Self-management EdUcation and SuPport to Promote PsychOsocial Health Among StRoke Survivors and Informal Caregivers in a VirTual Stroke Community (SUPPORT): A Pilot Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Acceptability as assessed by the number of VE Meetings attended
研究概览
简要总结
The purpose of this study is to create a virtual stroke community for stroke survivors and informal caregivers of stroke survivors by customizing an existing VE intervention to incorporate real-time, stroke-specific, psychosocial self management education (SME) and social interactions, to test feasibility, acceptability, and usability of the customized intervention for stroke survivors and informal caregivers of stroke survivors and to obtain and explore data to derive evidence-based hypotheses and properly design and conduct a future, larger trial to demonstrate treatment efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Stroke survivors that have experienced an ischemic or hemorrhagic stroke event and their caregivers
- •can read, write, and speak English
- •are able to provide written consent
- •are computer literate (have used a computer for ≥1 month)
- •have access to a computer with broadband internet at home
- •understand how to use the Internet (accessed the Internet on ≥2 occasions)
排除标准
- •reside outside of the home
- •Montreal Cognitive Assessment score of <9 indicating moderate to severe impairment
- •Caregivers that provide long-distance care. I
结局指标
主要结局
Acceptability as assessed by the number of VE Meetings attended
时间窗: post intervention (8 weeks from baseline)
Usability as assessed by the perceived usefulness score
时间窗: post intervention (8 weeks from baseline)
Usability as assessed by the perceived ease of use scores
时间窗: post intervention (8 weeks from baseline)
This has 10 items, each scored form 1(strongly disagree) to 5(strongly agree), higher score meaning higher perceived ease of use
Usability as assessed by the number of times the participants log in
时间窗: post intervention (8 weeks from baseline)
Feasibility as assessed by the number of participants enrolled in the study
时间窗: post intervention (8 weeks from baseline of last participant )
This will be defined as the number enrolled divided by the number of eligible individuals screened
Feasibility as assessed by the number of participants who complete the data collection forms
时间窗: post intervention (8 weeks from baseline of last participant )
Feasibility as assessed by the number of participants who complete the study
时间窗: post intervention (8 weeks from baseline of last participant )
Usability as assessed by the time spent in the environment in minutes
时间窗: post intervention (8 weeks from baseline)
Acceptability as assessed by the number of VE objects manipulated
时间窗: post intervention (8 weeks form baseline)
Objects manipulated are the resources interacted with
次要结局
- Change in perceived social support as assessed by the Multidimensional Scale of Perceived Social Support (MSPSS)(Baseline, post intervention (8 weeks after baseline))
- Change in anxiety as assessed by the Generalized Anxiety Disorder-7 score(Baseline, post intervention (8 weeks after baseline))
- Change in caregiver burden as assessed by the Zarit Burden Interview (ZBI)(Baseline, post intervention (8 weeks after baseline))
- Change in ability to recover form stress as measured by the Brief Resilience Scale(Baseline, post intervention (8 weeks after baseline))
- Change in loneliness as assessed by the UCLA loneliness scale scores(Baseline, post intervention (8 weeks after baseline))
- Change in self efficacy ( ability to perform tasks or behaviors) as assessed by the PROMIS General Self-efficacy Form(Baseline, post intervention (8 weeks after baseline))
- Change in emotional support as assessed by the NIH Emotional Support Form(Baseline, post intervention (8 weeks after baseline))
- Change in post stroke depression as assessed by the Patient Health Questionnaire-9 score (PHQ-9)(Baseline, post intervention (8 weeks after baseline))
- Change in instrumental support as assessed by the PROMIS Short Form v2.0(Baseline, post intervention (8 weeks after baseline))
- Change in the amount that pain interferes with daily life as assessed by the PROMIS Short Form Pain Interference v 1.0 8a(Baseline, post intervention (8 weeks after baseline))
研究者
Jennifer Beauchamp
Associate Professor
The University of Texas Health Science Center, Houston