Effectiveness of a primary care-based integrated mobile health intervention for stroke management in rural China (SINEMA): A cluster-randomized controlled trial
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Background: Managing noncommunicable diseases through primary healthcare has been identified as the key strategy to achieve universal health coverage but is challenging in most low- and middle-income countries. Stroke is the leading cause of death and disability in rural China. This study aims to determine whether a primary care-based integrated mobile health intervention (SINEMA intervention) could improve stroke management in rural China. Methods and findings: Based on extensive barrier analyses, contextual research, and feasibility studies, we conducted a community-based, two-arm cluster-randomized controlled trial with blinded outcome assessment in Hebei Province, rural Northern China including 1,299 stroke patients (mean age: 65.7 [SD:8.2], 42.6% females, 71.2% received education below primary school) recruited from 50 villages between June 23 and July 21, 2017. Villages were randomly assigned (1:1) to either the intervention or control arm (usual care). In the intervention arm, village doctors who were government-sponsored primary healthcare providers received training, conducted monthly follow-up visits supported by an Android-based mobile application, and received performance-based payments. Participants received monthly doctor visits and automatically dispatched daily voice messages. The primary outcome was the 12-month change in systolic blood pressure (BP). Secondary outcomes were predefined, including diastolic BP, health-related quality of life, physical activity level, self-reported medication adherence (antiplatelet, statin, and antihypertensive), and performance in “timed up and go” test. Analyses were conducted in the intention-to-treat framework at the individual level with clusters and stratified design accounted for by following the prepublished statistical analysis plan. All villages completed the 12-month follow-up, and 611 (intervention) and 615 (control) patients were successfully followed (3.4% lost to follow-up among survivors). The program was implemented with high fidelity, and the annual program delivery cost per capita was US$24.3. There was a significant reduction in systolic BP in the intervention as compared with the control group with an adjusted mean difference: −2.8 mm Hg (95% CI −4.8, −0.9;p= 0.005). The intervention was significantly associated with improvements in 6 out of 7 secondary outcomes in diastolic BP reduction (p< 0.001), health-related quality of life (p= 0.008), physical activity level (p< 0.001), adherence in statin (p= 0.003) and antihypertensive medicines (p= 0.039), and performance in “timed up and go” test (p= 0.022). We observed reductions in all exploratory outcomes, including stroke recurrence (4.4% versus 9.3%; risk ratio [RR] = 0.46, 95% CI 0.32, 0.66; risk difference [RD] = 4.9 percentage points [pp]), hospitalization (4.4% versus 9.3%; RR = 0.45, 95% CI 0.32, 0.62; RD = 4.9 pp), disability (20.9% versus 30.2%; RR = 0.65, 95% CI 0.53, 0.79; RD = 9.3 pp), and death (1.8% versus 3.1%; RR = 0.52, 95% CI 0.28, 0.96; RD = 1.3 pp). Limitations include the relatively short study duration of only 1 year and the generalizability of our findings beyond the study setting. Conclusions: In this study, a primary care-based mobile health intervention integrating provider-centered and patient-facing technology was effective in reducing BP and improving stroke secondary prevention in a resource-limited rural setting in China. Trial registration: ClinicalTrials.gov NCT03185858.
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Integration with existing health systems or local service delivery models is a facilitator to digital health uptake.
“Another highly considerable facilitator to digital health uptake is the integration with existing health systems or local service delivery models, as was mentioned in two of the included studies in China71,74, which was also recommended by a WHO policy brief90.”
From Digital health interventions for non-communicable disease management in primary health care in low-and middle-income countries (2023) · cites this paper as [74]
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Self-citation
- Authors
- Yan, L. L., Gong, E., Gu, W., Turner, E. L., Gallis, J. A., Zhou, Y., Li, Z., McCormack, K. E., Xu, L.-Q., Bettger, J. P., Tang, S., Wang, Y., & Oldenburg, B.
- Affiliations
- Duke University (US)
- The University of Melbourne (AU)
- Duke Kunshan University (CN)
- Capital Medical University (CN)
- China Mobile (China) (CN)
- Corresponding author
- Yan, Lijing L.
- ORCID
- Venue
- PLOS Medicine
- Publisher
- Public Library of Science (PLoS)
- Published
- 2021-04-28
- Volume
- 18
- Issue
- 4
- Pages
- e1003582
- ISSN
- 1549-1277 (ISSN-L)
- 1549-1676
- PMC
- PMC8115798
- OpenAlex
- W3159965987
- Cited by
- 98
- References
- 44
- Citations by year
- 2026: 15 · 2025: 25 · 2024: 26 · 2023: 18 · 2022: 13 · 2021: 1
- FWCI
- 16.29
- Type
- journal article
- Language
- en
- Update notices
- new_version (2021-05-12)
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Minerva Access (University of Melbourne) (submittedVersion, cc-by)
- RePEc: Research Papers in Economics (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Figshare (submittedVersion, cc-by)
- La Trobe University (cc-by)
- Funders
- Medical Research Council, Economic and Social Research Council, Department for International Development, Wellcome Trust (Grant No: MR/N015967/1)
- National Science Foundation (71774075)
- The University of Melbourne (Graduate Scholarship)
- National Health and Medical Research Council (1170937)
- Topics
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Physical Sciences › Computer Science › Information Systems › ICT in Developing Communities
- Keywords
- stroke management, mobile health, primary care, rural China, village doctors, blood pressure control, hypertension, medication adherence, health-related quality of life, physical activity, performance-based pay, voice mail, telemedicine, health professions education, universal health coverage, cost-effectiveness, Hebei Province, northern China, low- and middle-income countries
- MeSH terms
- Aged, Blood Pressure, China, Female, Humans, Male, Middle Aged, Primary Health Care, Quality of Life, Exercise, Telemedicine, Stroke, Medication Adherence, Secondary Prevention, Mobile Applications
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