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

Active, not recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • SINEMA intervention Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: SINEMA intervention group
    Description: Stroke patients in the intervention group will receive SINMEA model intervention lasting for a year.

Outcomes

Type Measure Time Frame Safety Issue
Primary systolic blood pressure change from baseline to 12-month of follow-up
Secondary medication adherence change from baseline to 12-month of follow-up
Secondary mobility measured by timed-up-and-go test change from baseline to 12-month of follow-up
Secondary health related quality of life change from baseline to 12-month of follow-up
Secondary mobility change from baseline to 12-month of follow-up
Secondary physical activity level change from baseline to 12-month of follow-up

Sponsors