Co-developing a Bio-experiential Approach and Intervention to Support the Mental Health and Well-being of Dementia Patients and Their Caregivers at Home (TEND)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Engagement
研究概览
简要总结
The goal of this project is to conduct an open pilot (N=5) among dyads (persons living with dementia and their caregivers) to assess the preliminary effects of an online videogame platform. The "Isle of TEND" is an immersive and interactive videogame platform designed for persons living with dementia and their caregivers. Dyads will use the platform three to four times a week for 20-30 minutes across four weeks. The investigators will assess for improvements in relationship satisfaction, wellbeing, and positive emotions and gather feedback on engagement in the platform. Dyads will complete measures at baseline and post-intervention as well as brief measures after each platform use.
详细描述
The aim of this phase is to assess initial active engagement, sustained attention, and positive emotions of the "Isle of TEND" intervention platform. Our participants (N = 5 dyads) will be persons living with moderate-severe dementia and their caregivers in the Boston area.
The intervention, "Isle of TEND" is an immersive and interactive videogame platform designed for persons living with dementia and their caregivers. Studio Elsewhere, a design and development team, developed the platform in consideration with feedback generated from focus groups and design workshops. Users navigate the online island and explore accompanying modules with varying audio and visual features. The platform aims to engage dyads in an enjoyable, shared, and "error-free" experience (i.e., creating poetry, viewing virtual art).
Participants will use their personal "travel journal" after each platform session, in which they log engagement and positive emotion. Dyads are also encouraged to provide free response feedback on the platform. Once a week, dyads will record themselves as they use the platform. The investigators will conclude the pilot with exit interviews. Baseline and post intervention assessments will include self-reported measures including relationship satisfaction, wellbeing, and caregiver stress. The research team will engage in behavioral observation coding to assess active engagement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Informal caregiver (specifically, a family member) of a person with moderate-severe dementia and person with moderate-severe dementia
- •Moderate to severe as determined by Functional Assessment Staging Tool (FAST Scale) taken by caregiver
- •Age 18 or older
- •English-speaking
- •Willing and able to use the platform together 3-4 times a week for 20-30 minutes
- •Located in the Boston area
排除标准
- •Lack of access to internet and/or a computer with a camera
- •Untreated serious mental illness and or substance use diagnosis
结局指标
主要结局
Engagement
时间窗: 4 weeks
The investigators will examine whether the Isle of TEND is able to capture engagement among participants. Participants will complete the User Engagement Scale after each platform use to report engagement. The User Engagement Scale is on a scale of 1 (Strongly disagree) to 5 (Strongly agree) with higher scores indicating greater engagement. Participants can score between 3 and 15.
Adherence
时间窗: 4 weeks
The investigators will measure adherence through objective and self report measures. Participants will log in a journal each time and duration they use the platform. Additionally, the website platform will run diagnostics to report aggregated use across all participants.
次要结局
- Depression(4 weeks)
- Caregiver stress(4 weeks)
- Relationship Satisfaction(4 weeks)
研究者
Christine S. Ritchie, MD, MPH
Director of Research, Division of Palliative Care and Geriatric Medicine
Massachusetts General Hospital