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NCT number NCT03185858
Study type Interventional
Source Duke Kunshan University
Contact Wanbing Gu, Msc.
Phone (+86) 0512 36657242
Email wanbing.gu@dukekunshan.edu.cn
Status Not yet recruiting
Phase N/A
Start date June 2017
Completion date December 2018

Clinical Trial Summary

The aim of the study is to evaluate the effectiveness the SINEMA model via a one-year cluster randomized controlled trial in a resource-poor rural area in China. The hypothesis is that trained village doctors (VDs) and family caregivers, equipped with digital health technology, can provide essential evidence-based care to stroke survivors in rural China.


Clinical Trial Description

Background

Stroke imposes major societal and economic burdens and is one of the leading causes of death and disability in rural China. Stroke survivors suffer from high risk of recurrence with particularly high rates reported for China, signifying the importance of secondary prevention of stroke. Although improving the quality of stroke care has become a national priority since 2009, post-acute secondary prevention and rehabilitation are largely unavailable in rural China and where present are far below evidence-based standard.

SINEMA model

We propose a system-integrated technology-enabled model of care (SINEMA) model. The model, cognizant of health system's organization around tertiary, secondary, and primary levels in China, adopts the principles of cascade training with feedback and task-sharing, and relies on existing human resources available at the community level. It also proposes the use of innovative mobile technology as tools (Android-based smartphone application for VDs and text/voice messages for patients), with the overarching aim of providing evidence-based and essential patient management focusing on medication adherence and physical activity.

Study design

The SINEMA model will be implemented in Nanhe County, China and be evaluated through a cluster-randomized control trial. Fifty villages with about 25 stroke patients per village will be recruited. After a baseline survey, these villages will be randomized in a 1:1 ratio to either the intervention group (SINEMA model) or the control group (usual care). Follow-up survey will be conducted in the same way in all villages at 3-month and 12-month after the initial of the study. The primary outcome is systolic blood pressure and a number of secondary and exploratory outcomes will be collected. Process evaluation and economic evaluation will also be conducted.


Study Design


Related Conditions & MeSH terms


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