The Use of Mobile Health Technology and Behavioral Economics to Encourage Adherence to Statins and Blood Pressure Lowering Medication in Adolescents with Familial Hypercholesterolemia or Hypertension: Protocol for Pre-Post Comparison Study (Preprint)

BACKGROUND Cardiovascular disease (CVD) is a leading cause of mortality and morbidity in the United States, with risk factors such as hypertension and elevated 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 applications, may enhance adherence, but evidence in youth is lacking. OBJECTIVE This study aims to evaluate the efficacy of a smartphone application (Wellth®) offering financial incentives to improve adherence to statins and blood pressure-lowering medications among youth aged 12-19 at risk for cardiovascular disease. METHODS We initially designed a randomized controlled trial to compare the efficacy of two 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 application 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.