Improving Quality of Life for Veterans With Stroke and Psychological Distress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Stroke Specific Quality of Life Scale Change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
No other parties will be masked
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Stroke Specific Quality of Life Scale Change
时间窗: 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.
次要结局
- 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)