NCT03185858

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,299

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

June 23, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 17, 2020

Status Verified

September 1, 2020

Enrollment Period

1.1 years

First QC Date

June 12, 2017

Last Update Submit

September 15, 2020

Conditions

Stroke

Keywords

secondary preventionprimary healthcarevillage doctorsrural Chinamedication adherencephysical activity

Outcome Measures

Primary Outcomes (1)

  • systolic blood pressure

    change in systolic blood pressure

    change from baseline to 12-month of follow-up

Secondary Outcomes (5)

  • mobility

    change from baseline to 12-month of follow-up

  • medication adherence

    change from baseline to 12-month of follow-up

  • physical activity level

    change from baseline to 12-month of follow-up

  • health related quality of life

    change from baseline to 12-month of follow-up

  • diastolic blood pressure

    change from baseline to 12-month of follow-up

Other Outcomes (3)

  • stroke recurrence and hospitalization

    at the end of the intervention (12-month)

  • disability

    at the end of the intervention (12-month)

  • Stroke related mortality

    at the end of the intervention (12-month)

Study Arms (2)

SINEMA intervention group

EXPERIMENTAL

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.

Behavioral: SINEMA intervention

Control group

NO INTERVENTION

Villages in the control arm continue their usual practice without the introduction of any of the SINEMA activities described above. People who have hypertension or who are at high-risk of hypertension may receive follow-up visits four times per year as part of the basic public health services required by the government.

Interventions

SINEMA interventionBEHAVIORAL

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.

SINEMA intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanhe County

Xingtai, Hebei, 054400, China

Location

Related Publications (6)

  • Yang B, Gong E, Chen X, Tan J, Peoples N, Li Y, Cai J, Li Y, Oldenburg B, Chen C, Dong D, Zhang X, Finkelstein E, Si L, Yan LL. Economic Evaluation of a Multicomponent mHealth Intervention for Stroke Management in Rural China: Cluster-Randomized Trial With 6-Year Follow-Up. JMIR Mhealth Uhealth. 2025 Sep 11;13:e75326. doi: 10.2196/75326.

    PMID: 40934495DERIVED

  • 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.

    PMID: 34869187DERIVED

  • 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.

    PMID: 33909607DERIVED

  • 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.

    PMID: 31462178DERIVED

  • 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.

    PMID: 31325288DERIVED

  • 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.

    PMID: 30408621DERIVED

MeSH Terms

Conditions

StrokeMedication AdherenceMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Lijing L. Yan, PhD

    Duke Kunshan Unviersity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessors (staffs from a nearby county) are masked with no information on which villages will be assigned to intervention group or control group.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2017

First Posted

June 14, 2017

Study Start

June 23, 2017

Primary Completion

July 31, 2018

Study Completion

December 31, 2019

Last Updated

September 17, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

The investigators will not share the individual participant data. But other researchers could contact PI if there is special inquiry.

Locations

CN(1)