Nanhe County
Xingtai, Hebei, 054400, China
NCT Number: NCT03185858
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Xingtai, Hebei, 054400, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
those who
Exclusion criteria
those who
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.
Time frame: change from baseline to 12-month of follow-up
change in systolic blood pressure
Time frame: 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
Time frame: 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
Time frame: change from baseline to 12-month of follow-up
measured using the short version of the International Physical Activity Questionnaire(IPAQ)
Time frame: change from baseline to 12-month of follow-up
measured using EuroQol-5 Dimensions-5L (EQ5D)
Time frame: change from baseline to 12-month of follow-up
participants' diastolic blood pressure
Time frame: at the end of the intervention (12-month)
will be collected through questionnaire and medical insurance records
Time frame: at the end of the intervention (12-month)
measured using modified Rankin Scale (ranged 0 (no symptom) to 5 severe disability)
Time frame: at the end of the intervention (12-month)
will be collected through questionnaire, medical insurance records and verbal autopsy
Duke Kunshan University
Other
System-integrated Technology-enabled Model of Care to Improve the Health of Stroke Patients in Rural China
Acronym: SINEMA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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