Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-10 @ 2:30 PM
Study NCT ID:
NCT03285958
Status:
COMPLETED
Last Update Posted:
2021-10-04
First Post:
2017-09-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tracking Physical Activity for Chronic Pain Management Among Older Adults in Detroit
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mjanevic@umich.edu', 'phone': '734 647 3194', 'title': 'Dr. Mary Janevic', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'STEPS Intervention Group', 'description': 'Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period.\n\nSTEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'STEPS Control Group', 'description': 'Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'hospitalization', 'notes': 'Participant was hospitalized for pneumonia. Not related to research.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Pain Interference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STEPS Intervention Group', 'description': 'Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period.\n\nSTEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.'}, {'id': 'OG001', 'title': 'STEPS Control Group', 'description': 'Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.85', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '6.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, eight weeks', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Interference 4-item subscale, where a higher score indicates more pain interference. Items ask how much pain in the last 7 days has interfered with daily activities such as household chores and social activities (1=not at all to 5=very much). Raw scores are converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation). The possible range is 42 to 76, with a higher score representing worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This is from the analytic sample that had both baseline and follow-up data on this measure. Change score is the follow-up minus baseline score, such that a greater, negative change value is a better outcome.'}, {'type': 'PRIMARY', 'title': 'Adherence to Step Count Reporting - SMS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'person-days', 'counts': [{'value': '378', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'STEPS Intervention Group', 'description': 'This analysis was only conducted on the Intervention group, who participated in 6 weeks of tracking and reporting step counts.'}], 'classes': [{'categories': [{'measurements': [{'value': '299', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Two weeks', 'description': 'Proportion of days that step count was successfully provided/possible reporting days for SMS', 'unitOfMeasure': 'person-days', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'person-days', 'denomUnitsSelected': 'person-days', 'populationDescription': 'Intervention group participants with baseline and follow-up data. Excludes one case that did not have a texting plan on her phone. Result represents number of adherent person-days out of all possible person-days for SMS.'}, {'type': 'PRIMARY', 'title': 'Adherence to Step Count Reporting - IVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'person-days', 'counts': [{'value': '378', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'STEPS Intervention Group', 'description': 'This analysis was only conducted on the Intervention group, who participated in 6 weeks of tracking and reporting step counts.'}], 'classes': [{'categories': [{'measurements': [{'value': '257', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'two weeks', 'description': 'Proportion of days that step count was successfully provided/possible reporting days for IVR.', 'unitOfMeasure': 'person-days', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'person-days', 'denomUnitsSelected': 'person-days', 'populationDescription': 'Intervention group participants with baseline and follow-up data. Excludes one case who did not receive IVR calls on schedule due to system error. Result represents number of adherent person-days out of all possible person-days for IVR.'}, {'type': 'PRIMARY', 'title': 'Adherence to Step Count Reporting - Sync', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}, {'units': 'person-days', 'counts': [{'value': '392', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'STEPS Intervention Group', 'description': 'This analysis was only conducted on the Intervention group, who participated in 6 weeks of tracking and reporting step counts.'}], 'classes': [{'categories': [{'measurements': [{'value': '267', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'two weeks', 'description': 'Proportion of days that step count was successfully provided/possible reporting days for syncing with app', 'unitOfMeasure': 'person-days', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'person-days', 'denomUnitsSelected': 'person-days', 'populationDescription': 'Intervention group participants with baseline and follow-up data. Result represents number of adherent person-days out of all possible person-days for sync.'}, {'type': 'SECONDARY', 'title': 'Change in Physical Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STEPS Intervention Group', 'description': 'Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period.\n\nSTEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.'}, {'id': 'OG001', 'title': 'STEPS Control Group', 'description': 'Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '-0.85', 'spread': '3.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, eight weeks', 'description': 'The Physical Functioning 4-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Adult Profile. Items ask how much difficulty participant has in doing daily activities such as household chores, using stairs, and walking 15 minutes (1=without any difficulty to 5=unable to do); raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 23 to 57, with a higher score representing worse outcome.', 'unitOfMeasure': 'units on a scale (T-score)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had data on both baseline and follow-up measure. Change score is the follow-up minus baseline score, such that a greater, negative change value is a better outcome.'}, {'type': 'SECONDARY', 'title': 'Change in Social Participation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STEPS Intervention Group', 'description': 'Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period.\n\nSTEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.'}, {'id': 'OG001', 'title': 'STEPS Control Group', 'description': 'Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.28', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '8.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, eight weeks', 'description': 'Ability to Participate in Social Roles and Activities, a 4-item subscale from PROMIS-20 rating the amount of trouble (1=not at all to 5=very much) in participating in social roles such as family activities, leisure activities, and work. Raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 29 to 64, with a higher score representing worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had data on both baseline and follow-up measure. Change score is the follow-up minus baseline score, such that a greater, negative change value (or smaller positive value) is a better outcome.'}, {'type': 'SECONDARY', 'title': 'Validity of Manually-reported Step Count Data - SMS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'person-days', 'counts': [{'value': '256', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'STEPS Intervention Group', 'description': 'This analysis was only conducted on the Intervention group, who participated in 6 weeks of tracking and reporting step counts.'}], 'classes': [{'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Two weeks', 'description': 'Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other', 'unitOfMeasure': 'person-days', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'person-days', 'denomUnitsSelected': 'person-days', 'populationDescription': 'Result is number of person- days with valid data reported that were within 50 steps of sync value.'}, {'type': 'SECONDARY', 'title': 'Validity of Manually Reported Step Count Data - IVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'person-days', 'counts': [{'value': '215', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'STEPS Intervention Group', 'description': 'This analysis was only conducted on the Intervention group, who participated in 6 weeks of tracking and reporting step counts.'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Two weeks', 'description': 'Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other', 'unitOfMeasure': 'person-days', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'person-days', 'denomUnitsSelected': 'person-days', 'populationDescription': 'Result is number of person- days with valid data reported that were within 50 steps of sync value.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'STEPS Intervention Group', 'description': 'Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period.\n\nSTEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.'}, {'id': 'FG001', 'title': 'STEPS Control Group', 'description': 'Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Not able to attend required orientation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'No significant pre-assignment events.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'STEPS Intervention Group', 'description': 'Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period.\n\nSTEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.'}, {'id': 'BG001', 'title': 'STEPS Control Group', 'description': 'Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.3', 'spread': '7.1', 'groupId': 'BG000'}, {'value': '69.3', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '70.4', 'spread': '6.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pain intensity in last week', 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '5.4', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '5.2', 'spread': '1.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Pain intensity rated on 1 to 10 scale, where 1=no pain and 10=worst imaginable pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PROMIS 4-item pain interference T-score', 'classes': [{'categories': [{'measurements': [{'value': '58.7', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '57.0', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '58.0', 'spread': '7.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Items ask how much pain in the last 7 days has interfered with daily activities such as household chores and social activities (1=not at all to 5=very much). Converted to population-normed T-score (population mean of 50).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PROMIS 4-item physical function difficulty T-score', 'classes': [{'categories': [{'measurements': [{'value': '33.2', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '31.9', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '33.0', 'spread': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Items ask how much difficulty participant has in doing daily activities such as household chores, using stairs, and walking 15 minutes (1=without any difficulty to 5=unable to do). Converted to population-normed T-score (population mean of 50).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PROMIS 4-item social partcipation T-score', 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'spread': '7.3', 'groupId': 'BG000'}, {'value': '37.0', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '37.6', 'spread': '6.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Items assess difficulty participating in family activities, leisure activities, and work 1=not at all to 5=very much). Converted to population-normed T-score (population mean of 50).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Note: This is the analytic sample (i.e., participants with baseline and 8-week follow-up data, representing 51 of 57 randomized.)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-19', 'size': 145978, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-31T10:50', 'hasProtocol': True}, {'date': '2018-06-19', 'size': 113979, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-08-31T10:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-02', 'studyFirstSubmitDate': '2017-09-14', 'resultsFirstSubmitDate': '2021-09-02', 'studyFirstSubmitQcDate': '2017-09-14', 'lastUpdatePostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-02', 'studyFirstPostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Interference', 'timeFrame': 'Baseline, eight weeks', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Interference 4-item subscale, where a higher score indicates more pain interference. Items ask how much pain in the last 7 days has interfered with daily activities such as household chores and social activities (1=not at all to 5=very much). Raw scores are converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation). The possible range is 42 to 76, with a higher score representing worse outcome.'}, {'measure': 'Adherence to Step Count Reporting - SMS', 'timeFrame': 'Two weeks', 'description': 'Proportion of days that step count was successfully provided/possible reporting days for SMS'}, {'measure': 'Adherence to Step Count Reporting - IVR', 'timeFrame': 'two weeks', 'description': 'Proportion of days that step count was successfully provided/possible reporting days for IVR.'}, {'measure': 'Adherence to Step Count Reporting - Sync', 'timeFrame': 'two weeks', 'description': 'Proportion of days that step count was successfully provided/possible reporting days for syncing with app'}], 'secondaryOutcomes': [{'measure': 'Change in Physical Functioning', 'timeFrame': 'Baseline, eight weeks', 'description': 'The Physical Functioning 4-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Adult Profile. Items ask how much difficulty participant has in doing daily activities such as household chores, using stairs, and walking 15 minutes (1=without any difficulty to 5=unable to do); raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 23 to 57, with a higher score representing worse outcome.'}, {'measure': 'Change in Social Participation', 'timeFrame': 'Baseline, eight weeks', 'description': 'Ability to Participate in Social Roles and Activities, a 4-item subscale from PROMIS-20 rating the amount of trouble (1=not at all to 5=very much) in participating in social roles such as family activities, leisure activities, and work. Raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 29 to 64, with a higher score representing worse outcome.'}, {'measure': 'Validity of Manually-reported Step Count Data - SMS', 'timeFrame': 'Two weeks', 'description': 'Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other'}, {'measure': 'Validity of Manually Reported Step Count Data - IVR', 'timeFrame': 'Two weeks', 'description': 'Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'Wearable, commercially-available physical activity monitors are being increasingly incorporated into chronic pain self-management interventions as a tool to help patients set goals and to tailor intervention content based on patient progress. Yet older adults from resource-challenged communities may face significant barriers to using these monitors and reporting activity data. Our pilot study will focus on wearable monitor use among older adults in Detroit with chronic musculoskeletal pain, testing the feasibility and validity of various technology-based strategies for reporting daily step count data. The study will also assess whether six weeks of monitor use is associated with improvements in functioning, relative to a control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 60 years\n* Ambulatory with or without assistive device\n* Community living\n* Have a SMS-capable cell phone\n* Internet access (via smartphone, in-home or elsewhere);\n* Self-reported chronic musculoskeletal pain (pain in muscles or joints for \\> 3 months)\n* \\>4 (0-10 scale) average pain level over last week\n* \\>1 day/previous 30 when pain made it difficult to do usual activities\n* Ability to travel to study location in Detroit for a one-time session\n\nExclusion criteria:\n\n* Serious acute illness or hospitalization in last month\n* Planned surgery in next month\n* Severe cognitive impairment'}, 'identificationModule': {'nctId': 'NCT03285958', 'briefTitle': 'Tracking Physical Activity for Chronic Pain Management Among Older Adults in Detroit', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Promoting Physical Activity for Chronic Pain Management Among Older Adults in Detroit: Comparing Technology-Based Strategies', 'orgStudyIdInfo': {'id': 'HUM00133021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STEPS Intervention Group', 'description': 'Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period.', 'interventionNames': ['Behavioral: STEPS Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'STEPS Control Group', 'description': 'Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.'}], 'interventions': [{'name': 'STEPS Intervention', 'type': 'BEHAVIORAL', 'description': 'Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.', 'armGroupLabels': ['STEPS Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Mary Janevic', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan School of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Research Scientist', 'investigatorFullName': 'Mary Janevic', 'investigatorAffiliation': 'University of Michigan'}}}}