System-integrated technology-enabled model of care to improve the health of stroke patients in rural China: protocol for SINEMA-a cluster-randomized controlled trial

Abstract

Background: Despite the significant burden of stroke in rural China, secondary prevention of stroke is suboptimal. This study aims to develop a SINEMA for the secondary prevention of stroke in rural China and to evaluate the effectiveness of the model compared with usual care.

Methods: The SINEMA model is being implemented and evaluated through a 1-year cluster-randomized controlled trial in Nanhe County, Hebei Province in China. Fifty villages from 5 townships are randomized in a 1:1 ratio to either the intervention or the control arm (usual care) with a target to enroll 25 stroke survivors per village. Village doctors in the intervention arm (1) receive systematic cascade training by stroke specialists on clinical guidelines, essential medicines and behavior change; (2) conduct monthly follow-up visits with the support of a mobile phone application designed for this study; (3) participate in virtual group activities with other village doctors; 4) receive performance feedback and payment. Stroke survivors participate in a health education and project briefing session, receive monthly follow-up visits by village doctors and receive a voice message call daily as reminders for medication use and physical activities. Baseline and 1-year follow-up survey will be conducted in all villages by trained staff who are blinded of the randomized allocation of villages. The primary outcome will be systolic blood pressure and the secondary outcomes will include diastolic blood pressure, medication adherence, mobility, physical activity level and quality of life. Process and economic evaluation will also be conducted.

Discussion: This study is one of very few that aim to promote secondary prevention of stroke in resource-constrained settings and the first to incorporate mobile technologies for both healthcare providers and patients in China. The SINEMA model is innovative as it builds the capacity of primary healthcare workers in the rural area, uses mobile health technologies at the point of care, and addresses critical health needs for a vulnerable community-dwelling patient group. The findings of the study will provide translational evidence for other resource-constrained settings in developing strategies for the secondary prevention of stroke.

Trial registration: ClinicalTrials.gov NCT03185858.