A targeted behavioural economics-based intervention to improve medication adherence in patients with Hypertension: the BEHAVE-HTN study protocol

Background and AimsNon-adherence to antihypertensive therapy is a major contributor to poor blood pressure (BP) control, increased cardiovascular risk, and higher healthcare costs. Behavioral economics suggests that financial incentives and mobile-based interventions may support behavior change, yet evidence for such strategies in central Europe is limited. ObjectiveThe BEHAVE-HTN study evaluates whether a multi-faceted medication adherence mobile application (mApp) with behavioral economic principles--including reminders, gamification, and financial incentives--improves medication adherence in patients with hypertension compared to standard of care. MethodsThis multi-center, randomized, open-label trial will include 180 outpatients with hypertension taking four or more pills daily. Participants will be randomized into three groups (n = 60 per group): (A) mApp with contingent financial incentives, (B) mApp without incentives, and (C) standard of care. All participants will receive a Medication Event Monitoring System (MEMS) dispenser to objectively track adherence. The primary endpoint is the difference in mean MEMS adherence between group A and the control group at 90 days. A co-primary endpoint compares MEMS adherence in the final vs. initial month of the intervention. Secondary outcomes include changes in BP, app-reported adherence, and patient-reported feedback on the mApp. ResultsCurrently, participant inclusion has been nearly completed. We are undergoing data clearing and are planning data analysis. These steps are planned for autumn 2025. ConclusionThis study will provide evidence on whether a multi-faceted medication adherence mobile App -- with or without financial incentives--can improve medication adherence in hypertensive patients. The findings may support the implementation of mobile health strategies in routine hypertension care. Trial RegistrationSNCTP000004345; ClinicalTrials.gov Identifier: NCT04708756