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

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ClinicalTrials.gov Identifier: NCT03185858
Recruitment Status : Active, not recruiting
First Posted : June 14, 2017
Last Update Posted : August 16, 2018
Sponsor:
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
Information provided by (Responsible Party):
Duke Kunshan University

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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: SINEMA intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1299 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (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.
Primary Purpose: Prevention
Official Title: System-integrated Technology-enabled Model of Care to Improve the Health of Stroke Patients in Rural China
Actual Study Start Date : May 23, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: SINEMA intervention group
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

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.


No Intervention: Control group
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.



Primary Outcome Measures :
  1. systolic blood pressure [ Time Frame: change from baseline to 12-month of follow-up ]
    change in systolic blood pressure


Secondary Outcome Measures :
  1. mobility [ 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

  2. medication adherence [ 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

  3. physical activity level [ Time Frame: change from baseline to 12-month of follow-up ]
    measured using the short version of the International Physical Activity Questionnaire(IPAQ)

  4. health related quality of life [ Time Frame: change from baseline to 12-month of follow-up ]
    measured using EuroQol-5 Dimensions-5L (EQ5D)

  5. diastolic blood pressure [ Time Frame: change from baseline to 12-month of follow-up ]
    participants' diastolic blood pressure


Other Outcome Measures:
  1. stroke recurrence [ Time Frame: at the end of the intervention (12-month) ]
    will be collected through questionnaire and medical insurance records

  2. Stroke related morbidity [ Time Frame: at the end of the intervention (12-month) ]
    will be collected through questionnaire and medical insurance records

  3. Stroke related mortality [ Time Frame: at the end of the intervention (12-month) ]
    will be collected through questionnaire and medical insurance records



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185858


Locations
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China, Hebei
Nanhe County
Xingtai, Hebei, China, 054400
Sponsors and Collaborators
Duke Kunshan University
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
Investigators
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Principal Investigator: Lijing L. Yan, PhD Duke Kunshan Unviersity

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke Kunshan University
ClinicalTrials.gov Identifier: NCT03185858     History of Changes
Other Study ID Numbers: 2015MRC0012
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators will not share the individual participant data. But other researchers could contact PI if there is special inquiry.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke Kunshan University:
secondary prevention
primary healthcare
village doctors
rural China
medication adherence
physical activity
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases