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NCT04458766Completed

The Use of Mobile Health Technology and Behavioral Economics to Encourage Adherence in Adolescents

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

Source: ClinicalTrials.gov · Last updated 21 Aug 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
11 (actual)
First submitted
1 Jul 2020
Start date
1 Jan 2021
Primary completion date
30 Jun 2024
Lead sponsor
Boston Children's Hospital
NCT number
NCT04458766

What you commit to

  • Study type: Interventional
  • Participants enrolled: 11
  • From 1 Jan 2021 to the primary completion date, 30 Jun 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Residence in a long-term care facility where medications are administered

Other illness

  • History of adverse effect or allergy to a statin, or any ingredient in a statin

Other

  • Diagnosis of Homozygous FH
  • May become pregnant

Who the study is looking for

  • Diagnosis of FH based on National Lipid Association (NLA) criteria and/or genetic testing
  • Prescribed a statin
  • Be able to provide written, informed consent or have a parent/guardian provide written, informed consent
  • Be able to use a mobile phone and application
  • Morisky Medication Adherence Scale score of ≤ 6

Age in the registry: 12 years to 21 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Boston Children's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.