A targeted behavioural economics-based intervention to improve medication adherence in patients with Hypertension: the COLLABREE study protocol (Preprint)

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Abstract
BACKGROUND Non-adherence to antihypertensive therapy is a major contributor to poor blood pressure 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 COLLABREE study evaluates whether a multi-faceted mobile application 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) Collabree app with contingent financial incentives, (B) Collabree app without incentives, and (C) standard of care. All participants will receive a Medication Event Monitoring System (MEMS) to objectively track adherence. The primary endpoint is the difference in mean adherence between Group A and the control group at 90 days. A co-primary endpoint compares adherence in the final vs. initial month of the intervention. Secondary outcomes include changes in blood pressure, self-reported adherence, and patient-reported feedback on the app. 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. CONCLUSIONS This study will provide evidence on whether a multi-faceted digital intervention—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. CLINICALTRIAL SNCTP000004345; ClinicalTrials.gov Identifier: NCT04708756

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