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 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. Author summary Why was this study done? In low- and middle-income countries, there is an urgent need to develop effective and cost-effective approaches to strengthen primary healthcare system in noncommunicable disease management. Rural China suffers from an increasing burden due to stroke, with no existing effective strategy to manage community-dwelling stroke patients. Results from mobile health studies, usually not integrating health solutions for both primary healthcare providers and patients, were mixed with some demonstrating effectiveness while others had neutral findings. What did the researchers do and find? We conducted a cluster-randomized controlled trial in rural China to investigate whether a primary care-based integrated mobile health intervention could improve blood pressure (BP) control and secondary prevention of stroke. We identified individuals with stroke from 50 villages. Villages allocated in the intervention arm received both provider and patient-facing interventions over 12 months. There was a significant net reduction in systolic BP between the intervention and control groups, and the intervention also led to significant improvement in other health outcomes and reduction in hospitalization and mortality among stroke patients in rural China. The program was well implemented with relatively high fidelity and low cost (US$24.3 per participant per year). What do these findings mean? A primary care-based integrated mobile health intervention that aims to overcome both health system and individual barriers could lead to an improvement in BP control and secondary prevention of stroke in rural China. This model, with low program delivery cost, has the potential, when adapted to local contexts appropriately, to be relevant to other chronic conditions and in other resource-limited settings.

Automated summary

This study showed that a primary care-based integrated mobile health intervention effectively improved blood pressure control and stroke secondary prevention in rural China, with significant reductions in systolic blood pressure and improvements in various health outcomes. The intervention had a high fidelity and low program delivery cost, suggesting its potential applicability in other chronic conditions and resource-limited settings when adapted appropriately.