CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
Monetary incentivesbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04458766
NCT04458766N/ACompleted

The Use of Mobile Health Technology and Behavioral Economics to Encourage Adherence to Statins in Adolescents With Familial Hypercholesterolemia

Boston Children's Hospital·interventional·Posted Jul 7, 2020·Updated Aug 21, 2024

In Brief

A clinical study evaluating Monetary incentives for Familial Hypercholesterolemia and Adherence, Medication. Completed, enrolled 11 participants across 1 site.

Detailed Summary

Familial hypercholesterolemia (FH) affects over one million Americans and increases the risk of cardiovascular disease (CVD) by as much as 20-fold. Although the use of statins can substantially reduce this risk, adherence to statins in adults and adolescence is poor. In adults, lower rates of adherence are associated with an increased rate of CVD events and all-cause mortality, as well as an additional $44 billion annually in health care costs. Novel interventions are needed to improve medication adherence in patients with FH, starting in adolescents. An underused strategy to improve medication adherence incorporates the principles of behavioral economics. Traditional economic theory suggests that providing an incentive to perform a behavior will increase the frequency of that behavior. However, two prominent theories in behavioral economics, Present Bias and Loss Aversion, suggest that not all types of incentives are effective and that poorly structured incentives can actually be negative enforcers. With novel mobile health technologies (mHealth), interventions based on behavioral economics can now be studied on a larger scale. In this proposal, the investigators will test the use of monetary incentives ($30 per 30 days) to improve medication adherence in eligible subjects. The investigators will test the subject's adherence prior to the use of incentives (using the Morisky Medication Adherence Scale and the Wellth Mobile Application) and during the period of time the incentives are provided. Lastly, the investigators will test the subject's adherence (using the Morisky Medication Adherence Scale and Wellth App) during the 60 days following discontinuation of the incentives to determine if any effect of the incentive persists after the incentive is discontinued.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 7, 2020
Enrollment StartJan 1, 2021
Primary CompletionJun 30, 2024
Study CompletionJul 31, 2024
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 6.0 years ago

Interventions

Monetary incentivesbehavioral

This intervention will assess the efficacy of subjects using the Wellth mobile phone application to provide reminders to take their statin medication, and receiving monetary incentives for taking their medication as prescribed.