Improving Quality of Life for Veterans With Stroke and Psychological Distress

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving Quality of Life for Veterans With Stroke and Psychological Distress

Conditions
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Stroke, Depression, Anxiety

Intervention / Treatment
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* Behavioral: I'm Whole
* Other: Education + usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a documented history of stroke and/or transient ischemic attack within the last 30 days a modified Rankin score of > 3) regular access to a computer or tablet with internet and a camera ability to give appropriate informed consent 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 ability to ambulate with or without assistance of a cane or walker Exclusion Criteria: cognitive impairment, as evidenced by a score of >3 on a brief cognitive screener documented diagnosis of psychotic disorder or schizophrenia documented severe depression, anxiety (based on PHQ-8 or GAD-7 score of > 20), or hospitalization for psychiatric illness within the past 30 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I'm Whole<br>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. | Behavioral: I'm Whole<br>* I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration.<br>|
| Active Comparator: Education + usual care<br>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. | Other: Education + usual care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke Specific Quality of Life Scale Change | The scale assesses change in energy, language, vision, mobility, fine motor tasks, mood, personality and thinking, social roles, family roles and work productivity. Subscale scores will be reported for the energy, language, mobility, personality, mood, family roles, thinking, and social roles. The score range for each subscale is 1=need total help to 5=need no help at all. | Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke Impact Scale Change | The scale assesses change in exercise, leisure time physical activity, indoor and outdoor household activity, wheelchair ambulation, employment-related activity, and rehabilitation therapy-related activity. The total score is reported and the total range will be provided. The score range is 1=All of the time 5=None of the time. Higher values represent a better outcome. | Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment | 
| Physical Activity and Disability Survey Change | The survey measures change in exercise, leisure time physical activity, indoor and outdoor household activity, wheelchair ambulation, employment-related activity and rehabilitation therapy-related activity. Subscale scores will be 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. | Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment | 
| Subjective Index of Physical and Social Outcome Change | The survey measures change in a patient's subjective assessment of his/her social integration after a stroke in physical and social components. The two subscale scores will be reported. The score range for each subscale is 0=poor integration to 4=highly integrated. Higher values represent a better outcome. | Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment | 
| Community Integration Questionnaire Change | The 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). Subscale scores will be reported for each subscale. The score range for each subscale is 1=you yourself alone 3=someone else. Lower values represent a better outcome. | Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment | 
| Patient Health Questionnaire-8 item Change | The questionnaire assesses change in severity of depression symptoms over the last two weeks. The total score is reported and the total range will be provided. The score range is 0=Not at all to 3=Nearly every day. Lower values represent a better outcome. | Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment | 
| General Anxiety Disorder-7 Change | The questionnaire assesses change severity of anxiety symptoms over the last two weeks. The total score is reported and the total range will be provided. The score range is 0=Not at all to 3=Nearly every day. Lower values represent a better outcome. | Assessments will be administered at 0, 6 weeks, and 12 weeks posttreatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behavioral treatment, telehealth, stroke self-management, psychological distress, social integration