SINEMA Model of Care to Improve the Health of Stroke Patients in Rural China (SINEMA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03185858|
Recruitment Status : Active, not recruiting
First Posted : June 14, 2017
Last Update Posted : August 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Behavioral: SINEMA intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1299 participants|
|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.|
|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|
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.
- systolic blood pressure [ Time Frame: change from baseline to 12-month of follow-up ]change in systolic blood pressure
- 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
- 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
- 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)
- health related quality of life [ Time Frame: change from baseline to 12-month of follow-up ]measured using EuroQol-5 Dimensions-5L (EQ5D)
- diastolic blood pressure [ Time Frame: change from baseline to 12-month of follow-up ]participants' diastolic blood pressure
- stroke recurrence [ Time Frame: at the end of the intervention (12-month) ]will be collected through questionnaire and medical insurance records
- Stroke related morbidity [ Time Frame: at the end of the intervention (12-month) ]will be collected through questionnaire and medical insurance records
- Stroke related mortality [ Time Frame: at the end of the intervention (12-month) ]will be collected through questionnaire and medical insurance records
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
|Xingtai, Hebei, China, 054400|
|Principal Investigator:||Lijing L. Yan, PhD||Duke Kunshan Unviersity|