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

Last updated: September 15, 2020
Sponsor: Duke Kunshan University
Overall Status: Completed

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT03185858
2015MRC0012
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria: those who

  • are aged more than 18 years old;

  • have a history of stroke (including ischemic and hemorrhagic stroke) diagnosed atcounty hospital or higher-level facilities, and currently in a clinically stablecondition 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

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 Design

Total Participants: 1299
Study Start date:
June 23, 2017
Estimated Completion Date:
December 31, 2019

Study 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.

Connect with a study center

  • Nanhe County

    Xingtai, Hebei 054400
    China

    Site Not Available

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