SINEMA Model of Care to Improve the Health of Stroke Patients in Rural China (SINEMA)

September 15, 2020 updated by: Duke Kunshan University

System-integrated Technology-enabled Model of Care to Improve the Health of Stroke Patients in Rural China

Despite the significant burden of stroke in rural China, secondary prevention of stroke is scarce. The aim of the study is to develop a system-integrated technology-enabled intervention (SINEMA) model for the secondary prevention of stroke in rural China and evaluate the effectiveness of the model compared with usual care. The hypothesis is that trained village doctors, equipped with digital health technology, can provide essential evidence-based care to stroke survivors in rural China.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The SINEMA trial is a cluster-randomized controlled trial to evaluate the effectiveness of implementation of a system-integrated and technology-enabled model of care to improve the secondary prevention of stroke in Nanhe County, a rural area of Hebei province, China. Fifty villages from five townships are stratified randomized in a 1:1 ratio to either the intervention arm (implementing SINEMA model) or the control arm (usual care).

After a baseline survey, intervention will be implemented in 25 intervention villages, lasting for 12 months. Follow-up survey will be conducted in the same way in all villages at 12-month after the initial of the study. Process evaluation will be conducted every three month, and economic evaluation will also be conducted.

Study Type

Interventional

Enrollment (Actual)

1299

Phase

  • 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 Locations

  • China
    • Hebei
      • Xingtai, Hebei, China, 054400
        • Nanhe County

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: those who

  • are aged more than 18 years old;
  • have a history of stroke (including ischemic and hemorrhagic stroke) diagnosed at county hospital or higher-level facilities, and currently in a clinically stable condition and not receiving acute stroke treatment;
  • will live in this village for at least nine months during the next 12 months;
  • have a basic communication ability (i.e. can understand simple instructions);
  • give participant informed consent and are willing to participate in the study.

Exclusion Criteria: those who

  • are unable to get out of bed without maximum assistance;
  • have serious life-threatening disease such as cancers;
  • who have an expected life span of less than 6 months.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SINEMA intervention group
The intervention arm will implement the SINEMA model for one year, which consists of a provider-facing intervention aiming to strengthen the capacity of village doctors in delivering stroke secondary prevention, and a stroke survivor-facing intervention aiming to promote medication adherence and physical activity.
Behavioral: SINEMA intervention

Provider-facing intervention includes the following components:

(1) Systematic cascade training for village doctors; (2) monthly follow-up visits with the support of the SINEMA APP; (3) village doctor group activities; (4) performance feedback and incentives.

Stroke survivor-facing intervention program includes the following components:

(1) Briefing session; (2) monthly follow-up visits and follow-up handout; (3) daily voice message for health education.
No Intervention: Control group
Villages in the control arm continue their usual practice without the introduction of any of the SINEMA activities described above. People who have hypertension or who are at high-risk of hypertension may receive follow-up visits four times per year as part of the basic public health services required by the government.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
systolic blood pressure
Time Frame: change from baseline to 12-month of follow-up
change in systolic blood pressure
change from baseline to 12-month of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mobility
Time Frame: change from baseline to 12-month of follow-up
measured by timed-up-and-go test, a simple and quick functional mobility test that requires the participants to stand up, walk 3 meters, turn, walk back, and sit down
change from baseline to 12-month of follow-up
medication adherence
Time Frame: change from baseline to 12-month of follow-up
measured using 4 item Morisky Green Levine Scale-4 (MMAS-4), which scores adherence from 0-4 and continuation of medication taking is measured by the total months of medication taking
change from baseline to 12-month of follow-up
physical activity level
Time Frame: change from baseline to 12-month of follow-up
measured using the short version of the International Physical Activity Questionnaire(IPAQ)
change from baseline to 12-month of follow-up
health related quality of life
Time Frame: change from baseline to 12-month of follow-up
measured using EuroQol-5 Dimensions-5L (EQ5D)
change from baseline to 12-month of follow-up
diastolic blood pressure
Time Frame: change from baseline to 12-month of follow-up
participants' diastolic blood pressure
change from baseline to 12-month of follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
stroke recurrence and hospitalization
Time Frame: at the end of the intervention (12-month)
will be collected through questionnaire and medical insurance records
at the end of the intervention (12-month)
disability
Time Frame: at the end of the intervention (12-month)
measured using modified Rankin Scale (ranged 0 (no symptom) to 5 severe disability)
at the end of the intervention (12-month)
Stroke related mortality
Time Frame: at the end of the intervention (12-month)
will be collected through questionnaire, medical insurance records and verbal autopsy
at the end of the intervention (12-month)

Collaborators and Investigators

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

Sponsor

Duke Kunshan University

Collaborators

Beijing Tiantan Hospital
Duke University
Medical Research Council
Wellcome Trust
Department for International Development, United Kingdom
Centers for Disease Control and Prevention, China
Economic and Social Research Council, United Kingdom
China Mobile Research Institute
Xingtai Center for Disease Control and Prevention, China

Investigators

  • Principal Investigator: Lijing L. Yan, PhD, Duke Kunshan Unviersity

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 (Actual)

June 23, 2017

Primary Completion (Actual)

July 31, 2018

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

June 12, 2017

First Posted (Actual)

June 14, 2017

Study Record Updates

Last Update Posted (Actual)

September 17, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015MRC0012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The investigators will not share the individual participant data. But other researchers could contact PI if there is special inquiry.

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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