Effectiveness of a primary care-based integrated mobile health intervention for stroke management in rural China (SINEMA): A cluster-randomized controlled trial

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 US24. 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.