Abstract
BACKGROUND: Cardiovascular disease (CVD) is a leading cause of mortality and morbidity in the United States, with risk factors such as hypertension and elevated low-density lipoprotein (LDL) cholesterol originating in childhood. While statins and blood pressure-lowering medications can mitigate these risks, adherence is often poor, particularly among youth. Innovative solutions, such as monetary incentives via smartphone apps, may enhance adherence, but evidence in youth is lacking. OBJECTIVE: This study aims to evaluate the efficacy of a smartphone app (Wellth) offering financial incentives to improve adherence to statins and blood pressure-lowering medications among youth aged 12 to 19 years at risk for cardiovascular disease. METHODS: We initially designed a randomized controlled trial to compare the efficacy of 2 different incentive structures in youth treated with a statin for familial hypercholesterolemia with inadequate adherence. After facing recruitment challenges, the study protocol was changed to evaluating a single incentive in a pre-post design. The primary outcome was the change in adherence rate over the 60-day incentive period compared to the adherence rate during the 14-day run-in period. The secondary outcome was a change in LDL cholesterol level. Adjustments to the protocol were made in response to recruitment challenges during the COVID-19 pandemic, simplifying the incentive structure and expanding eligibility criteria. RESULTS: The study is currently undergoing recruitment and collection of data from the first participants. The study has faced recruitment challenges exacerbated by the COVID-19 pandemic, necessitating protocol modifications. Detailed analysis of adherence rates and LDL cholesterol changes is ongoing. CONCLUSIONS: This study explores the efficacy of monetary incentives delivered through a smartphone app to improve medication adherence in youth at risk for CVD. The findings will be used to build upon the existing literature in an effort to improve medication adherence throughout the life course and ultimately reduce CVD. TRIAL REGISTRATION: ClinicalTrials.gov NCT04458766; https://clinicaltrials.gov/study/NCT04458766. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/65105.