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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SINEMA intervention
Sponsored by
Duke Kunshan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring secondary prevention, primary healthcare, village doctors, rural China, medication adherence, physical activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanhe County

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SINEMA intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

systolic blood pressure
change in systolic blood pressure

Secondary Outcome Measures

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
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
physical activity level
measured using the short version of the International Physical Activity Questionnaire(IPAQ)
health related quality of life
measured using EuroQol-5 Dimensions-5L (EQ5D)
diastolic blood pressure
participants' diastolic blood pressure

Full Information

First Posted
June 12, 2017
Last Updated
September 15, 2020
Sponsor
Duke Kunshan University
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT03185858
Brief Title
SINEMA Model of Care to Improve the Health of Stroke Patients in Rural China
Acronym
SINEMA
Official Title
System-integrated Technology-enabled Model of Care to Improve the Health of Stroke Patients in Rural China
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 23, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke Kunshan University
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
secondary prevention, primary healthcare, village doctors, rural China, medication adherence, physical activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
1299 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SINEMA intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SINEMA intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
systolic blood pressure
Description
change in systolic blood pressure
Time Frame
change from baseline to 12-month of follow-up
Secondary Outcome Measure Information:
Title
mobility
Description
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
Title
medication adherence
Description
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
Title
physical activity level
Description
measured using the short version of the International Physical Activity Questionnaire(IPAQ)
Time Frame
change from baseline to 12-month of follow-up
Title
health related quality of life
Description
measured using EuroQol-5 Dimensions-5L (EQ5D)
Time Frame
change from baseline to 12-month of follow-up
Title
diastolic blood pressure
Description
participants' diastolic blood pressure
Time Frame
change from baseline to 12-month of follow-up
Other Pre-specified Outcome Measures:
Title
stroke recurrence and hospitalization
Description
will be collected through questionnaire and medical insurance records
Time Frame
at the end of the intervention (12-month)
Title
disability
Description
measured using modified Rankin Scale (ranged 0 (no symptom) to 5 severe disability)
Time Frame
at the end of the intervention (12-month)
Title
Stroke related mortality
Description
will be collected through questionnaire, medical insurance records and verbal autopsy
Time Frame
at the end of the intervention (12-month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lijing L. Yan, PhD
Organizational Affiliation
Duke Kunshan Unviersity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanhe County
City
Xingtai
State/Province
Hebei
ZIP/Postal Code
054400
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators will not share the individual participant data. But other researchers could contact PI if there is special inquiry.
Citations:
PubMed Identifier
34869187
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.
Results Reference
derived
PubMed Identifier
33909607
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.
Results Reference
derived
PubMed Identifier
31462178
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.
Results Reference
derived
PubMed Identifier
31325288
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.
Results Reference
derived
PubMed Identifier
30408621
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.
Results Reference
derived

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

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