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

Capital Medical University

Status: Not yet enrolling

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

Treatments: Device: Service Package Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07151430

XWH-MULTICOMORB-2024-001

2023YFC3605003 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 358 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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358 participants in 2 patient groups

Experimental Arm

Experimental group

Description:

Comprehensive multimorbidity management service package (digital tools, MDT decision support, lifestyle interventions, long-term management tools).

Treatment:

Device: Service Package Group

Control Arm

No Intervention group

Description:

Standard of care without the service package.