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Completed

NCT Number: NCT03185858

SINEMA 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SINEMA intervention

Behavioral

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.

Primary outcomes

  1. systolic blood pressure

    Time frame: change from baseline to 12-month of follow-up

    change in systolic blood pressure

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. health related quality of life

    Time frame: change from baseline to 12-month of follow-up

    measured using EuroQol-5 Dimensions-5L (EQ5D)

  5. diastolic blood pressure

    Time frame: change from baseline to 12-month of follow-up

    participants' diastolic blood pressure

Other outcomes

  1. stroke recurrence and hospitalization

    Time frame: at the end of the intervention (12-month)

    will be collected through questionnaire and medical insurance records

  2. disability

    Time frame: at the end of the intervention (12-month)

    measured using modified Rankin Scale (ranged 0 (no symptom) to 5 severe disability)

  3. Stroke related mortality

    Time frame: at the end of the intervention (12-month)

    will be collected through questionnaire, medical insurance records and verbal autopsy

Sponsors and collaborators

Lead sponsor

Duke Kunshan University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SINEMA

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 14, 2017
Registry last updated
Sep 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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