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

NCT ID: NCT07151430

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

358 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-12-01

Brief Summary

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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

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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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental Arm

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

Group Type EXPERIMENTAL

Service Package Group

Intervention Type DEVICE

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

Control Arm

Standard of care without the service package.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Service Package Group

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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yinchunlin

Director of Department of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yin Chun Lin, PhD

Role: CONTACT

8613552566227

Other Identifiers

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2023YFC3605003

Identifier Type: OTHER

Identifier Source: secondary_id

XWH-MULTICOMORB-2024-001

Identifier Type: -

Identifier Source: org_study_id

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