Stroke
Conditions
Keywords
secondary prevention, primary healthcare, village doctors, rural China, medication adherence, physical activity
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.
Interventions
BEHAVIORALSINEMA intervention
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.
Sponsors
Medical Research Council
Wellcome Trust
Economic and Social Research Council, United Kingdom
Department for International Development, United Kingdom
Beijing Tiantan Hospital
China Mobile Research Institute
Xingtai Center for Disease Control and Prevention, China
Centers for Disease Control and Prevention, China
Duke University
Duke Kunshan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessors (staffs from a nearby county) are masked with no information on which villages will be assigned to intervention group or control group.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| systolic blood pressure | change from baseline to 12-month of follow-up | change in systolic blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Stroke related mortality | at the end of the intervention (12-month) | will be collected through questionnaire, medical insurance records and verbal autopsy |
| disability | at the end of the intervention (12-month) | measured using modified Rankin Scale (ranged 0 (no symptom) to 5 severe disability) |
| stroke recurrence and hospitalization | at the end of the intervention (12-month) | will be collected through questionnaire and medical insurance records |
Countries
China
Outcome results
None listed