Translating a Dementia Caregiver Intervention Into a Mobile Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Timing of Assessments
研究概览
简要总结
The overall goal of this development project is to combine elements of two efficacious interventions into a mobile health (mHealth) App for informal dementia caregivers. The investigators will conduct a 3-month feasibility trial of the newly-developed CARE-Well App in 40 dementia caregivers to establish acceptability and feasibility of the intervention, study procedures, and outcome measures.
详细描述
Caring for a person with dementia is a highly stressful activity and is associated with negative physical and mental health consequences, including increased risk of depression and worse reported health-related quality of life. The proposed project aims to develop and translate an evidence-based, multi-component intervention into a mHealth App that has the potential to increase dementia caregivers' access to support and care.
The investigators will conduct a feasibility trial, in which 40 dementia caregivers will be randomized to receive a computer tablet preloaded with the CARE-well App or preloaded with internet links relevant to dementia and caregiving. Paper outcome measures will be assessed at baseline and end of intervention (3 months) during each study visit. To measure sustainability of the App, the first 10 caregivers from each group will be offered the tablets for an additional month to monitor usage of the App outside the formal trial. The goal of this aim is to determine feasibility of the intervention, study procedures, and outcome measures.
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
- Single (Outcomes Assessor)
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
- •Adequate English-speaking and reading skills
- •Provide at least 4 hours of supervision per day for the care recipient (either directly or by telephone)
- •Live in the community (either with the care recipient or without)
- •Have provided supervision/ assistance for at least 6 months prior to study enrollment and have no plans to place care recipient in long term care or to end their role as caregiver within 6 months of study enrollment.
- •Report some degree of distress associated with caregiving
- •Access to Wifi at home
排除标准
- •Major acute medical illness
- •Severe mental illness (e.g. bipolar, schizophrenia)
- •Diagnosed cognitive impairment
结局指标
主要结局
Timing of Assessments
时间窗: 3 months
Percentage of participants who completed assessments at baseline and follow-up within two weeks of enrollment or completion of the study.
Interest in Continuation of Tablet/App Use After Formal Trial
时间窗: 3 months
Percentage of participants in a subset of caregivers (10 from each group) interested in continuing to use tablet/App use after formal trial as an estimate of sustainability.
Randomization
时间窗: 3 months
Percentage of participants who decline participation because of randomization.
App Technology Satisfaction
时间窗: 3 months
Percentage of participants satisfied or very satisfied with App technology.
Study Enrollment Rate and Retention
时间窗: 3 months
Percentage of participants enrolled and who remain enrolled for the duration of the study.
Intervention Adherence
时间窗: 3 months
Percentage of participants who used the internet links or the app for the 3-month intervention period.
Completion Rates
时间窗: 3 months
Percentage of participants who completed the intervention.
App Content Satisfaction
时间窗: 3 months
Percentage of participants satisfied or very satisfied with App content.
次要结局
- Desire to Institutionalize Scale(Baseline and immediately Post-Intervention at 3 months)
- Center for Epidemiologic Studies Depression Scale(Baseline and immediately Post-Intervention at 3 months)
- Zarit Burden Interview(Baseline and immediately Post-Intervention at 3 months)
- Revised Memory and Behavior Problem Checklist(Baseline and immediately Post-Intervention at 3 months)
研究者
Geoffrey Tremont
Director of Neuropsychology
Rhode Island Hospital