Elsevier

American Heart Journal

Volume 207, January 2019, Pages 27-39
American Heart Journal

Clinical Investigation
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

https://doi.org/10.1016/j.ahj.2018.08.015Get rights and content

Background

Despite the significant burden of stroke in rural China, secondary prevention of stroke is suboptimal. This study aims to develop a SINEMA for the secondary prevention of stroke in rural China and to evaluate the effectiveness of the model compared with usual care.

Methods

The SINEMA model is being implemented and evaluated through a 1-year cluster-randomized controlled trial in Nanhe County, Hebei Province in China. Fifty villages from 5 townships are randomized in a 1:1 ratio to either the intervention or the control arm (usual care) with a target to enroll 25 stroke survivors per village. Village doctors in the intervention arm (1) receive systematic cascade training by stroke specialists on clinical guidelines, essential medicines and behavior change; (2) conduct monthly follow-up visits with the support of a mobile phone application designed for this study; (3) participate in virtual group activities with other village doctors; 4) receive performance feedback and payment. Stroke survivors participate in a health education and project briefing session, receive monthly follow-up visits by village doctors and receive a voice message call daily as reminders for medication use and physical activities. Baseline and 1-year follow-up survey will be conducted in all villages by trained staff who are blinded of the randomized allocation of villages. The primary outcome will be systolic blood pressure and the secondary outcomes will include diastolic blood pressure, medication adherence, mobility, physical activity level and quality of life. Process and economic evaluation will also be conducted.

Discussion

This study is one of very few that aim to promote secondary prevention of stroke in resource-constrained settings and the first to incorporate mobile technologies for both healthcare providers and patients in China. The SINEMA model is innovative as it builds the capacity of primary healthcare workers in the rural area, uses mobile health technologies at the point of care, and addresses critical health needs for a vulnerable community-dwelling patient group. The findings of the study will provide translational evidence for other resource-constrained settings in developing strategies for the secondary prevention of stroke.

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.

. PIRIT Checklist.

. SINEMA Application and voice-message platform.

. Timeline cluster diagram for the SINEMA cluster trial.

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

References (69)

  • X. Li et al.

    The primary health-care system in China

    Lancet

    (2017)
  • D.J. Macfarlane et al.

    Reliability and validity of the Chinese version of IPAQ (short, last 7 days)

    J Sci Med Sport

    (2007)
  • C.A. Feldstein

    Lowering blood pressure to prevent stroke recurrence: a systematic review of long-term randomized trials

    J Am Soc Hypertens

    (2014)
  • V.L. Feigin

    Stroke in developing countries: can the epidemic be stopped and outcomes improved?

    Lancet Neurol

    (2007)
  • K. Strong et al.

    Preventing stroke: saving lives around the world

    Lancet Neurol

    (2007)
  • Global Burden of Disease Study 2016 (GBD 2016) Cause-Specific Mortality 1980-2016

    (2017)
  • W. Wang et al.

    Prevalence, incidence, and mortality of stroke in China: results from a nationwide population-based survey of 480 687 Adults

    Circulation

    (2017)
  • G. Xu et al.

    Recurrence after ischemic stroke in Chinese patients: impact of uncontrolled modifiable risk factors

    Cerebrovasc Dis

    (2007)
  • P. Rashid et al.

    Blood pressure reduction and secondary prevention of stroke and other vascular events. a systematic review

    (2003)
  • Yongjun Wang

    Chinese guideline for cerebrovascular disease tretment in primary healthcare settings

    (2016)
  • W.J. Powers et al.

    2018 guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association

    Stroke

    (2018)
  • World Health Organization

    Prevention of recurrent heart attacks and strokes in low and middle income populations: evidence-based recommendations for policy-makers and health professionals

    (2003)
  • J.W. Wei et al.

    Secondary prevention of ischemic stroke in Urban China

    Stroke

    (2010)
  • M.E. Kruk et al.

    Redesigning primary care to tackle the global epidemic of noncommunicable disease

    Am J Public Health

    (2015)
  • X. Liu et al.

    Financial protection of rural health insurance for patients with hypertension and diabetes: repeated cross-sectional surveys in rural China

    BMC Health Serv Res

    (2016)
  • R. Yan et al.

    Cardiovascular diseases and risk-factor burden in urban and rural communities in high-, middle-, and low-income regions of China: a large community-based epidemiological study

    J Am Heart Assoc

    (2017)
  • Y. Jiang et al.

    Persistence of secondary prevention medication and related factors for acute ischemic stroke and transient ischemic attack in China

    Neurol Res

    (2017)
  • A.B. Labrique et al.

    mHealth innovations as health system strengthening tools: 12 common applications and a visual framework

    Glob Health Sci Pract

    (2013)
  • S. Hamine et al.

    Impact of mHealth chronic disease management on treatment adherence and patient outcomes: a systematic review

    J Med Internet Res

    (2015)
  • A. Beratarrechea et al.

    The impact of mobile health interventions on chronic disease outcomes in developing countries: a systematic review

    Telemed E-Health

    (2014)
  • D. Peiris et al.

    Use of mHealth systems and tools for non-communicable diseases in low-and middle-income countries: a systematic review

    J Cardiovasc Transl Res

    (2014)
  • M. Tian et al.

    mHealth interventions for health system strengthening in China: a systematic review

    JMIR mHealth uHealth

    (2017)
  • M. Tian et al.

    A cluster-randomized controlled trial of a simplified multifaceted management program for individuals at high cardiovascular risk (SimCard Trial) in Rural Tibet, China, and Haryana, India

    Circulation

    (2015)
  • N. Li et al.

    The effects of a community-based sodium reduction program in rural China—a cluster-randomized trial

    PLoS One

    (2016)
  • Cited by (10)

    View all citing articles on Scopus

    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

    View full text