Comprehensive Management of High-Risk Populations for Stroke Based on Social Networks in China: A Multicenter Randomized Clinical Trial (COMPLIANCE-MT)

BackgroundSuboptimal adherence to preventive medications and inadequate management of risk factors are major barriers to effective post-discharge care for individuals at high risk of stroke, particularly in resource-constrained settings. Digital health interventions delivered via widely accessible platforms offer a promising scalable approach. We conducted this trial to evaluate the efficacy of Social Network based patient care in improving medication adherence in high-risk populations for stroke. MethodCOMPLIANCE-MT is a multicenter, prospective, randomized, open-label, parallel-group trial with blinded outcome assessment (PROBE design) assessing the superiority of Social Network-based care versus conventional care in medication adherence for high-risk populations for stroke. A total of 720 participants will be recruited across 33 hospitals in China and randomized in a 1:1 ratio to either a 12-month Social Network (WeChat) based coordinated care program or routine follow-up. The primary outcome is the proportion of patients achieving more than 80% adherence to all indicated vascular prevention medications (antihypertensives, hypoglycemics, lipid-lowering agents, anticoagulants, and antiplatelets) at 12 months. Analysis will be performed on an intention-to-treat approach. DiscussionThe COMPLIANCE trial evaluates a social network-based intervention in improving adherence to five evidence-based vascular prevention medications in both primary prevention and secondary prevention. If proven effective, this model could inform national strategies for preventing strokes in resource-limited settings. Trial registration: ClinicalTrials.gov NCT05963828.