MultimorbidityCOMPASSNCT07151430
Development and Validation of a Comprehensive Management Service Package for Older Adults With Multimorbidity
A study testing Service Package Group in people with Multimorbidity and Hypertension, run by Xuanwu Hospital, Beijing.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multimorbidity, Hypertension, Diabetes Mellitus
- What is being tested?
- Service Package Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥65 years
- Diagnosed with ≥2 chronic diseases or geriatric syndromes (e.g., hypertension, diabetes, frailty, depression)
- Willing to provide informed consent
Who cannot join
- Life expectancy <1 year due to severe illness (e.g., cardiogenic shock)
- Currently participating in other clinical trials
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development and Validation of a Comprehensive Management Service Package for Older Adults With Multimorbidity: A Randomized Controlled Trial
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.
Read the 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:
- 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
- Conditions
- Multimorbidity, Hypertension, Diabetes Mellitus, Coronary Artery Disease, Dyslipidemia, Stroke
- Being tested
- Service Package Group
- Keywords
- management service package, multimorbidity, quality of life, intrinsic capacity
- Medical subject headings
- Hypertension, Diabetes Mellitus, Coronary Artery Disease, Dyslipidemias, Stroke, Arthritis, Cognitive Dysfunction, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Service Package GroupDevice
patients receive comprehensive multimorbidity management service package (digital tools, MDT decision support, lifestyle interventions, long-term management tools).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Comprehensive multimorbidity management service package (digital tools, MDT decision support, lifestyle interventions, long-term management tools). Receives: Device: Service Package Group |
| Control Arm | No intervention | Standard of care without the service package. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital readmission rate
Hospital readmission rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MultimorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yinchunlin, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151430
- Sponsor's protocol ID
- XWH-MULTICOMORB-2024-001
- Other IDs
- 2023YFC3605003
- Acronym
- COMPASS
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Comprehensive Management Service Package for Older Adults With Multimorbidity: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07151430
- Acronym / sponsor ID
- COMPASS / XWH-MULTICOMORB-2024-001
- Conditions
- Multimorbidity, Hypertension, Diabetes Mellitus, Coronary Artery Disease, Dyslipidemia, Stroke
- Keywords
- management service package, multimorbidity, quality of life, intrinsic capacity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Device: Service Package GroupComprehensive multimorbidity management service package (digital tools, MDT decision support, lifestyle interventions, long-term management tools). |
| Control Arm | No intervention | –Standard of care without the service package. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥65 years
- Diagnosed with ≥2 chronic diseases or geriatric syndromes (e.g., hypertension, diabetes, frailty, depression)
- Willing to provide informed consent
Key exclusion criteria (2 listed)
- Life expectancy <1 year due to severe illness (e.g., cardiogenic shock)
- Currently participating in other clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Service Package Grouppatients receive comprehensive multimorbidity management service package (digital tools, MDT decision support, lifestyle interventions, long-term management tools). | Device | Experimental Arm |
Primary outcome
Hospital readmission rate
Time frame: 6 months
Hospital readmission rate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Service Package Group in people with Multimorbidity and Hypertension, run by Xuanwu Hospital, Beijing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yin Chun Lin, PhD (8613552566227, yinclmail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital readmission rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.