Clinical InvestigationSystem-integrated technology-enabled model of care to improve the health of stroke patients in rural China: protocol for SINEMA—a cluster-randomized controlled trial
Section snippets
Background
Stroke is the leading cause of deaths and disabilities in China with about 1.5-2 million new stroke cases each year and a total of about 7.5 million stroke survivors.1, 2 The most recent estimation showed that stroke led to about 18.5% of deaths in China and was the largest contributor to the loss of disability-adjusted life years in 2016.3 The incidence, prevalence, and mortality of stroke in rural China have all surpassed those in urban areas in recent years.4 In addition, recurrent stroke
Study site
This study is being conducted in Nanhe County, a county in Hebei Province, China, with an intention to generate solutions that can be adapted in other resource-limited settings. Nanhe County is located on the stroke belt of China, an area marked with a comparatively high prevalence of stroke.31 It is a “provincial poverty county” with an annual disposable income per capita as 11,030 RMB (less than half of the average national annual disposable income per capita).32 In Nanhe County, there are 2
Discussion
Combating the increasing burden of stroke and implementing effective secondary prevention strategies in resource-constrained settings is a global health priority.55, 56 The SINEMA study aims to implement the system-integrated technology-enabled model of care, using a behavior change theory, for the secondary prevention of stroke in rural China and to evaluate the effectiveness of the model through a cluster-randomized control trial. To the best of our knowledge, this trial is one of very few
List of abbreviations
- SINEMA
system-integrated technology-enabled intervention
- mHealth
Mobile Health
- APP
Application
- IPAQ
International Physical Activity Questionnaire
- EQ5D
EuroQol-5 Dimensions-5L
- CDC
Center of Disease Control and Prevention
The following are the supplementary data related to this article.
Ethics approval and consent to participate
The trial was registered at the clinicaltrials.gov (NCT03185858). The trial protocol received ethics approval from the institutional review boards at Duke University, USA and Beijing Tiantan Hospital, China. The pilot study received ethical approval from the institutional review board at Duke Kunshan University, China. All participants provided written informed consent when they were recruited to participate in the study.
Authors’ contributions
EG, WG, CS, and LLY drafted the manuscript. EG, WG, CS, JB, ET, YW, LX,
Acknowledgements
We would like to thank the independent International Steering Committee members (Yangfeng Wu, Eric Peterson, Craig Anderson, Shenglan Tang) and Advisory group members (Allan Burns, Ninghua Wang, Xie Bin, Jesse Hao, Jixiang Ma, Jixin Sun, Jianxin Zhang, Jinmei Liu) who have provided great advice in designing and implementing the study. The study is jointly funded through the Joint Health System Research Scheme by United Kingdom Medical Research Council, Wellcome Trust, Economic and Social
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Competing interests: The authors declare that they have no competing interests.
Trial registration: The trial was registered with clinicaltrials.gov (NCT03185858).
Deepak L. Bhatt, MD, MPH, served as guest editor for this article.
RCT# NCT03185858