JMIR Mhealth Uhealth. 2025 Sep 11;13:e75326. doi: 10.2196/75326.
ABSTRACT
BACKGROUND: To bridge the gap between clinical guidelines and suboptimal stroke management in rural settings, we conducted an implementation trial using evidence-based, mobile health-enabled strategies to empower primary care providers in rural China. The system-integrated and digital technology-enabled model of care (SINEMA) model was shown to significantly reduce blood pressure and mortality among people with stroke in rural China.
OBJECTIVE: This study aimed to evaluate the cost-effectiveness of the SINEMA intervention within both the active trial and the post-trial observational periods and its budget impact for potential nationwide scalability.
METHODS: In the cluster-randomized implementation trial (the SINEMA trial), 50 villages were randomized to either a 1-year intervention (2017-2018) or usual care, with 1299 patients with stroke followed up until 2022-2023-6 years after the trial baseline. The incremental cost-effectiveness ratios (ICER) for systolic blood pressure reduction and quality-adjusted life year gains were estimated from a health sector perspective. Both probabilistic and deterministic sensitivity analyses were conducted to assess the robustness of the findings. Additionally, a budget impact analysis was performed from a public payer perspective to estimate the per-capita and total costs of national scale-up under 2 scenarios: a standalone intervention and integration into the existing basic public health service system.
RESULTS: The ICER per 1 mmHg systolic blood pressure reduction was $8.4 for the within-trial estimation. The ICER per quality-adjusted life year gained was $837.9 within-trial and $727.9 post-trial, both highly cost-effective relative to any commonly adopted thresholds and robust in sensitivity analyses. The first-year budget impact ranged from $115.6 million to $197.7 million in the 2 scenarios, reducing to $46.6 million to $78.7 million by year 5, with a per-capita cost of $0.03-$0.06.
CONCLUSIONS: Our findings demonstrate that the SINEMA intervention was cost-effective during the trial period and remained so throughout the 6-year sustainability observation period. These results highlight the potential of adopting similar health system-integrated, mobile health-enabled strategies to enhance the management of stroke and other chronic diseases in resource-limited settings.
TRIAL REGISTRATION: ClinicalTrials.gov NCT0318585, ClinicalTrials.gov NCT05792618; https://clinicaltrials.gov/study/NCT03185858 and https://clinicaltrials.gov/study/NCT05792618.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.3389/fneur.2023.1145562.
PMID:40934495 | DOI:10.2196/75326
