Months scores for the Chronic Obstructive Pulmonary Disease Assessment Test (CAT). Score range is 0-40. A negative change score indicates fewer symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As treated population who completed the survey'}, {'type': 'SECONDARY', 'title': 'Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'OG000'}, {'value': '1358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'title': 'Inactive (0 mins/wk) Baseline', 'categories': [{'measurements': [{'value': '890', 'groupId': 'OG000'}, {'value': '911', 'groupId': 'OG001'}]}]}, {'title': 'Inactive (0 mins/wk) 12 Months', 'categories': [{'measurements': [{'value': '819', 'groupId': 'OG000'}, {'value': '808', 'groupId': 'OG001'}]}]}, {'title': 'Insufficiently Active (1-149 mins/wk) Baseline', 'categories': [{'measurements': [{'value': '262', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}]}, {'title': 'Insufficiently Active (1-149 mins/wk) 12 Months', 'categories': [{'measurements': [{'value': '243', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}]}, {'title': 'Active (>=150 mins/wk) Baseline', 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}]}, {'title': 'Active (>=150 mins/wk) 12 Months', 'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.34', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'adjusted p values', 'groupDescription': 'Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Patients were categorized as being: completely inactive (0 mins/week), insufficiently active (1-149 mins/week) or active, meeting national physical activity recommendations (\\>150 mins/week) of moderate to vigorous physical activity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Personal Health Questionnaire, PHQ8 - 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.6', 'spread': '6.00', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '4.22', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '6.3', 'spread': '5.40', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '4.10', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 months from Baseline', 'categories': [{'measurements': [{'value': '-0.30', 'spread': '4.66', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '3.90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.60', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The reported mean change between the baseline and 12 Months scores. Score range is 0-24. A negative change score indicates less depressive symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As treated population who completed the survey'}, {'type': 'SECONDARY', 'title': 'General Anxiety Disorder, GAD-7 - 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.2', 'spread': '5.81', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '4.05', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '4.5', 'spread': '5.08', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '4.25', 'groupId': 'OG001'}]}]}, {'title': 'Changes at 12 months from Baseline', 'categories': [{'measurements': [{'value': '-0.63', 'spread': '4.44', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '3.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.32', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The reported mean change between the baseline and 12 Months scores. Score range is 0-21. A negative change score indicates less anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As treated population who completed the survey'}, {'type': 'SECONDARY', 'title': 'PROMIS-10 HRQL , Physical Health - 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '39.8', 'spread': '8.62', 'groupId': 'OG000'}, {'value': '40.7', 'spread': '6.95', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '40.3', 'spread': '8.06', 'groupId': 'OG000'}, {'value': '41.7', 'spread': '7.18', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 months from Baseline', 'categories': [{'measurements': [{'value': '0.49', 'spread': '6.72', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '5.99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.47', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The reported mean change between the baseline and 12 Months T-scores. Score range is 16-68. A positive change score reflects better physical functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As treated population who completed the survey'}, {'type': 'SECONDARY', 'title': 'PROMIS-10 HRQL , Mental Health - 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '45.3', 'spread': '8.94', 'groupId': 'OG000'}, {'value': '47.7', 'spread': '8.80', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '46.0', 'spread': '8.65', 'groupId': 'OG000'}, {'value': '47.9', 'spread': '8.04', 'groupId': 'OG001'}]}]}, {'title': 'Changes at 12 months from Baseline', 'categories': [{'measurements': [{'value': '0.69', 'spread': '7.39', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '6.77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The reported mean change between the baseline and 12 Months T-scores. Score range is 21-68. A positive change score reflects better mental health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As treated population who completed the survey'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1127', 'groupId': 'OG000'}, {'value': '1186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.5', 'spread': '9.59', 'groupId': 'OG000'}, {'value': '70.1', 'spread': '9.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.87', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjusted P value', 'groupDescription': 'Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months following randomization', 'description': 'Average of all routine clinic blood pressure reading taken between 6 and 12-months post randomization. BP obtained with temperatures of \\>100F and those obtained in urgent care were excluded.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1127', 'groupId': 'OG000'}, {'value': '1186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '130.8', 'spread': '14.54', 'groupId': 'OG000'}, {'value': '130.7', 'spread': '14.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.70', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjusted P value', 'groupDescription': 'Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months following randomization', 'description': 'Average of all routine clinic blood pressure reading taken between 6 and 12-months post randomization. BP obtained with temperatures of \\>100F and those obtained in urgent care were excluded.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'HbA1c Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '383', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '1.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted P Values'}], 'paramType': 'MEAN', 'timeFrame': '12 months following randomization', 'description': 'HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization', 'unitOfMeasure': 'percentage of glycosylated hemoglobin,', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'LDL Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '593', 'groupId': 'OG000'}, {'value': '647', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.0', 'spread': '36.96', 'groupId': 'OG000'}, {'value': '86.6', 'spread': '32.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjusted P Values', 'groupDescription': 'Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months following randomization', 'description': 'Cholesterol levels were obtained from values closest to the 12 months post randomization', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'HDL Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '620', 'groupId': 'OG000'}, {'value': '671', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.3', 'spread': '18.28', 'groupId': 'OG000'}, {'value': '53.1', 'spread': '17.60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.82', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjusted P Values', 'groupDescription': 'Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months following randomization', 'description': 'Cholesterol levels were obtained from values closest to the 12 months post randomization', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Total Cholesterol Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '621', 'groupId': 'OG000'}, {'value': '673', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '168.8', 'spread': '44.91', 'groupId': 'OG000'}, {'value': '162.3', 'spread': '41.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjusted P values', 'groupDescription': 'Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months following randomization', 'description': 'Cholesterol levels were obtained from values closest to the 12 months post randomization', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Triglycerides Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '429', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '128.3', 'spread': '102.36', 'groupId': 'OG000'}, {'value': '119.0', 'spread': '65.60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.86', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjusted P values', 'groupDescription': 'Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months post randomization', 'description': 'Cholesterol levels were obtained from values closest to the 12 months post randomization', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1281', 'groupId': 'OG000'}, {'value': '1302', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.9', 'spread': '5.94', 'groupId': 'OG000'}, {'value': '27.07', 'spread': '5.90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.57', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months following randomization', 'description': 'Body mass index measurements were based on values closest to the 12 months post randomization', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With All-cause Hospitalization, Emergency Department (ED) Visits, Observation Stays and Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1310', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.\n\nPhysical Activity Coaching (Walk On!): The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '781', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.35', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 to 12 months following randomization', 'description': 'As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Deaths Among Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1310', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.\n\nPhysical Activity Coaching (Walk On!): The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.35', 'ciUpperLimit': '1.11', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 to 12 months following randomization', 'description': 'As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With All-cause Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1310', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.\n\nPhysical Activity Coaching (Walk On!): The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '433', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.10', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 to 12 months following randomization', 'description': 'As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With All-cause Emergency Department Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1310', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.\n\nPhysical Activity Coaching (Walk On!): The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '610', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.60', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.36', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 to 12 months following randomization', 'description': 'As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With All-cause Observation Stays', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1310', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.\n\nPhysical Activity Coaching (Walk On!): The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '230', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.63', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.28', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 to 12 months following randomization', 'description': 'As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1310', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.\n\nPhysical Activity Coaching (Walk On!): The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.80', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.35', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 to 12 months randomization', 'description': 'As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1127', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.5', 'spread': '9.59', 'groupId': 'OG000'}, {'value': '69.6', 'spread': '8.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjusted P value', 'groupDescription': 'Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6-12 months following randomization', 'description': 'Average of all routine clinic blood pressure reading taken between 6 and 12-months post randomization. BP obtained with temperatures of \\>100F and those obtained in urgent care were excluded.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated Walk On population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1127', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '130.8', 'spread': '14.54', 'groupId': 'OG000'}, {'value': '128.8', 'spread': '13.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjusted P value', 'groupDescription': 'Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6-12 months following randomization', 'description': 'Average of all routine clinic blood pressure reading taken between 6 and 12-months post randomization. BP obtained with temperatures of \\>100F and those obtained in urgent care were excluded.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated Walk On population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'HbA1c Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '1.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.67', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjusted P value', 'groupDescription': 'Covariates included in the as-treated adjusted linear regression analyses were FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated Walk On population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'LDL Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '593', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.0', 'spread': '36.96', 'groupId': 'OG000'}, {'value': '85.8', 'spread': '29.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjusted P value', 'groupDescription': 'Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Cholesterol levels were obtained from values closest to the 12 months post randomization', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated Walk On population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'HDL Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '620', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.3', 'spread': '18.28', 'groupId': 'OG000'}, {'value': '52.8', 'spread': '16.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.34', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjusted P value', 'groupDescription': 'Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Cholesterol levels were obtained from values closest to the 12 months post randomization', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated Walk On population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Cholesterol Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '621', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '168.8', 'spread': '44.91', 'groupId': 'OG000'}, {'value': '161.4', 'spread': '38.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjusted P value', 'groupDescription': 'Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Cholesterol levels were obtained from values closest to the 12 months post randomization', 'unitOfMeasure': 'md/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated Walk On population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Triglycerides Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'OG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'classes': [{'categories': [{'measurements': [{'value': '128.03', 'spread': '102.36', 'groupId': 'OG000'}, {'value': '116.2', 'spread': '61.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.83', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjusted P value', 'groupDescription': 'Covariated included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Cholesterol levels were obtained from values closest to the 12 months post randomization', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated Walk On population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'FG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1349'}, {'groupId': 'FG001', 'numSubjects': '1358'}]}, {'type': 'Intention-to-treat Population Month 12', 'achievements': [{'comment': 'Disenrolled from health plan: 106', 'groupId': 'FG000', 'numSubjects': '1243'}, {'comment': 'Disenrolled from health plan: 65', 'groupId': 'FG001', 'numSubjects': '1293'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1243'}, {'groupId': 'FG001', 'numSubjects': '1293'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '65'}]}], 'dropWithdraws': [{'type': 'Disenrolled from health plan', 'reasons': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '65'}]}]}], 'recruitmentDetails': 'Eligible patients were randomly assigned 1:1 to Walk On! or Standard Care arm at the point of identification of eligibility based on EMR data.', 'preAssignmentDetails': 'Patients assigned to the Walk On! arm were all approached to participate in and consent to the intervention activities.\n\nOnly a randomly selected subgroup within Standard Care (n=537) were approached to complete surveys for comparison with the Walk On! group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'id': 'BG001', 'title': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '300', 'groupId': 'BG000'}, {'value': '305', 'groupId': 'BG001'}, {'value': '605', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1049', 'groupId': 'BG000'}, {'value': '1053', 'groupId': 'BG001'}, {'value': '2102', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '72.4', 'spread': '10.14', 'groupId': 'BG000'}, {'value': '72.4', 'spread': '10.24', 'groupId': 'BG001'}, {'value': '72.4', 'spread': '10.19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '739', 'groupId': 'BG000'}, {'value': '716', 'groupId': 'BG001'}, {'value': '1455', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '610', 'groupId': 'BG000'}, {'value': '642', 'groupId': 'BG001'}, {'value': '1252', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '375', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1021', 'groupId': 'BG000'}, {'value': '989', 'groupId': 'BG001'}, {'value': '2010', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smoking Status', 'classes': [{'title': 'Never', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}]}]}, {'title': 'Former', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '933', 'groupId': 'BG000'}, {'value': '935', 'groupId': 'BG001'}, {'value': '1868', 'groupId': 'BG002'}]}]}, {'title': 'Current', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '243', 'groupId': 'BG000'}, {'value': '238', 'groupId': 'BG001'}, {'value': '481', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'spread': '6', 'groupId': 'BG000'}, {'value': '27.1', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '27.1', 'spread': '5.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pulmonary Rehabilitation (up to past 3 years)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Spirometry - FEV1 % Predicted', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '996', 'groupId': 'BG000'}, {'value': '1040', 'groupId': 'BG001'}, {'value': '2036', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60', 'spread': '21.9', 'groupId': 'BG000'}, {'value': '62.1', 'spread': '23.1', 'groupId': 'BG001'}, {'value': '61.0', 'spread': '22.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline values were not available on EMR for all participants.'}, {'title': 'Spirometry - FEV1/FVC ratio', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '996', 'groupId': 'BG000'}, {'value': '1040', 'groupId': 'BG001'}, {'value': '2036', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54.8', 'spread': '14.7', 'groupId': 'BG000'}, {'value': '55.4', 'spread': '13.9', 'groupId': 'BG001'}, {'value': '55.1', 'spread': '14.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Ratio (X100)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline values were not available on EMR for all participants.'}, {'title': 'Charlson Comorbidity Index score', 'classes': [{'title': 'Score 0-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '506', 'groupId': 'BG000'}, {'value': '516', 'groupId': 'BG001'}, {'value': '1022', 'groupId': 'BG002'}]}]}, {'title': 'Score 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '231', 'groupId': 'BG001'}, {'value': '441', 'groupId': 'BG002'}]}]}, {'title': 'Score 4-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '348', 'groupId': 'BG000'}, {'value': '332', 'groupId': 'BG001'}, {'value': '680', 'groupId': 'BG002'}]}]}, {'title': 'Score 6+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '285', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '564', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The total score in the CCI is derived by summing the assigned weights of all comorbid conditions presented by the client. Higher scores indicate a more severe condition and consequently, a worse prognosis', 'unitOfMeasure': 'Participants'}, {'title': 'Comorbidity', 'classes': [{'title': 'Heart Failture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '398', 'groupId': 'BG000'}, {'value': '407', 'groupId': 'BG001'}, {'value': '805', 'groupId': 'BG002'}]}]}, {'title': 'Pulmonary Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}]}, {'title': 'Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '456', 'groupId': 'BG000'}, {'value': '417', 'groupId': 'BG001'}, {'value': '873', 'groupId': 'BG002'}]}]}, {'title': 'Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '361', 'groupId': 'BG000'}, {'value': '380', 'groupId': 'BG001'}, {'value': '741', 'groupId': 'BG002'}]}]}, {'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '383', 'groupId': 'BG000'}, {'value': '359', 'groupId': 'BG001'}, {'value': '742', 'groupId': 'BG002'}]}]}, {'title': 'Chronic Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '273', 'groupId': 'BG000'}, {'value': '272', 'groupId': 'BG001'}, {'value': '545', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Medication', 'classes': [{'title': 'Long-lasting beta-agonists (LABA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '846', 'groupId': 'BG000'}, {'value': '800', 'groupId': 'BG001'}, {'value': '1646', 'groupId': 'BG002'}]}]}, {'title': 'Long-lasting anticholinergic (LAMA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '702', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '1422', 'groupId': 'BG002'}]}]}, {'title': 'Long-term systemic corticosteroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}]}]}, {'title': 'Oxygen-use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '550', 'groupId': 'BG000'}, {'value': '509', 'groupId': 'BG001'}, {'value': '1059', 'groupId': 'BG002'}]}]}, {'title': 'Inhaled corticosteroids (ICS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1094', 'groupId': 'BG000'}, {'value': '1053', 'groupId': 'BG001'}, {'value': '2147', 'groupId': 'BG002'}]}]}, {'title': 'LAMA & ICS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '631', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1244', 'groupId': 'BG002'}]}]}, {'title': 'LABA & ICS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '844', 'groupId': 'BG000'}, {'value': '797', 'groupId': 'BG001'}, {'value': '1641', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'All Cause Acute Care Utilization in the 12-months Prior to Randomization', 'classes': [{'title': 'Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '735', 'groupId': 'BG000'}, {'value': '702', 'groupId': 'BG001'}, {'value': '1437', 'groupId': 'BG002'}]}]}, {'title': 'Observation stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '394', 'groupId': 'BG000'}, {'value': '392', 'groupId': 'BG001'}, {'value': '786', 'groupId': 'BG002'}]}]}, {'title': 'Emergency department visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1050', 'groupId': 'BG000'}, {'value': '1039', 'groupId': 'BG001'}, {'value': '2089', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'COPD-Related Acute Care Utilization in the 12-months Prior to Randomization', 'classes': [{'title': 'Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '568', 'groupId': 'BG000'}, {'value': '539', 'groupId': 'BG001'}, {'value': '1107', 'groupId': 'BG002'}]}]}, {'title': 'Observation Stays', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '243', 'groupId': 'BG000'}, {'value': '237', 'groupId': 'BG001'}, {'value': '480', 'groupId': 'BG002'}]}]}, {'title': 'Emergency department visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '766', 'groupId': 'BG000'}, {'value': '765', 'groupId': 'BG001'}, {'value': '1531', 'groupId': 'BG002'}]}]}, {'title': 'Outpatient treated COPD exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1358', 'groupId': 'BG001'}, {'value': '2707', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '966', 'groupId': 'BG000'}, {'value': '936', 'groupId': 'BG001'}, {'value': '1902', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population included all participants randomized into the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-01', 'size': 1685391, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-21T15:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2707}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-07', 'studyFirstSubmitDate': '2015-06-03', 'resultsFirstSubmitDate': '2019-03-05', 'studyFirstSubmitQcDate': '2015-06-18', 'lastUpdatePostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-07', 'studyFirstPostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With All-cause Hospitalization, Emergency Department (ED) Visits, Observation Stays and Deaths', 'timeFrame': '2 to 12 months following randomization', 'description': 'As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.'}, {'measure': 'Number of Deaths Among Participants', 'timeFrame': '2 to 12 months following randomization', 'description': 'As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.'}, {'measure': 'Number of Participants With All-cause Hospitalizations', 'timeFrame': '2 to 12 months following randomization', 'description': 'As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.'}, {'measure': 'Number of Participants With All-cause Emergency Department Visits', 'timeFrame': '2 to 12 months following randomization', 'description': 'As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.'}, {'measure': 'Number of Participants With All-cause Observation Stays', 'timeFrame': '2 to 12 months following randomization', 'description': 'As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.'}, {'measure': 'Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays', 'timeFrame': '2 to 12 months randomization', 'description': 'As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': '6-12 months following randomization', 'description': 'Average of all routine clinic blood pressure reading taken between 6 and 12-months post randomization. BP obtained with temperatures of \\>100F and those obtained in urgent care were excluded.'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': '6-12 months following randomization', 'description': 'Average of all routine clinic blood pressure reading taken between 6 and 12-months post randomization. BP obtained with temperatures of \\>100F and those obtained in urgent care were excluded.'}, {'measure': 'HbA1c Levels', 'timeFrame': '12 months', 'description': 'HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization'}, {'measure': 'LDL Levels', 'timeFrame': '12 months', 'description': 'Cholesterol levels were obtained from values closest to the 12 months post randomization'}, {'measure': 'HDL Levels', 'timeFrame': '12 months', 'description': 'Cholesterol levels were obtained from values closest to the 12 months post randomization'}, {'measure': 'Total Cholesterol Levels', 'timeFrame': '12 months', 'description': 'Cholesterol levels were obtained from values closest to the 12 months post randomization'}, {'measure': 'Triglycerides Levels', 'timeFrame': '12 months', 'description': 'Cholesterol levels were obtained from values closest to the 12 months post randomization'}], 'primaryOutcomes': [{'measure': 'Number of Participants With All-cause Hospitalizations, Emergency Department (ED) Visits, Observation Stays, and Deaths', 'timeFrame': '12 months following randomization', 'description': 'Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site'}], 'secondaryOutcomes': [{'measure': 'Number of Deaths Among Participants', 'timeFrame': '12 months following randomization', 'description': 'Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site'}, {'measure': 'Number of Participants With All-cause Hospitalizations', 'timeFrame': '12 months following randomization', 'description': 'Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site'}, {'measure': 'Number of Participants With All-cause Emergency Department Visits', 'timeFrame': '12 months following randomization', 'description': 'Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site'}, {'measure': 'Number of Participants With All-cause Observation Stays', 'timeFrame': '12 months following randomization', 'description': 'Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site'}, {'measure': 'Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays', 'timeFrame': '12 months following randomization', 'description': 'Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site'}, {'measure': 'Number of Participants With COPD Exacerbation', 'timeFrame': '12 months following randomization', 'description': 'COPD exacerbations were ascertained via pharmacy records and utilization data. An outpatient COPD exacerbation will be defined as a care touch (clinic visit, phone, or secure message encounter) with a diagnosis of COPD accompanied by a prescription of either an oral steroid or an antibiotic within 2 days'}, {'measure': 'COPD Assessment Test, CAT - 12 Months', 'timeFrame': '12 months', 'description': 'The reported mean change between the baseline and 12 Months scores for the Chronic Obstructive Pulmonary Disease Assessment Test (CAT). Score range is 0-40. A negative change score indicates fewer symptoms.'}, {'measure': 'Physical Activity', 'timeFrame': '12 months', 'description': 'Patients were categorized as being: completely inactive (0 mins/week), insufficiently active (1-149 mins/week) or active, meeting national physical activity recommendations (\\>150 mins/week) of moderate to vigorous physical activity.'}, {'measure': 'Personal Health Questionnaire, PHQ8 - 12 Months', 'timeFrame': '12 months', 'description': 'The reported mean change between the baseline and 12 Months scores. Score range is 0-24. A negative change score indicates less depressive symptoms.'}, {'measure': 'General Anxiety Disorder, GAD-7 - 12 Months', 'timeFrame': '12 months', 'description': 'The reported mean change between the baseline and 12 Months scores. Score range is 0-21. A negative change score indicates less anxiety.'}, {'measure': 'PROMIS-10 HRQL , Physical Health - 12 Months', 'timeFrame': '12 months', 'description': 'The reported mean change between the baseline and 12 Months T-scores. Score range is 16-68. A positive change score reflects better physical functioning.'}, {'measure': 'PROMIS-10 HRQL , Mental Health - 12 Months', 'timeFrame': '12 months', 'description': 'The reported mean change between the baseline and 12 Months T-scores. Score range is 21-68. A positive change score reflects better mental health.'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': '12 months following randomization', 'description': 'Average of all routine clinic blood pressure reading taken between 6 and 12-months post randomization. BP obtained with temperatures of \\>100F and those obtained in urgent care were excluded.'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': '12 months following randomization', 'description': 'Average of all routine clinic blood pressure reading taken between 6 and 12-months post randomization. BP obtained with temperatures of \\>100F and those obtained in urgent care were excluded.'}, {'measure': 'HbA1c Levels', 'timeFrame': '12 months following randomization', 'description': 'HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization'}, {'measure': 'LDL Levels', 'timeFrame': '12 months following randomization', 'description': 'Cholesterol levels were obtained from values closest to the 12 months post randomization'}, {'measure': 'HDL Levels', 'timeFrame': '12 months following randomization', 'description': 'Cholesterol levels were obtained from values closest to the 12 months post randomization'}, {'measure': 'Total Cholesterol Levels', 'timeFrame': '12 months following randomization', 'description': 'Cholesterol levels were obtained from values closest to the 12 months post randomization'}, {'measure': 'Triglycerides Levels', 'timeFrame': '12 months post randomization', 'description': 'Cholesterol levels were obtained from values closest to the 12 months post randomization'}, {'measure': 'Body Mass Index', 'timeFrame': '12 months following randomization', 'description': 'Body mass index measurements were based on values closest to the 12 months post randomization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '26597414', 'type': 'BACKGROUND', 'citation': 'Nguyen HQ, Bailey A, Coleman KJ, Desai S, Fan VS, Gould MK, Maddock L, Miller K, Towner W, Xiang AH, Moy ML. Patient-centered physical activity coaching in COPD (Walk On!): A study protocol for a pragmatic randomized controlled trial. Contemp Clin Trials. 2016 Jan;46:18-29. doi: 10.1016/j.cct.2015.10.010. Epub 2015 Oct 24.'}, {'pmid': '30144938', 'type': 'BACKGROUND', 'citation': 'Nguyen HQ, Moy ML, Fan VS, Gould MK, Xiang A, Bailey A, Desai S, Coleman KJ. Applying the pragmatic-explanatory continuum indicator summary to the implementation of a physical activity coaching trial in chronic obstructive pulmonary disease. Nurs Outlook. 2018 Sep;66(5):455-463. doi: 10.1016/j.outlook.2018.05.005. Epub 2018 Jul 12.'}, {'pmid': '31418811', 'type': 'DERIVED', 'citation': 'Nguyen HQ, Moy ML, Liu IA, Fan VS, Gould MK, Desai SA, Towner WJ, Yuen G, Lee JS, Park SJ, Xiang AH. Effect of Physical Activity Coaching on Acute Care and Survival Among Patients With Chronic Obstructive Pulmonary Disease: A Pragmatic Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e199657. doi: 10.1001/jamanetworkopen.2019.9657.'}]}, 'descriptionModule': {'briefSummary': 'Chronic obstructive pulmonary disease (COPD) is the third leading cause of the death in the US. The personal, social and economic costs of the disease are tremendous, with annual expenditures of nearly $50 billion, mostly from hospitalizations for exacerbations of COPD and associated sequelae. For the vast majority of patients, despite optimal pharmacological therapy, living with COPD is characterized by unrelieved dyspnea, physical inactivity, deconditioning, and an insidious downward spiral of social isolation and depression that has a profound impact on the lives of patients and their caregivers. There is mounting evidence that physical inactivity is significantly associated with more frequent hospitalizations and increased mortality in COPD even after adjusting for disease severity.\n\nWhile practice guidelines recommend regular physical activity for all patients with COPD, health systems are challenged in operationalizing an effective and sustainable approach to assist patients in being physically active. The investigators propose a pragmatic randomized controlled trial to determine the effectiveness of a 12-month physical activity coaching intervention (Walk On!) compared to standard care for 1,650 COPD patients from a large integrated health care system.', 'detailedDescription': 'Physical inactivity is significantly associated with more frequent hospitalizations and increased mortality in COPD even after adjusting for disease severity. While practice guidelines recommend regular physical activity for all patients with COPD, health systems are challenged in operationalizing an effective and sustainable approach to assist patients in being physically active.\n\nA pragmatic randomized controlled trial design will be used to determine the effectiveness of a 12-month home and community-based physical activity coaching intervention (Walk On!) compared to standard care for 2,700 COPD patients from a large integrated health care system. Eligible patients with a COPD-related hospitalization, emergency department visit, or observational stay in the previous 12 months will be automatically identified from the electronic medical records (EMR) system and randomized to treatment arms. The Walk On! intervention includes collaborative monitoring of step counts, semi-automated step goal recommendations, individualized reinforcement from a physical activity coach, and peer/family support.\n\nThe primary composite outcome includes all-cause hospitalizations, emergency department visits, observational stays, and death in the 12 months following randomization. Secondary outcomes include COPD-related utilization, cardio-metabolic markers, physical activity, symptoms, and health-related quality of life. With the exception of patient reported outcomes, all utilization and clinical variables will be automatically captured from the EMR.\n\nIf successful, findings from this multi-stakeholder driven trial of a generalizable and scalable physical activity intervention model, carefully designed with sufficient flexibility, intensity, duration, and support for a large ethnically diverse sample could re-define the standard of care to effectively address physical inactivity in COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '41 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with any COPD-related hospitalization, emergency department visit or observational stay in the previous 12 months are eligible for the study. COPD-related encounters are defined according to the Centers for Medicare and Medicaid Services (CMS) and National Quality Forum (NQF) criteria for the Hospital Readmission Reduction Program. The following principal discharge diagnoses of COPD (ICD-9 codes: 491.21, 491.22, 491.8, 491.9, 492.8, 493.20, 493.21, 493.22, and 496) or respiratory failure (ICD-9 codes: 518.81, 518.82, 518.84, 799.1) with a secondary diagnosis of COPD exacerbation (ICD-9 codes: 491.21, 491.22, 493.21, 493.22) will be used\n* Age \\>40 years\n* On at least a bronchodilator or steroid inhaler prior to the encounter or if not on an inhaler, had a previous COPD diagnosis\n* Continuous health plan membership in the 12 months prior to the encounter\n\nExclusion Criteria:\n\n* FEV1/FVC ratio \\>0.70 at any point in the past year for those with spirometry data\n* Discharged to hospice, a skilled nursing facility, long term-care or another acute care hospital during the index admission\n* Level of function at admission or discharge during the index admission is bed bound\n* Has Alzheimers disease, dementia or metastatic cancer\n* Morbidly obese (BMI \\>40)\n* Completed pulmonary rehabilitation in the last 6 months\n* Deceased\n* Dis-enrolled from the health plan'}, 'identificationModule': {'nctId': 'NCT02478359', 'briefTitle': 'Walk On! Physical Activity Coaching', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Patient-Centered Physical Activity Coaching in COPD: A Pragmatic Trial', 'orgStudyIdInfo': {'id': 'KPSC IRB 12345'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan'}, {'type': 'EXPERIMENTAL', 'label': 'Physical Activity Coaching (Walk On!)', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.', 'interventionNames': ['Behavioral: Physical Activity Coaching (Walk On!)']}], 'interventions': [{'name': 'Physical Activity Coaching (Walk On!)', 'type': 'BEHAVIORAL', 'description': 'The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.', 'armGroupLabels': ['Physical Activity Coaching (Walk On!)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91101', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Southern California', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}], 'overallOfficials': [{'name': 'Huong Q Nguyen, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Scientist'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist', 'investigatorFullName': 'Huong Q2 Nguyen', 'investigatorAffiliation': 'Kaiser Permanente'}}}}