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

Duke Kunshan University

Status: Completed

Conditions: Stroke

Treatments: Behavioral: SINEMA intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03185858

2015MRC0012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,299 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,299 participants in 2 patient groups

SINEMA intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: SINEMA intervention

Control group

No Intervention group

Description:

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.