Improving Quality of Life for Veterans With Stroke and Psychological Distress
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- VA Office of Research and Development
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Stroke Specific Quality of Life Scale Change
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Stroke Specific Quality of Life Scale Change
Time Frame: Absolute values at 12 weeks post-treatment are being reported
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.
Secondary Outcomes
- Patient Health Questionnaire-8 Item Change(The absolute values at 12 weeks post-treatment are being reported)
- Community Integration Questionnaire Change(The absolute values at 12 weeks post-treatment are being reported)
- Physical Activity and Disability Survey Change(The absolute values at 12 weeks post-treatment are being reported)
- General Anxiety Disorder-7 Change(The absolute values at 12 weeks post-treatment are being reported)