WECARE: A Personalized Intervention for High-Demand Dementia Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Efficacy of Behavioral Intervention in Change From Baseline in Depressive Symptoms
研究概览
简要总结
The goal of the project is to evaluate Wellness Enhancement for Caregivers (WECARE), a digital behavioral intervention for high-demand dementia caregivers. The behavioral intervention is culturally tailored to the target users and will be delivered via the WECARE mobile app and accompanying website, accessible only to verified enrolled participants. Participants will engage with digital learning materials and supportive resources over the course of the program. The goal is to determine whether this approach improves caregiver well-being and reduces stress related to caregiving.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •currently residing in the United States,
- •are 21 years of age or older,
- •own a smartphone or computer, AND
- •currently care for a family member or loved one who lives of Alzheimer's disease or related dementia and meet one of hte following high-demand criteria:
- •age 65 or older,
- •provide 10 or more hours of direct care per week,
- •work 20 or more hours per week in addition to caregiving,
- •care for another family member (e.g., a child under 18, another parent, or a spouse); or
- •experience difficulty covering basic living expenses.
排除标准
- •evidence or signs of severe cognitive impairment or mental disorders,
- •the care recipient was receiving hospice care or had a life expectancy of fewer than six months, OR
- •Unable to provide informed consent
研究组 & 干预措施
Intervention group
Participants will first complete a baseline survey online, then access the WECARE program via a project-specific mobile app (WECARE) or its accompanying website and begin receiving the 7-week interactive and personalized program. The program content includes short video clips, pictorial messages, and audio recordings. Each week, the WECARE program is focused on a theme aimed to increase participants' caregiving mastery, enhance self-care, and improve psychosocial wellbeing. Four weeks after the intervention or 11 weeks after the baseline, participants will complete the follow-up survey online. Six months after the baseline, participants will complete the second follow-up survey online. Tweleve months after the baseline, participants will complete the third follow-up survey online.
干预措施: WECARE (Behavioral)
Control Group
Participants in this arm will receive equal attention intervention. They will also access the WECARE app and accomanying website to receive the 7-week program featured in general health education. Each week, participants receive health information with a focused theme at the same frequency as the intervention group. Four weeks after the intervention or 11 weeks after the baseline, participants will complete the first follow-up survey online. Six months after the baseline, participants will complete the second follow-up survey online. Tweleve months after the baseline, participants will complete the third follow-up survey online.
干预措施: Equal-attention comparator (Behavioral)
结局指标
主要结局
Efficacy of Behavioral Intervention in Change From Baseline in Depressive Symptoms
时间窗: Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
The baseline and follow-up differences in depressive symptoms will be assessed using the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D is a 20-item survey instrument designed to measure the frequency and severity of depressive symptoms. The total score is calculated by summing the responses to all 20 items. The total scale ranges from 0 to 60, with higher scores indicating more severe depressive symptoms (a worse outcome). The primary analysis will calculate the difference in this total score between baseline and follow-up. adults and dementia caregivers.
次要结局
- Efficacy of Behavioral Intervention in Change From Baseline in Caregiving Burden(Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention))
研究者
Y. Alicia Hong
Professor
George Mason University