Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-29 @ 4:08 PM
Study NCT ID:
NCT03645759
Status:
COMPLETED
Last Update Posted:
2024-07-18
First Post:
2018-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Quality of Life for Veterans With Stroke and Psychological Distress
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gina.evans@va.gov', 'phone': '832-269-3048', 'title': 'Dr. Gina Evans', 'organization': 'Michael E. Debakey VA Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The small sample size is a limitation.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse data was collected for 1 year and 6 months.', 'description': 'The definition does not differ from that defined by clinicaltrials.gov.', 'eventGroups': [{'id': 'EG000', 'title': "I'm Whole", 'description': "This arm will receive 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. Treatments will occur weekly. They will also receive 3 assessments at 0, 6, and 12 weeks.\n\nI'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration.", 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Education + Usual Care', 'description': 'This arm will only receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.\n\nEducation + usual care: Will receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stroke Specific Quality of Life Scale Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "I'm Whole", 'description': "This arm will receive 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. Treatments will occur weekly. They will also receive 3 assessments at 0, 6, and 12 weeks.\n\nI'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration."}, {'id': 'OG001', 'title': 'Education + Usual Care', 'description': 'This arm will only receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.\n\nEducation + usual care: Will receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.24', 'spread': '6.30', 'groupId': 'OG000'}, {'value': '41.67', 'spread': '5.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Absolute values at 12 weeks post-treatment are being reported', 'description': 'The Stroke Specific Quality of Life Scale assesses change in energy, language, vision, mobility, fine motor tasks, mood, personality and thinking, social roles, family roles and work productivity. Scores are reported for the energy, language, mobility, personality, mood, family roles, thinking, and social roles. The score range for each item 1= strongly disagree to 5=strongly agree with a higher score indicating greater disability and worst outcomes. A total score range is 14-70.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Estimates of changes in patient-reported outcomes were calculated using intent to-treat approach. The paired change in outcome scores from baseline to the end of the study and differences in paired change in scores in treatment and EUC arms were compared with zero using Wilcoxon's signed-rank test."}, {'type': 'SECONDARY', 'title': 'Physical Activity and Disability Survey Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "I'm Whole", 'description': "This arm will receive 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. Treatments will occur weekly. They will also receive 3 assessments at 0 and 12 weeks.\n\nI'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration."}, {'id': 'OG001', 'title': 'Education + Usual Care', 'description': 'This arm will only receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.\n\nEducation + usual care: Will receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.'}], 'classes': [{'categories': [{'measurements': [{'value': '602', 'spread': '48', 'groupId': 'OG000'}, {'value': '60', 'spread': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The absolute values at 12 weeks post-treatment are being reported', 'description': 'The Physical Activity and Disability Survey measures change in exercise, leisure time physical activity, indoor and outdoor household activity, wheelchair ambulation, employment-related activity and rehabilitation therapy-related activity. Scores were reported for each 6 areas of exercise/activity. The subscale score is based on the self-reported amount of time an individual states they spend performing each exercise. Higher values represent a better outcome and more time spent engaging in the activity. The range of scores are 0-1440 minutes per day.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Estimates of changes in patient-reported outcomes were calculated using intent to-treat approach. The paired change in outcome scores from baseline to the end of the study and differences in paired change in scores in treatment and EUC arms were compared with zero using Wilcoxon's signed-rank test."}, {'type': 'SECONDARY', 'title': 'Community Integration Questionnaire Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "I'm Whole", 'description': "This arm will receive 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. Treatments will occur weekly. They will also receive 3 assessments at 0 and 12 weeks.\n\nI'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration."}, {'id': 'OG001', 'title': 'Education + Usual Care', 'description': 'This arm will only receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.\n\nEducation + usual care: Will receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.8', 'spread': '4.21', 'groupId': 'OG000'}, {'value': '13.8', 'spread': '4.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The absolute values at 12 weeks post-treatment are being reported', 'description': 'The Community Integration Questionnaire measures change in home integration (i.e., market, meal preparation, household activities, finance), social integration (i.e., shopping, avocation, going out), and productive activity (i.e., work, school, volunteer activity). The score range is 1=you yourself alone 3=someone else. Total score range is 13-39. Lower values represent a better outcome and greater integration into the community.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Estimates of changes in patient-reported outcomes were calculated using intent to-treat approach. The paired change in outcome scores from baseline to the end of the study and differences in paired change in scores in treatment and EUC arms were compared with zero using Wilcoxon's signed-rank test."}, {'type': 'SECONDARY', 'title': 'Patient Health Questionnaire-8 Item Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "I'm Whole", 'description': "This arm will receive 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. Treatments will occur weekly. They will also receive 3 assessments at 0 and 12 weeks.\n\nI'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration."}, {'id': 'OG001', 'title': 'Education + Usual Care', 'description': 'This arm will only receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.\n\nEducation + usual care: Will receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '8.21', 'spread': '0.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The absolute values at 12 weeks post-treatment are being reported', 'description': 'The Patient Health Questionnaire-8 assesses change in severity of depression symptoms over the last two weeks. The score range is 0=Not at all to 3=Nearly every day. Total score range is 0-24. Lower values represent a better outcome and less symptoms of depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Estimates of changes in patient-reported outcomes were calculated using intent to-treat approach. The paired change in outcome scores from baseline to the end of the study and differences in paired change in scores in treatment and EUC arms were compared with zero using Wilcoxon's signed-rank test."}, {'type': 'SECONDARY', 'title': 'General Anxiety Disorder-7 Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "I'm Whole", 'description': "This arm will receive 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. Treatments will occur weekly. They will also receive 3 assessments at 0 and 12 weeks.\n\nI'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration."}, {'id': 'OG001', 'title': 'Education + Usual Care', 'description': 'This arm will only receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.\n\nEducation + usual care: Will receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.80', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '3.91', 'spread': '1.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The absolute values at 12 weeks post-treatment are being reported', 'description': 'The General Anxiety Disorder-7 assesses change in severity of anxiety symptoms over the last two weeks. The total score is reported. The score range is 0=Not at all to 3=Nearly every day. Total score range is 0-21. Lower values represent a better outcome and less symptoms of anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Estimates of changes in patient-reported outcomes were calculated using intent to-treat approach. The paired change in outcome scores from baseline to the end of the study and differences in paired change in scores in treatment and EUC arms were compared with zero using Wilcoxon's signed-rank test."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': "I'm Whole", 'description': "This arm will receive 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. Treatments will occur weekly. They will also receive 3 assessments at 0 and 12 weeks.\n\nI'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration."}, {'id': 'FG001', 'title': 'Education + Usual Care', 'description': 'This arm will only receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.\n\nEducation + usual care: Will receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': "I'm Whole", 'description': "This arm will receive 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. Treatments will occur weekly. They will also receive 3 assessments at 0, 6, and 12 weeks.\n\nI'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration."}, {'id': 'BG001', 'title': 'Education + Usual Care', 'description': 'This arm will only receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.\n\nEducation + usual care: Will receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.'}, {'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': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.44', 'spread': '3.77', 'groupId': 'BG000'}, {'value': '63.44', 'spread': '4.27', 'groupId': 'BG001'}, {'value': '64.44', 'spread': '2.87', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', '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': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'International physical activity questionnaire', 'classes': [{'categories': [{'measurements': [{'value': '203', 'spread': '284', 'groupId': 'BG000'}, {'value': '143', 'spread': '233.9', 'groupId': 'BG001'}, {'value': '173', 'spread': '258.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'MET Minutes per day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sedentary Behaviors Questionnaire', 'classes': [{'categories': [{'measurements': [{'value': '5.73', 'spread': '9.49', 'groupId': 'BG000'}, {'value': '4.51', 'spread': '1.40', 'groupId': 'BG001'}, {'value': '5.12', 'spread': '5.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'hours spent in sedentary behaviors', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Community Integration Questionnaire', 'classes': [{'categories': [{'measurements': [{'value': '18.60', 'spread': '4.60', 'groupId': 'BG000'}, {'value': '29.70', 'spread': '4.41', 'groupId': 'BG001'}, {'value': '24.15', 'spread': '4.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total score range is 13-39. Lower values represent a better outcome and greater integration into the community.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient-Reported Outcomes Measurement Information System', 'classes': [{'categories': [{'measurements': [{'value': '64.04', 'spread': '5.32', 'groupId': 'BG000'}, {'value': '61.01', 'spread': '9.10', 'groupId': 'BG001'}, {'value': '62.53', 'spread': '7.21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The scores range from 0 - 100. Higher scores indicate greater difficulties with overall health functioning.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Generalized Anxiety Disorder-7 items', 'classes': [{'categories': [{'measurements': [{'value': '4.80', 'spread': '0.70', 'groupId': 'BG000'}, {'value': '4.52', 'spread': '1.01', 'groupId': 'BG001'}, {'value': '4.65', 'spread': '0.85', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total score range is 0-21. Lower values represent a better outcome and less symptoms of anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Health Questionnaire', 'classes': [{'categories': [{'measurements': [{'value': '11.01', 'spread': '0.91', 'groupId': 'BG000'}, {'value': '10.10', 'spread': '0.70', 'groupId': 'BG001'}, {'value': '10.55', 'spread': '0.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total score range is 0-24. Lower values represent a better outcome and less symptoms of depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '36-Item Short Form Survey', 'classes': [{'categories': [{'measurements': [{'value': '40.23', 'spread': '9.15', 'groupId': 'BG000'}, {'value': '51.39', 'spread': '10.96', 'groupId': 'BG001'}, {'value': '45.81', 'spread': '10.06', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '0 to 100, with lower scores denoting poorer health', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-22', 'size': 508236, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-24T12:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'No other parties will be masked'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Behavioral treatment intervention that focuses on enhancing stroke self-management, psychological distress and social functioning that will be provided to two groups (treatment and education plus usual care).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2018-08-21', 'resultsFirstSubmitDate': '2022-10-19', 'studyFirstSubmitQcDate': '2018-08-22', 'lastUpdatePostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-17', 'studyFirstPostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stroke Specific Quality of Life Scale Change', 'timeFrame': 'Absolute values at 12 weeks post-treatment are being reported', 'description': 'The Stroke Specific Quality of Life Scale assesses change in energy, language, vision, mobility, fine motor tasks, mood, personality and thinking, social roles, family roles and work productivity. Scores are reported for the energy, language, mobility, personality, mood, family roles, thinking, and social roles. The score range for each item 1= strongly disagree to 5=strongly agree with a higher score indicating greater disability and worst outcomes. A total score range is 14-70.'}], 'secondaryOutcomes': [{'measure': 'Physical Activity and Disability Survey Change', 'timeFrame': 'The absolute values at 12 weeks post-treatment are being reported', 'description': 'The Physical Activity and Disability Survey measures change in exercise, leisure time physical activity, indoor and outdoor household activity, wheelchair ambulation, employment-related activity and rehabilitation therapy-related activity. Scores were reported for each 6 areas of exercise/activity. The subscale score is based on the self-reported amount of time an individual states they spend performing each exercise. Higher values represent a better outcome and more time spent engaging in the activity. The range of scores are 0-1440 minutes per day.'}, {'measure': 'Community Integration Questionnaire Change', 'timeFrame': 'The absolute values at 12 weeks post-treatment are being reported', 'description': 'The Community Integration Questionnaire measures change in home integration (i.e., market, meal preparation, household activities, finance), social integration (i.e., shopping, avocation, going out), and productive activity (i.e., work, school, volunteer activity). The score range is 1=you yourself alone 3=someone else. Total score range is 13-39. Lower values represent a better outcome and greater integration into the community.'}, {'measure': 'Patient Health Questionnaire-8 Item Change', 'timeFrame': 'The absolute values at 12 weeks post-treatment are being reported', 'description': 'The Patient Health Questionnaire-8 assesses change in severity of depression symptoms over the last two weeks. The score range is 0=Not at all to 3=Nearly every day. Total score range is 0-24. Lower values represent a better outcome and less symptoms of depression.'}, {'measure': 'General Anxiety Disorder-7 Change', 'timeFrame': 'The absolute values at 12 weeks post-treatment are being reported', 'description': 'The General Anxiety Disorder-7 assesses change in severity of anxiety symptoms over the last two weeks. The total score is reported. The score range is 0=Not at all to 3=Nearly every day. Total score range is 0-21. Lower values represent a better outcome and less symptoms of anxiety.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['behavioral treatment', 'telehealth', 'stroke self-management', 'psychological distress', 'social integration'], 'conditions': ['Stroke', 'Depression', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'The study will create a treatment to improves mobility, physical activity, engagement in activities with family and friends and overall satisfaction with life for Veterans who have depression and anxiety after having a stroke. The treatment will then be tested to ensure it makes the desired improvements in the Veterans.', 'detailedDescription': "The study has three aims. The first aim is to develop a client-centered, behavioral stroke self-management program (I'm Whole) for Veterans with stroke and psychological distress (e.g., symptoms of anxiety and/or depression). This will be done using expert input from a multidisciplinary team of a clinical psychologist, nurse practitioner, exercise physiologist and social role functioning expert will be used to create the I'm Whole patient workbook and clinician manual.\n\nThe second aim is to pilot the I'm Whole treatment by delivering the intervention to 5 Veterans suffering from stroke and comorbid depression and/or anxiety symptoms. The feasibility (barriers and facilitators to completing I'm Whole and acceptability of the intervention) will be assessed through qualitative interviews posttreatment. Veterans' feedback about ways to improve I'm Whole will be analyzed and used to improve treatment.\n\nThe third aim is to test the feasibility and preliminary efficacy of I'm Whole on quality of life (primary outcome) physical functioning, physical activity, social role functioning, psychological distress, and satisfaction with I'm Whole (secondary outcomes). To test the feasibility and efficacy, a small randomized controlled trial (RCT) with 30 Veterans (15 I'm Whole and 15 education+usual care) with stroke and psychological distress will be conducted."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a documented history of stroke and/or transient ischemic attack within the last 30 days\n* a modified Rankin score of \\> 3)\n* regular access to a computer or tablet with internet and a camera\n* ability to give appropriate informed consent\n* score \\> 5 on a measure of depression (Patient Health Questionnaire \\[PHQ-8\\]) and/or \\>17 on a measure of anxiety (Generalized Anxiety Disorder-7 \\[GAD-7\\]) assessments\n* ability to ambulate with or without assistance of a cane or walker\n\nExclusion Criteria:\n\n* cognitive impairment, as evidenced by a score of \\>3 on a brief cognitive screener\n* documented diagnosis of psychotic disorder or schizophrenia\n* documented severe depression, anxiety (based on PHQ-8 or GAD-7 score of \\> 20), or hospitalization for psychiatric illness within the past 30 days'}, 'identificationModule': {'nctId': 'NCT03645759', 'briefTitle': 'Improving Quality of Life for Veterans With Stroke and Psychological Distress', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Improving Quality of Life for Veterans With Stroke and Psychological Distress', 'orgStudyIdInfo': {'id': 'D2898-P'}, 'secondaryIdInfos': [{'id': 'I21RX002898-01A1', 'link': 'https://reporter.nih.gov/quickSearch/I21RX002898-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "I'm Whole", 'description': 'This arm will receive 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. Treatments will occur weekly. They will also receive 3 assessments at 0, 6, and 12 weeks.', 'interventionNames': ["Behavioral: I'm Whole"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Education + usual care', 'description': 'This arm will only receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.', 'interventionNames': ['Other: Education + usual care']}], 'interventions': [{'name': "I'm Whole", 'type': 'BEHAVIORAL', 'description': "I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration.", 'armGroupLabels': ["I'm Whole"]}, {'name': 'Education + usual care', 'type': 'OTHER', 'description': 'Will receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.', 'armGroupLabels': ['Education + usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael E. DeBakey VA Medical Center, Houston, TX', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Gina L. Evans, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michael E. DeBakey VA Medical Center, Houston, TX'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}