Development and Validation of a Comprehensive Management Service Package for Older Adults With Multimorbidity: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 358
- 主要终点
- Hospital readmission rate
研究概览
简要总结
This study aims to test a new comprehensive management service package for older adults with two or more chronic conditions (multimorbidity). The package includes digital health tools, personalized guidance, and long-term management support. Researchers will compare the service package with usual care to see whether it reduces hospital readmissions, improves quality of life, and supports daily functioning. About 394 participants will be randomly assigned to either the service package group or the usual care group. Participants will be followed for 6 months to measure health outcomes, treatment adherence, and safety.
详细描述
The goal of this clinical trial is to learn if a new comprehensive management service package can help improve health outcomes for older adults who have two or more chronic conditions (multimorbidity). It will also learn about the safety, acceptability, and cost-effectiveness of the service package.
The main questions it aims to answer are:
- Does the service package lower the number of hospital readmissions in older adults with multimorbidity?
- Does it improve quality of life, daily function (intrinsic capacity), and treatment adherence?
- What are the costs and potential risks of using the service package compared to usual care? Researchers will compare the service package to usual care (no service package).
Participants will:
- Be randomly assigned to either the service package group or the usual care group
- Use the digital tools and health management support included in the service package (such as apps, monitoring devices, and personalized health guidance)
- Receive regular follow-up visits and surveys over 6 months to track their health, hospital use, and satisfaction
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 (Outcomes Assessor)
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 years
- •Diagnosed with ≥2 chronic diseases or geriatric syndromes (e.g., hypertension, diabetes, frailty, depression)
- •Willing to provide informed consent
排除标准
- •Life expectancy <1 year due to severe illness (e.g., cardiogenic shock)
- •Currently participating in other clinical trials
研究组 & 干预措施
Experimental Arm
Comprehensive multimorbidity management service package (digital tools, MDT decision support, lifestyle interventions, long-term management tools).
干预措施: Service Package Group (Device)
Control Arm
Standard of care without the service package.
结局指标
主要结局
Hospital readmission rate
时间窗: 6 months
Hospital readmission rate
次要结局
未报告次要终点
研究者
yinchunlin
Director of Department of Cardiology
Xuanwu Hospital, Beijing