Evaluating the Effectiveness of an Online Small-Group Self-Management Workshop for Rural Caregivers of Individuals With Alzheimer's Disease and Related Dementias
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 418
- 试验地点
- 2
- 主要终点
- Personal Health Questionnaire Depression (PHQ-8) Scale Score
研究概览
简要总结
Rural caregivers face challenges of geographic isolation and lower health care access and quality. Many rural dementia caregivers experience serious health consequences due to caregiving responsibilities that can limit their ability to maintain their caregiving role. Thus, there is a pressing need for effective, scalable, and accessible programs to support rural dementia caregivers.
Online programs offer a convenient and readily translatable option for program delivery because they can be accessed by caregivers in the home and at the convenience of the user. Building Better Caregivers is an online 6-week, interactive, small-group self-management, social support, and skills-building workshop developed for caregivers of individuals with Alzheimer's disease or related dementia.
The investigators will conduct a hybrid effectiveness-implementation randomized controlled trial that will enroll and randomize 640 rural dementia caregivers into two groups: the intervention (workshop) group and the attention control group. Caregivers will be recruited throughout the United States. Primary outcomes will be caregiver stress and depressive symptoms. The investigators hypothesize that stress scores and depressive symptoms will be significantly improved at 12 months in the intervention group versus control group. The investigators will also identify key strengths (facilitators) and weaknesses (barriers) of workshop implementation. The investigators will use the RE-AIM implementation framework and a mixed methods approach to identify implementation characteristics pertinent to both caregivers and rural community organizations.
If the Building Better Caregivers workshop is proven to be effective, this research has the potential to open new research horizons, particularly on how to reach and effectively support isolated dementia caregivers in rural areas with an intervention that is scalable, even in low-resourced settings. If the workshop can achieve its goals with rural dementia caregivers, some of those most isolated, it would also be expected to be scalable in other low-resourced settings (e.g., in urban or suburban environments).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, 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
- •Aged 18 years or older
- •Caring for person with dementia
- •Able to read and write in English
- •Able to access the internet
- •Providing care for ≥ 10 hours per week
- •Reporting a minimum stress level of 4 or more on a 10-point scale
- •Living in rural area of United States (self-identify or zip code is a Rural Urban Commuting Area Codes (RUCA) defined rural area)
排除标准
- •Have an anticipated inability to complete the 12-month follow-up (e.g., planned travel)
结局指标
主要结局
Personal Health Questionnaire Depression (PHQ-8) Scale Score
时间窗: 12 months
Personal Health Questionnaire Depression (PHQ-8) scale. The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating worse outcome.
Visual Numeric Stress Scale
时间窗: 12 months
A visual numeric stress scale. The scale score ranges from 0 to 10, with higher score indicating worse outcome.
次要结局
- Personal Health Questionnaire Depression (PHQ-8) Scale Score(6 months)
- Visual Numeric Stress Scale Score(6 months)
- Short Caregiver Self-Efficacy Scale Score(12 months)
- Zarit Burden Interview-12 (ZBI-12) Scale Score(12 months)
- Caregiver Self-rated General Health Score(12 months)
- UCLA Loneliness Scale Score(12 months)
- Lubben Social Isolation Scale Score(12 months)
- Caregiver Health Care Utilization(12 months)
- Person With Dementia General Health Score as Reported by Caregiver(12 months)