SINEMA Model of Care to Improve the Health of Stroke Patients in Rural China
- Conditions
- Stroke
- Interventions
- Behavioral: SINEMA intervention
- Registration Number
- NCT03185858
- Lead Sponsor
- Duke Kunshan University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1299
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SINEMA intervention group SINEMA intervention 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.
- Primary Outcome Measures
Name Time Method systolic blood pressure change from baseline to 12-month of follow-up change in systolic blood pressure
- Secondary Outcome Measures
Name Time Method mobility change from baseline to 12-month of follow-up 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
medication adherence change from baseline to 12-month of follow-up 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
physical activity level change from baseline to 12-month of follow-up measured using the short version of the International Physical Activity Questionnaire(IPAQ)
health related quality of life change from baseline to 12-month of follow-up measured using EuroQol-5 Dimensions-5L (EQ5D)
diastolic blood pressure change from baseline to 12-month of follow-up participants' diastolic blood pressure
Trial Locations
- Locations (1)
Nanhe County
🇨🇳Xingtai, Hebei, China