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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Behavioral: SINEMA intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The SINEMA model, cognizant of health system's organization around primary, secondary and tertiary healthcare 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 (in the form of an Android-based SINEMA APP for village doctors and cellphone voice messages for participants). The overarching aim is to strengthen the capacity of village doctors on delivering services for the secondary prevention of stroke and promoting medication adherence and physical activity among stroke survivors.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SINEMA intervention group<br>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<br>* 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.<br>|
| No Intervention: Control group<br>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 | change in systolic blood pressure | change from baseline to 12-month of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mobility | 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 | 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 | 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 | measured using EuroQol-5 Dimensions-5L (EQ5D) | change from baseline to 12-month of follow-up | 
| diastolic blood pressure | participants' diastolic blood pressure | change from baseline to 12-month of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
secondary prevention, primary healthcare, village doctors, rural China, medication adherence, physical activity