Development of an Online Mindfulness Program for Stroke Survivors and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in Stroke Impact Scale
研究概览
简要总结
The purpose of this study is to test the relevance, satisfaction and ease-of-use of an online mindfulness intervention among stroke survivors and their caregivers. Quality of life, depression, anxiety, stress and sleep quality will be assessed before, after and at 1 month after the intervention. After the intervention, participants' feedback about the usability and the satisfaction with the intervention and the online program will be gathered. Based on participants' feedback, changes to the intervention will be made to obtain a final version.
详细描述
The incidence of depression and anxiety is much higher in stroke survivors and their caregivers compared to age-matched peers. Previous work suggests that mindfulness delivered in an online format is promising for both individuals with neurological disorders and caregivers to improve quality of life and psychological well-being.
The overall objective of this project is to develop and refine an online mindfulness program that is perceived as relevant and user-friendly for stroke survivors and their caregivers. This project also aims to determine the potential impact of the mindfulness program on psychological well-being for stroke survivors and caregivers to guide the development of a future intervention study.
The process of development of the online mindfulness program will be iterative and will involve three phases: one development phase, one usability testing phase with end-users and one refinement phase.
Phase 1) The 3-week online mindfulness program will be adapted from the program developed for individuals with amyotrophic lateral sclerosis by mindfulness and stroke experts to ensure suitability and relevance for individuals with stroke.
Phase 2) A testing phase will be conducted remotely for both technical and clinical verification with 5-10 stroke survivors and 5-10 caregivers. Self-reported questionnaires about psychological well-being will be administered prior to and after the participation to the program and at a 1-month follow-up. After the program, a usability questionnaire and a semi-structured interview will be conducted to assess the usability of the mindfulness program and gather participants' feedback. For each group, differences prior to and after the mindfulness program will be assessed using a repeated measure analysis of variance. The transcribed verbatim of the semi-structured interview will be analyzed independently using thematic content analysis by 2 members of the research team.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of stroke (for stroke survivors) or caregiver of someone who have had a stroke
- •Ability to access Internet using a computer, a tablet and/or a smart phone
- •Ability to provide informed consent
- •Fluent in English
排除标准
- •Severe language impairments
- •Regular meditation or participation in a mindfulness program in the past 3 months
结局指标
主要结局
Change in Stroke Impact Scale
时间窗: from baseline to 3 weeks
Quality of life and impact of stroke after the intervention. The Stroke Impact Scale is a 59-item measure and is divided in 8 domains. Scores range from 0-100 (with higher score showing better quality of life and lower stroke impact).
次要结局
- Change in World Health Organization Quality of Life-bref(from baseline to 3 weeks)
- Change in National Institute of Health Perceived Stress Survey(from baseline to 3 weeks)
- Adapted Post-Study System Usability Questionnaire(3 weeks)
- Change in Hospital Anxiety and Depression Scale(from baseline to 3 weeks)
- Change in Single-Item Sleep Quality Scale(from baseline to 3 weeks)
- Change in Zarit Burden Interview(from baseline to 3 weeks)
研究者
Carolee Winstein
Professor
University of Southern California