Development and Validation of a Comprehensive Management Service Package for Older Adults With Multimorbidity

Not Applicable

Not yet recruiting

• Conditions: Multimorbidity; Hypertension; Diabetes Mellitus; Coronary Artery Disease; Dyslipidemia; Stroke; Arthritis; Cognitive Impairment; Depression - Major Depressive Disorder; Chronic Kidney Disease

• Registration Number: NCT07151430
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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.

Detailed Description

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:

1. Does the service package lower the number of hospital readmissions in older adults with multimorbidity?

2. Does it improve quality of life, daily function (intrinsic capacity), and treatment adherence?

3. 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:

1. Be randomly assigned to either the service package group or the usual care group

2. Use the digital tools and health management support included in the service package (such as apps, monitoring devices, and personalized health guidance)

3. Receive regular follow-up visits and surveys over 6 months to track their health, hospital use, and satisfaction

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-19
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03
• Study Start: 2025-12-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 358

Inclusion Criteria

1. Age ≥65 years
2. Diagnosed with ≥2 chronic diseases or geriatric syndromes (e.g., hypertension, diabetes, frailty, depression)
3. Willing to provide informed consent

Exclusion Criteria

1. Life expectancy <1 year due to severe illness (e.g., cardiogenic shock)
2. Currently participating in other clinical trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hospital readmission rate	6 months	Hospital readmission rate