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| ID | Type | Description | Link |
|---|---|---|---|
| I21RX002898-01A1 | U.S. NIH Grant/Contract | View source |
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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.
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.
The 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.
The 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I'm Whole | Experimental | 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. |
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| Education + usual care | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I'm Whole | Behavioral | I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. |
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| Measure | Description | Time Frame |
|---|---|---|
| Stroke Specific Quality of Life Scale Change | 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. | Absolute values at 12 weeks post-treatment are being reported |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity and Disability Survey Change | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gina L. Evans, PhD | Michael E. DeBakey VA Medical Center, Houston, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | I'm Whole | 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. I'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. |
| FG001 | Education + Usual Care | 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. Education + 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | I'm Whole | 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. I'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stroke Specific Quality of Life Scale Change | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Absolute values at 12 weeks post-treatment are being reported |
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Adverse data was collected for 1 year and 6 months.
The definition does not differ from that defined by clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | I'm Whole | 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. I'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. |
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The small sample size is a limitation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gina Evans | Michael E. Debakey VA Medical Center | 832-269-3048 | gina.evans@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2023 | Sep 24, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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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).
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No other parties will be masked
| Education + usual care | Other | 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. |
|
| The absolute values at 12 weeks post-treatment are being reported |
| Community Integration Questionnaire Change | 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. | The absolute values at 12 weeks post-treatment are being reported |
| Patient Health Questionnaire-8 Item Change | 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. | The absolute values at 12 weeks post-treatment are being reported |
| General Anxiety Disorder-7 Change | 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. | The absolute values at 12 weeks post-treatment are being reported |
| BG001 | Education + Usual Care | 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. Education + 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| International physical activity questionnaire | Mean | Standard Deviation | MET Minutes per day |
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| Sedentary Behaviors Questionnaire | Mean | Standard Deviation | hours spent in sedentary behaviors |
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| Community Integration Questionnaire | Total score range is 13-39. Lower values represent a better outcome and greater integration into the community. | Mean | Standard Deviation | units on a scale |
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| Patient-Reported Outcomes Measurement Information System | The scores range from 0 - 100. Higher scores indicate greater difficulties with overall health functioning. | Mean | Standard Deviation | units on a scale |
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| Generalized Anxiety Disorder-7 items | Total score range is 0-21. Lower values represent a better outcome and less symptoms of anxiety. | Mean | Standard Deviation | units on a scale |
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| Patient Health Questionnaire | Total score range is 0-24. Lower values represent a better outcome and less symptoms of depression. | Mean | Standard Deviation | units on a scale |
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| 36-Item Short Form Survey | 0 to 100, with lower scores denoting poorer health | Mean | Standard Deviation | units on a scale |
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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. I'm Whole: I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration. |
| OG001 | Education + Usual Care | 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. Education + 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. |
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| Secondary | Physical Activity and Disability Survey Change | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | The absolute values at 12 weeks post-treatment are being reported |
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|
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| Secondary | Community Integration Questionnaire Change | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | The absolute values at 12 weeks post-treatment are being reported |
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|
|
| Secondary | Patient Health Questionnaire-8 Item Change | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | The absolute values at 12 weeks post-treatment are being reported |
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|
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| Secondary | General Anxiety Disorder-7 Change | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | The absolute values at 12 weeks post-treatment are being reported |
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|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Education + Usual Care | 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. Education + 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. | 0 | 19 | 0 | 19 | 0 | 19 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |