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

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Abstract
Background and Aims: Non-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. Objective: The 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. Methods: This 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. Results: Currently, participant inclusion has been nearly completed. We are undergoing data clearing and are planning data analysis. These steps are planned for autumn 2025. Conclusion: This 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 Registration: SNCTP000004345; ClinicalTrials.gov Identifier: NCT04708756

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