Impact Evaluation of the Digital Connect Project for Homebound Older Adults: A Target Trial Emulation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,024
- 试验地点
- 1
- 主要终点
- Cognitive function score
研究概览
简要总结
The goal of this study is to evaluate the impact of the Digital Connect Project on increasing functional capacity defined by the WHO-ICOPE and health-related quality of life (HRQL) among homebound older adults.
详细描述
The Hong Kong Jockey Club Charities Trust is launching the Digital Connect project to increase the well-being and social connectedness of the homebound older adults. A total of 32 NGOs are applying for 7,500 tablets and data plan (in total) through this project. Different digital programs will be rolled out to enhance their well-being and social connectedness. This study aim is to capture the impact of this Digital Connect project on the health outcomes of the homebound older adults. The tablet intervention will be offered by the NGOs within a 2-year timeframe. Web-based multi-domain lifestyle training intervention will be conducted to promoted and focus three lifestyles: nutritional advice, exercise and cognitive training; chat communication with research team, and personalized agenda on daily activities and an information library.
The object of this study is to explore the dose-response relationship between online engagement in the different types of activity and the improvement in the corresponding health outcomes, including the five domains: (1) Physical function, (2) Cognitive function, (3) Psychological function, (4) Social function and (5) Health-related quality of life. One baseline assessment and four follow-ups will be arranged in every 3-month interval. To account for immortal time bias, each subject will be created with two clones at time zero and assigned each of the two clones to either treatment or control group, respectively.
The engagement experience will be explored by interviewing the participants and service stakeholders through the planning and delivery of the digital intervention for the homebound older adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 65
- •consent to participate
- •able to participate in the impact assessment as evidence by a test score of > 6 on the Abbreviated Mental Test
- •has the functional ability to engage in the digital intervention
排除标准
- 未提供
研究组 & 干预措施
Treatment status
To account for immortal time bias, each subject will be created with two clones at time zero and assigned each of the two clones to either treatment or no-treatment status, respectively. The treatment status in each evaluative endpoint (i.e., 3-month, 6-month, and 12-month) is defined as subjects who have received the digital intervention for the respective length of time since the time zero during which the intervention has just commenced.
干预措施: Digital intervention through Tablet (Behavioral)
No-treatment status
To account for immortal time bias, each subject will be created with two clones at time zero and assigned each of the two clones to either treatment or no-treatment status, respectively. The corresponding no-treatment status is defined as subjects who have not received the digital intervention for the corresponding length of time.
干预措施: Digital intervention through Tablet (Behavioral)
结局指标
主要结局
Cognitive function score
时间窗: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
Measured by 5-minute Montreal Cognitive Assessment (MoCA) (range from 0 to 30), A score of 26 or over is considered to be normal.
Health-related quality of life (HRQL)
时间窗: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
Measure by EQ-5D-5L (range from -0.59 to 1.0), higher score indicates better quality of life
Physical function
时间窗: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
Measured by Short Physical Performance Battery (range from 0 to 12), with higher score indicating better physical performance
Loneliness score
时间窗: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
Measured by 3-item UCLA Loneliness Scale (range 3-9), higher score indicates greater loneliness.
Depression score
时间窗: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
Measured by The 8-item Geriatric Depression Scale (range 0 to 8), with higher score indicating higher risk of depression
Social function
时间窗: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
Measured by 8-item Social Connectedness Scale Revised (range 0 to 48), \<22 indicates lack of social connectedness
Subjective Memory Score
时间窗: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
Measured by 7-item Memory Complaint Scale (MCS) (range from 0 to 14), lower score indicates better memory performance. No MCs (0-2), Mild MCs (3-6), Moderate MCs (7-10), Severe MCs (11-14).
次要结局
未报告次要终点
研究者
Prof. Yu, Doris Sau Fung
Professor
The University of Hong Kong