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

Stroke Clinical Trial

— SINEMA  

Official title:

System-integrated Technology-enabled Model of Care to Improve the Health of Stroke Patients in Rural China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03185858
• Other study ID #: 2015MRC0012
• Status: Completed
• Phase: N/A
• Start date: June 23, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2020
• Source: Duke Kunshan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1299
• Est. completion date: December 31, 2019
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• SINEMA 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.

Locations

Country	Name	City	State
China	Nanhe County	Xingtai	Hebei

Sponsors (10)

Lead Sponsor	Collaborator
Duke Kunshan University	Beijing Tiantan Hospital, Centers for Disease Control and Prevention, China, China Mobile Research Institute, Department for International Development, United Kingdom, Duke University, Economic and Social Research Council, United Kingdom, Medical Research Council, Wellcome Trust, Xingtai Center for Disease Control and Prevention, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	stroke recurrence and hospitalization	will be collected through questionnaire and medical insurance records	at the end of the intervention (12-month)
Other	disability	measured using modified Rankin Scale (ranged 0 (no symptom) to 5 severe disability)	at the end of the intervention (12-month)
Other	Stroke related mortality	will be collected through questionnaire, medical insurance records and verbal autopsy	at the end of the intervention (12-month)
Primary	systolic blood pressure	change in systolic blood pressure	change from baseline to 12-month of follow-up
Secondary	mobility	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	change from baseline to 12-month of follow-up
Secondary	medication adherence	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	change from baseline to 12-month of follow-up
Secondary	physical activity level	measured using the short version of the International Physical Activity Questionnaire(IPAQ)	change from baseline to 12-month of follow-up
Secondary	health related quality of life	measured using EuroQol-5 Dimensions-5L (EQ5D)	change from baseline to 12-month of follow-up
Secondary	diastolic blood pressure	participants' diastolic blood pressure	change from baseline to 12-month of follow-up