Clinical trial NCT03185858: SINEMA Model of Care to Improve the Health of Stroke Patients in Rural China
Official title: System-integrated Technology-enabled Model of Care to Improve the Health of Stroke Patients in Rural China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: secondary prevention
primary healthcare
village doctors
rural China
medication adherence
physical activity
Lead sponsor: Duke Kunshan University
Sponsor class: OTHER
Collaborators: name: Medical Research Council
name: Wellcome Trust
name: Economic and Social Research Council, United Kingdom
name: Department for International Development, United Kingdom
name: Beijing Tiantan Hospital
name: China Mobile Research Institute
name: Xingtai Center for Disease Control and Prevention, China
name: Centers for Disease Control and Prevention, China
name: Duke University
First posted: 2017-06-14
Enrollment: 1299
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: systolic blood pressure
timeFrame: change from baseline to 12-month of follow-up
Secondary outcomes:
measure: mobility
timeFrame: change from baseline to 12-month of follow-up
measure: medication adherence
timeFrame: change from baseline to 12-month of follow-up
measure: physical activity level
timeFrame: change from baseline to 12-month of follow-up
measure: health related quality of life
timeFrame: change from baseline to 12-month of follow-up
measure: diastolic blood pressure
timeFrame: change from baseline to 12-month of follow-up
Other outcomes:
measure: stroke recurrence and hospitalization
timeFrame: at the end of the intervention (12-month)
measure: disability
timeFrame: at the end of the intervention (12-month)
measure: Stroke related mortality
timeFrame: at the end of the intervention (12-month)
Locations:
city: Xingtai
country: China
facility: Nanhe County
state: Hebei
Study officials:
affiliation: Duke Kunshan Unviersity
name: Lijing L. Yan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gong E, Sun L, Long Q, Xu H, Gu W, Bettger JP, Tan J, Ma J, Jafar TH, Oldenburg B, Yan LL. The Implementation of a Primary Care-Based Integrated Mobile Health Intervention for Stroke Management in Rural China: Mixed-Methods Process Evaluation. Front Public Health. 2021 Nov 17;9:774907. doi: 10.3389/fpubh.2021.774907. eCollection 2021.
citation: Yan LL, Gong E, Gu W, Turner EL, Gallis JA, Zhou Y, Li Z, McCormack KE, Xu LQ, Bettger JP, Tang S, Wang Y, Oldenburg B. Effectiveness of a primary care-based integrated mobile health intervention for stroke management in rural China (SINEMA): A cluster-randomized controlled trial. PLoS Med. 2021 Apr 28;18(4):e1003582. doi: 10.1371/journal.pmed.1003582. eCollection 2021 Apr.
citation: Gong E, Yan LL, McCormack K, Gallis JA, Bettger JP, Turner EL. System-integrated technology-enabled model of care (SINEMA) to improve the health of stroke patients in rural China: Statistical analysis plan for a cluster-randomized controlled trial. Int J Stroke. 2020 Feb;15(2):226-230. doi: 10.1177/1747493019869707. Epub 2019 Aug 28.
citation: Wu N, Gong E, Wang B, Gu W, Ding N, Zhang Z, Chen M, Yan LL, Oldenburg B, Xu LQ. A Smart and Multifaceted Mobile Health System for Delivering Evidence-Based Secondary Prevention of Stroke in Rural China: Design, Development, and Feasibility Study. JMIR Mhealth Uhealth. 2019 Jul 19;7(7):e13503. doi: 10.2196/13503.
citation: Gong E, Gu W, Sun C, Turner EL, Zhou Y, Li Z, Bettger JP, Oldenburg B, Amaya-Burns A, Wang Y, Xu LQ, Yao J, Dong D, Xu Z, Li C, Hou M, Yan LL. 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. Am Heart J. 2019 Jan;207:27-39. doi: 10.1016/j.ahj.2018.08.015. Epub 2018 Sep 5.