Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-27 @ 9:37 PM
Study NCT ID:
NCT04490395
Status:
COMPLETED
Last Update Posted:
2023-01-05
First Post:
2020-07-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Increasing Physical Activity in Older Adults With Osteoarthritis Pain: Examining a Brief Behavioral Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jennifer.plumb.vilardaga@duke.edu', 'phone': '919-668-6123', 'title': 'Jennifer Plumb Vilardaga, PhD', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Changes to measurement type during trial due to pandemic-related challenges (no objective daily steps data available despite intention to collect this data).'}}, 'adverseEventsModule': {'timeFrame': 'Approximately 6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Engage PA', 'description': 'Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment as Usual Plus Fitness Tracker', 'description': 'Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Enrolled in the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Engage PA', 'description': 'Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.'}, {'id': 'OG001', 'title': 'Treatment as Usual Plus Fitness Tracker', 'description': 'Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '9 months', 'description': 'How many participants, up to the expected 40 participants, enroll in the study within the study period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Expected participants.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Completed the Entire Program', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Engage PA', 'description': 'Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.'}, {'id': 'OG001', 'title': 'Treatment as Usual Plus Fitness Tracker', 'description': 'Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks', 'description': 'Participants who complete all assessments and required study sessions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Were Mostly or Very Satisfied With the Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Engage PA', 'description': 'Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post treatment (6 weeks)', 'description': 'Client Satisfaction Questionnaire asks 12 questions related to patient satisfaction on a Likert scale of 1 = very satisfied to 7 = very dissatisfied. There is one item assessing overall satisfaction with the intervention, and the percentage of participants responding to this item with "mostly" or "very" satisfied is reported below.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those receiving the active treatment (Engage PA group) were given this measure.'}, {'type': 'SECONDARY', 'title': 'Arthritis Pain (AIMS 2 Symptom Subscale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Engage PA', 'description': 'Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.'}, {'id': 'OG001', 'title': 'Treatment as Usual Plus Fitness Tracker', 'description': 'Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '13.72', 'spread': '3.80', 'groupId': 'OG000'}, {'value': '14.90', 'spread': '4.16', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment', 'categories': [{'measurements': [{'value': '11.78', 'spread': '3.69', 'groupId': 'OG000'}, {'value': '14.58', 'spread': '4.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.68', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '3.62', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-treatment (6 weeks)', 'description': 'The Arthritis Impact Measurement Scale (AIMS 2) measures arthritis pain related disability across areas of living both with a total score and on several subscales (i.e., pain severity, physical functioning/pain-related disability, psychological distress), where 1 indicates very good functioning, and 5 indicates very poor functioning. Symptom subscale includes items assessing pain severity, stiffness, and physical discomfort. Range is 5 to 25 where higher scores indicate worse functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected (n=1; TAU group) due to lost to follow up, data not analyzed (n=1; Engage PA group) due to assessment conducted out of window.'}, {'type': 'SECONDARY', 'title': 'Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Engage PA', 'description': 'Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.'}, {'id': 'OG001', 'title': 'Treatment as Usual Plus Fitness Tracker', 'description': 'Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.38', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '7.44', 'spread': '2.00', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment', 'categories': [{'measurements': [{'value': '6.64', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '7.51', 'spread': '2.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.056', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '1.33', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-treatment (6 weeks)', 'description': 'The Arthritis Impact Measurement Scale (AIMS 2) measures arthritis pain related disability across areas of living on several subscales (i.e., pain severity, physical functioning/pain-related disability, psychological distress), where 1 indicates very good functioning, and 5 indicates very poor functioning. Physical functioning subscale includes items assessing mobility level, walking and bending, self-care and household tasks. Range is 5-25 where higher scores indicate worse functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected (n=1; TAU group) due to lost to follow up, data not analyzed (n=1; Engage PA group) due to assessment conducted out of window.'}, {'type': 'SECONDARY', 'title': 'Psychological Distress (AIMS 2 Affect Subscale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Engage PA', 'description': 'Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.'}, {'id': 'OG001', 'title': 'Treatment as Usual Plus Fitness Tracker', 'description': 'Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.36', 'spread': '3.12', 'groupId': 'OG000'}, {'value': '10.37', 'spread': '2.85', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '10.59', 'spread': '4.15', 'groupId': 'OG000'}, {'value': '10.33', 'spread': '2.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.377', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-1.75', 'ciUpperLimit': '1.28', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-treatment (6 weeks)', 'description': 'The Arthritis Impact Measurement Scale (AIMS 2) measures arthritis pain related disability across areas of living on several subscales (i.e., pain severity, physical functioning/pain-related disability, psychological distress), where 1 indicates very good functioning, and 5 indicates very poor functioning. Psychological distress subscale includes items assessing mood and anxiety/tension. Range is 5-25 where higher scores indicate worse functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected (n=1; TAU group) due to lost to follow up, data not analyzed (n=1; Engage PA group) due to assessment conducted out of window.'}, {'type': 'SECONDARY', 'title': 'Daily Step Count in 7 Day Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Engage PA', 'description': 'Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.'}, {'id': 'OG001', 'title': 'Treatment as Usual Plus Fitness Tracker', 'description': 'Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '35712.55', 'spread': '27441.78', 'groupId': 'OG000'}, {'value': '28165.89', 'spread': '20916.05', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '38268.56', 'spread': '28154.68', 'groupId': 'OG000'}, {'value': '28154.67', 'spread': '29183.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.258', 'groupIds': ['OG000', 'OG001'], 'paramType': 'F test (1,15) df', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.381', 'groupDescription': 'Only 9 cases had any data available per group, and some had missing values and were not included in each analysis.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Change over time', 'nonInferiorityComment': 'Within subjects change over time', 'otherAnalysisDescription': 'Within subjects change over time.'}, {'pValue': '0.627', 'groupIds': ['OG000', 'OG001'], 'paramType': 'F test (1,15) df', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.246', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Between group analysis', 'otherAnalysisDescription': 'Between group analysis'}, {'pValue': '0.947', 'groupIds': ['OG000', 'OG001'], 'paramType': 'F test (1,15) df', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.005', 'groupDescription': 'Time x Condition interaction', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Time x Condition interaction'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-treatment (6 weeks)', 'description': 'Daily step counts as reported to study staff, after participants recorded them from wearable fitness trackers at end of day. Each assessment period consisted of 7 continuous days of wear. Summed totals of steps in the 7 day period were calculated, and then means calculated between groups of these summed step counts for the 7 day assessment period.', 'unitOfMeasure': 'Mean of total steps in 7 day period', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only some participants were able to record daily steps data due to complications with devices and COVID-19 protocols.'}, {'type': 'SECONDARY', 'title': 'Rapid Assessment of Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Engage PA', 'description': 'Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.'}, {'id': 'OG001', 'title': 'Treatment as Usual Plus Fitness Tracker', 'description': 'Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.25', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '3.16', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '3.47', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '2.31', 'spread': '1.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.88', 'ciLowerLimit': '-1.85', 'ciUpperLimit': '0.98', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-treatment (6 weeks)', 'description': 'The RAPA is a self-reported measure that assesses participants engagement in a variety of activities, such as light movement, moderate activity, vigorous activity, and other activities such as strength-training or yoga. Scores range from 0 - 7, where higher scores indicate greater involvement in physical activity overall.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected (n=1; TAU group) due to lost to follow up, data not analyzed (n=1; Engage PA group) due to assessment conducted out of window.'}, {'type': 'SECONDARY', 'title': 'Psychological Flexibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Engage PA', 'description': 'Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.'}, {'id': 'OG001', 'title': 'Treatment as Usual Plus Fitness Tracker', 'description': 'Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '13.95', 'spread': '8.20', 'groupId': 'OG000'}, {'value': '16.21', 'spread': '7.45', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment', 'categories': [{'measurements': [{'value': '14.72', 'spread': '8.37', 'groupId': 'OG000'}, {'value': '13.05', 'spread': '6.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.56', 'ciLowerLimit': '-6.05', 'ciUpperLimit': '0.94', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-treatment (6 weeks)', 'description': 'The Acceptance and Action Questionnaire-II asks about psychological flexibility, defined as how often thoughts, feelings and body sensations get in the way of living a fulfilling life. Responses are on a 1 to 7 Likert scale with 1 indicating that these issues never get in the way, and 7 indicating that these issues always get in the way. Range is 7 - 49, with lower scores indicating better outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected (n=1; TAU group) due to lost to follow up, data not analyzed (n=1; Engage PA group) due to assessment conducted out of window.'}, {'type': 'SECONDARY', 'title': 'Valued Living - Health Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Engage PA', 'description': 'Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.'}, {'id': 'OG001', 'title': 'Treatment as Usual Plus Fitness Tracker', 'description': 'Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.11', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '4.05', 'spread': '1.99', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '3.76', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '4.88', 'spread': '1.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-1.19', 'ciUpperLimit': '1.42', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-treatment (6 weeks)', 'description': 'The Bulls-Eye Values measure assesses how successfully participants are at living in line with 4 domains of personal values (relationships, leisure, health, and work) on a visual dart-board scale with 1 indicating perfect success, and 14 indicates being unsuccessful. Range for each domain is 1 - 14 with lower as better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected (n=1; TAU group) due to lost to follow up, data not analyzed (n=1; Engage PA group) due to assessment conducted out of window.'}, {'type': 'SECONDARY', 'title': 'Valued Living - Leisure Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Engage PA', 'description': 'Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.'}, {'id': 'OG001', 'title': 'Treatment as Usual Plus Fitness Tracker', 'description': 'Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.26', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '4.60', 'spread': '4.18', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '4.12', 'spread': '1.87', 'groupId': 'OG000'}, {'value': '4.18', 'spread': '2.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.72', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.029', 'ciLowerLimit': '-.194', 'ciUpperLimit': '1.42', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-treatment (6 weeks)', 'description': 'The Bulls-Eye Values measure assesses how successfully participants are at living in line with 4 domains of personal values (relationships, leisure, health, and work) on a visual dart-board scale with 1 indicating perfect success, and 14 indicates being unsuccessful. Range for each domain is 1 - 14 with lower as better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected (n=1; TAU group) due to lost to follow up, data not analyzed (n=1; Engage PA group) due to assessment conducted out of window.'}, {'type': 'SECONDARY', 'title': 'Valued Living - Relationship Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Engage PA', 'description': 'Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.'}, {'id': 'OG001', 'title': 'Treatment as Usual Plus Fitness Tracker', 'description': 'Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.68', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '4.29', 'spread': '2.29', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '4.00', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '4.35', 'spread': '2.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.341', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.23', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-treatment (6 weeks)', 'description': 'The Bulls-Eye Values measure assesses how successfully participants are at living in line with 4 domains of personal values (relationships, leisure, health, and work) on a visual dart-board scale with 1 indicating perfect success, and 14 indicates being unsuccessful.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected (n=1; TAU group) due to lost to follow up, data not analyzed (n=1; Engage PA group) due to assessment conducted out of window.'}, {'type': 'SECONDARY', 'title': 'Valued-Living - Work/Community Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Engage PA', 'description': 'Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.'}, {'id': 'OG001', 'title': 'Treatment as Usual Plus Fitness Tracker', 'description': 'Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.32', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '3.30', 'spread': '1.87', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment', 'categories': [{'measurements': [{'value': '3.65', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '3.41', 'spread': '2.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.059', 'ciLowerLimit': '-2.35', 'ciUpperLimit': '1.17', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, post-treatment (6 weeks)', 'description': 'The Bulls-Eye Values measure assesses how successfully participants are at living in line with 4 domains of personal values (relationships, leisure, health, and work) on a visual dart-board scale with 1 indicating perfect success, and 14 indicates being unsuccessful.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected (n=1; TAU group) due to lost to follow up, data not analyzed (n=1; Engage PA group) due to assessment conducted out of window.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Engage PA', 'description': 'Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.'}, {'id': 'FG001', 'title': 'Treatment as Usual Plus Fitness Tracker', 'description': 'Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Engage PA', 'description': 'Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.'}, {'id': 'BG001', 'title': 'Treatment as Usual Plus Fitness Tracker', 'description': 'Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.32', 'spread': '6.01', 'groupId': 'BG000'}, {'value': '71.20', 'spread': '4.42', 'groupId': 'BG001'}, {'value': '71.55', 'spread': '5.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', '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': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', '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': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-19', 'size': 174890, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-10-05T15:12', 'hasProtocol': True}, {'date': '2021-06-09', 'size': 225120, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-11-29T09:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-12', 'studyFirstSubmitDate': '2020-07-24', 'resultsFirstSubmitDate': '2022-10-05', 'studyFirstSubmitQcDate': '2020-07-24', 'lastUpdatePostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-12', 'studyFirstPostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Enrolled in the Study', 'timeFrame': '9 months', 'description': 'How many participants, up to the expected 40 participants, enroll in the study within the study period'}, {'measure': 'Number of Participants Who Completed the Entire Program', 'timeFrame': '6 weeks', 'description': 'Participants who complete all assessments and required study sessions'}, {'measure': 'Percentage of Participants Who Were Mostly or Very Satisfied With the Intervention', 'timeFrame': 'Post treatment (6 weeks)', 'description': 'Client Satisfaction Questionnaire asks 12 questions related to patient satisfaction on a Likert scale of 1 = very satisfied to 7 = very dissatisfied. There is one item assessing overall satisfaction with the intervention, and the percentage of participants responding to this item with "mostly" or "very" satisfied is reported below.'}], 'secondaryOutcomes': [{'measure': 'Arthritis Pain (AIMS 2 Symptom Subscale)', 'timeFrame': 'Baseline, post-treatment (6 weeks)', 'description': 'The Arthritis Impact Measurement Scale (AIMS 2) measures arthritis pain related disability across areas of living both with a total score and on several subscales (i.e., pain severity, physical functioning/pain-related disability, psychological distress), where 1 indicates very good functioning, and 5 indicates very poor functioning. Symptom subscale includes items assessing pain severity, stiffness, and physical discomfort. Range is 5 to 25 where higher scores indicate worse functioning.'}, {'measure': 'Arthritis-related Physical Functioning (AIMS 2 Physical Functioning Subscale)', 'timeFrame': 'Baseline, post-treatment (6 weeks)', 'description': 'The Arthritis Impact Measurement Scale (AIMS 2) measures arthritis pain related disability across areas of living on several subscales (i.e., pain severity, physical functioning/pain-related disability, psychological distress), where 1 indicates very good functioning, and 5 indicates very poor functioning. Physical functioning subscale includes items assessing mobility level, walking and bending, self-care and household tasks. Range is 5-25 where higher scores indicate worse functioning.'}, {'measure': 'Psychological Distress (AIMS 2 Affect Subscale)', 'timeFrame': 'Baseline, post-treatment (6 weeks)', 'description': 'The Arthritis Impact Measurement Scale (AIMS 2) measures arthritis pain related disability across areas of living on several subscales (i.e., pain severity, physical functioning/pain-related disability, psychological distress), where 1 indicates very good functioning, and 5 indicates very poor functioning. Psychological distress subscale includes items assessing mood and anxiety/tension. Range is 5-25 where higher scores indicate worse functioning.'}, {'measure': 'Daily Step Count in 7 Day Period', 'timeFrame': 'Baseline, post-treatment (6 weeks)', 'description': 'Daily step counts as reported to study staff, after participants recorded them from wearable fitness trackers at end of day. Each assessment period consisted of 7 continuous days of wear. Summed totals of steps in the 7 day period were calculated, and then means calculated between groups of these summed step counts for the 7 day assessment period.'}, {'measure': 'Rapid Assessment of Physical Activity', 'timeFrame': 'Baseline, post-treatment (6 weeks)', 'description': 'The RAPA is a self-reported measure that assesses participants engagement in a variety of activities, such as light movement, moderate activity, vigorous activity, and other activities such as strength-training or yoga. Scores range from 0 - 7, where higher scores indicate greater involvement in physical activity overall.'}, {'measure': 'Psychological Flexibility', 'timeFrame': 'Baseline, post-treatment (6 weeks)', 'description': 'The Acceptance and Action Questionnaire-II asks about psychological flexibility, defined as how often thoughts, feelings and body sensations get in the way of living a fulfilling life. Responses are on a 1 to 7 Likert scale with 1 indicating that these issues never get in the way, and 7 indicating that these issues always get in the way. Range is 7 - 49, with lower scores indicating better outcomes.'}, {'measure': 'Valued Living - Health Domain', 'timeFrame': 'Baseline, post-treatment (6 weeks)', 'description': 'The Bulls-Eye Values measure assesses how successfully participants are at living in line with 4 domains of personal values (relationships, leisure, health, and work) on a visual dart-board scale with 1 indicating perfect success, and 14 indicates being unsuccessful. Range for each domain is 1 - 14 with lower as better outcome.'}, {'measure': 'Valued Living - Leisure Domain', 'timeFrame': 'Baseline, post-treatment (6 weeks)', 'description': 'The Bulls-Eye Values measure assesses how successfully participants are at living in line with 4 domains of personal values (relationships, leisure, health, and work) on a visual dart-board scale with 1 indicating perfect success, and 14 indicates being unsuccessful. Range for each domain is 1 - 14 with lower as better outcome.'}, {'measure': 'Valued Living - Relationship Domain', 'timeFrame': 'Baseline, post-treatment (6 weeks)', 'description': 'The Bulls-Eye Values measure assesses how successfully participants are at living in line with 4 domains of personal values (relationships, leisure, health, and work) on a visual dart-board scale with 1 indicating perfect success, and 14 indicates being unsuccessful.'}, {'measure': 'Valued-Living - Work/Community Domain', 'timeFrame': 'Baseline, post-treatment (6 weeks)', 'description': 'The Bulls-Eye Values measure assesses how successfully participants are at living in line with 4 domains of personal values (relationships, leisure, health, and work) on a visual dart-board scale with 1 indicating perfect success, and 14 indicates being unsuccessful.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Engage PA', 'treatment as usual'], 'conditions': ['Osteoarthritis, Knee', 'Osteoarthritis, Hip']}, 'referencesModule': {'references': [{'pmid': '35915512', 'type': 'DERIVED', 'citation': 'Plumb Vilardaga JC, Kelleher SA, Diachina A, Riley J, Somers TJ. Linking physical activity to personal values: feasibility and acceptability randomized pilot of a behavioral intervention for older adults with osteoarthritis pain. Pilot Feasibility Stud. 2022 Aug 1;8(1):164. doi: 10.1186/s40814-022-01121-0.'}, {'pmid': '35018370', 'type': 'DERIVED', 'citation': 'Vilardaga JCP, Kelleher S, Diachina A, Riley J, Somers T. Linking Physical Activity to Personal Values: Feasibility and Acceptability Randomized Pilot of a Behavioral Intervention for Older Adults with Osteoarthritis Pain. Res Sq [Preprint]. 2022 Jan 3:rs.3.rs-1182374. doi: 10.21203/rs.3.rs-1182374/v1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate how older adults might benefit from sessions that teach behavioral coping skills for increasing physical activity and reducing interference from arthritis pain. This study will randomize individuals to receive Engage-PA, or continue to receive treatment as usual. Engage-PA involves two sessions (about 45 minutes each) with a study therapist that teaches individuals behavioral skills for increasing daily steps. These behavioral skills include identifying their personal values and instructions on how to pace their daily physical activity to avoid creating severe pain when walking. All participants in the study will wear small devices that track physical activity such as daily steps throughout the study, which also allow participants to see their daily step counts and overall level of activity. All participants will answer a set of questions about how much arthritis gets the way of many important life activities, their success at living in line with their personal values, and how much thoughts, feelings and body sensations get in the way of living a satisfying life. These questions will be asked at the beginning of the study and 6 weeks into the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 65 or older\n* English speaking\n* Diagnosis of osteoarthritis in knee or hip\n* Able to ambulate even if assisted with ambulatory device such as walker or cane\n* Endorse worst pain and pain interference as ≥ 3 out of 10 within the last week\n\nExclusion Criteria:\n\n* Planned surgery during study duration that would limit mobility (e.g., due to recommended rehabilitation or recovery period) for more than 3 weeks\n* Current enrollment in cardiac rehabilitation\n* Myocardial infarction in the past 3 months\n* Major surgery requiring limited movement or mobility for recovery within the past 3 months\n* Presence of a serious psychiatric condition (e.g., schizophrenia, suicidal intent) indicated by medical chart, treating medical provider or other staff, or study staff interactions that would contraindicate safe study participation\n* Medical provider indicating that exercise (even walking) should only be medically supervised; as determined by medical record review or patient reported\n* Fall or falls within the last 3 months that led to immediate medical treatment/hospitalization\n* Reported or suspected moderate or severe cognitive impairment subsequently informed by a Folstein Mini-Mental Status Examination of \\<19'}, 'identificationModule': {'nctId': 'NCT04490395', 'briefTitle': 'Increasing Physical Activity in Older Adults With Osteoarthritis Pain: Examining a Brief Behavioral Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Increasing Physical Resilience in Older Adults With Osteoarthritis Pain: Feasibility and Acceptability of a Brief Behavioral Physical Activity Intervention', 'orgStudyIdInfo': {'id': 'Pro00105573'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Engage PA', 'interventionNames': ['Behavioral: Engage PA']}, {'type': 'OTHER', 'label': 'Treatment as usual plus fitness tracker', 'interventionNames': ['Other: Treatment as Usual plus (TAU+)']}], 'interventions': [{'name': 'Engage PA', 'type': 'BEHAVIORAL', 'description': 'Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.', 'armGroupLabels': ['Engage PA']}, {'name': 'Treatment as Usual plus (TAU+)', 'type': 'OTHER', 'description': 'The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.', 'armGroupLabels': ['Treatment as usual plus fitness tracker']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Jennifer Plumb Vilardaga, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}