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Not yet recruiting NCT07151430

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

No phase Interventional Multimorbidity Hypertension Diabetes Mellitus Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Service Package Group.
Who it may be relevant to
Registry conditions: Multimorbidity, Hypertension, Diabetes Mellitus, Coronary Artery Disease. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Development and Validation of a Comprehensive Management Service Package for Older Adults With Multimorbidity: A Randomized Controlled Trial

Overview

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

Interventions

  • Device Service Package Group
    patients receive comprehensive multimorbidity management service package (digital tools, MDT decision support, lifestyle interventions, long-term management tools).

Primary outcome measures

  • Hospital readmission rate [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07151430 · XWH-MULTICOMORB-2024-001 · 2023YFC3605003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗