A Cluster Randomized Trial of a Telemedicine-Enabled Integrated Care Model for Stroke Prevention and Management in Rural Elderly Adults in China

May 28, 2026 updated by: Jiangsu Province (Suqian) Hospital

A Prospective, Open-Label, Cluster Randomized Controlled Trial to Evaluate the Efficacy of a Rural Doctor-Led, Telemedicine-Supported Integrated Care Model for Reducing Cardiovascular and Cerebrovascular Events in Elderly Adults at High Risk of Stroke in China

This cluster randomized controlled trial aims to evaluate the effectiveness of a novel telemedicine-enabled integrated care model led by rural doctors in reducing cardiovascular and cerebrovascular events among elderly adults (≥65 years) at high risk of stroke in rural China. A total of 39 village clinics will be randomized to either the intervention group (digital health platform-supported integrated care) or the control group (enhanced usual care). The primary outcome is a composite of cardiovascular death, stroke, and hospitalization for heart failure or acute coronary syndrome at 36 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Stroke is the leading cause of death and disability in China, with a disproportionately higher burden in rural areas. This study proposes a "technology-enabled, vertically integrated, pathway-integrated, performance-incentivized" care model to address the gaps in rural stroke management. The intervention group will use a dedicated digital health platform (https://ricestroke.sqfh.org.cn:8421/gp/#/login) that provides clinical decision support, remote consultation with specialists, patient follow-up reminders, and performance feedback for rural doctors. The control group will receive enhanced usual care without the digital platform. The study will enroll 2510 participants and follow them for 36 months to assess the impact of the intervention on clinical outcomes, risk factor control, and medication adherence.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2510

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Liu Qianghui Director of Suqian Hospital, Jiangsu Provincial People's Hospi
  • Phone Number: 15951598055
  • Email: jasonlion815@163.com

Study Locations

  • China
    • Jiangsu
      • Suqian, Jiangsu, China
        • Suqian Hospital Affiliated to Jiangsu Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 65 years or older
  2. Rural residents with household registration or long-term residence (≥6 months/year) in the study area
  3. High risk of stroke as defined by the National Health Commission's "8+2" stroke risk screening tool: ≥3 risk factors OR history of stroke/TIA
  4. Willing to receive long-term health management from the assigned village clinic
  5. Written informed consent provided by the participant or their legal representative

Exclusion Criteria:

  1. Severe dementia or psychiatric disorder that prevents completion of study follow-up and assessments
  2. Life expectancy less than 1 year (e.g., advanced malignancy, end-stage renal disease)
  3. Currently participating in another interventional clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Telemedicine-Enabled Integrated Care Group
Participants receive care from rural doctors using a dedicated digital health support platform, including monthly monitoring, personalized medication adjustment, remote specialist consultation, and structured patient education.
Behavioral: Digital Health Platform-Supported Integrated Stroke Management
Patient electronic health record management AI-powered clinical decision support for medication adjustment based on Chinese stroke guidelines Weekly remote video consultation with neurologists from tertiary hospitals Automated follow-up and medication adherence reminders Structured education and training for both rural doctors and patients
Active Comparator: Enhanced Usual Care Group
Participants receive enhanced usual care from rural doctors who have received standardized training on stroke prevention and management, without the use of the digital health platform.
Behavioral: Enhanced Usual Stroke Care
Rural doctors provide monthly face-to-face care based on national guidelines, including symptom monitoring, blood pressure measurement, medication guidance, and patient education. Referrals to tertiary hospitals are made through conventional channels.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite of Cardiovascular Death, Stroke, and Hospitalization for Heart Failure or Acute Coronary Syndrome at 36 Months
Time Frame: 36 months
The primary composite endpoint includes: (1) cardiovascular death; (2) first occurrence of stroke (ischemic, hemorrhagic, or undetermined type); (3) hospitalization for worsening heart failure or acute coronary syndrome. All events will be adjudicated by an independent clinical events committee blinded to treatment assignment.
36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
First Recurrent Stroke Event Rate at 36 Months
Time Frame: 36 months
Time to first recurrent stroke (ischemic, hemorrhagic, or undetermined type) confirmed by CT/MRI imaging
36 months
All-Cause Mortality at 36 Months
Time Frame: 36 months
Death from any cause
36 months
Cardiovascular-Specific Mortality at 36 Months
Time Frame: 36 months
Death due to cardiovascular causes including sudden cardiac death, myocardial infarction, heart failure, and stroke
36 months
Hospitalization for Heart Failure or Acute Coronary Syndrome at 36 Months
Time Frame: 36 months
Number of participants hospitalized for worsening heart failure or acute coronary syndrome
36 months
Major Bleeding Events (ISTH Criteria) at 36 Months
Time Frame: 36 months
Number of participants experiencing major bleeding events as defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria
36 months
Change in CHINA-PAR Score from Baseline to Month 12
Time Frame: Baseline, Month 12
Change in 10-year ASCVD risk percentage as calculated by the CHINA-PAR risk prediction model in participants without prior stroke history
Baseline, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Province (Suqian) Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RICE-STROKE-2026-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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