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

NCT04458766 | Completed

• 1 other identifier: 1K23HL145109-01A1
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Familial Hypercholesterolemia; Adherence, Medication

Keywords

Adolescents; Medication adherence; Familial hypercholesterolemia; Behavioral economics; Mobile health technology

Outcome Measures

Primary Outcomes (3)

• 1.1: Baseline adherence level

  Baseline adherence level to determine eligibility of subjects

  Day 0

• 1.2: Change in adherence with monetary incentives

  Change in statin adherence in enrolled subjects following an intervention that includes access to the Wellth mobile phone application with reminders to take their medication, and will receive monetary incentives for taking medication as prescribed.

  Days 14-74

• 1.3: Change in adherence withOUT monetary incentives

  Change in statin adherence in enrolled subjects following an intervention that includes access to the Wellth application with reminders to take their medication, but with no monetary incentives.

  Days 75-134

Study Arms (1)

Interventions

EXPERIMENTAL

All subjects in this trial will receive the following interventions: 1. Pre-Intervention (Days 0-14): Subjects given access to Wellth application reminders, no incentives provided. A virtual "check in" with the study team will occur at the end of the pre-intervention period (14 days). 2. Intervention (Days 15-74): Subjects will use Wellth app for 60 days, with incentives provided at the 30- and 60-day mark. At the end of the intervention period (Day 60), the subject will attend a clinic visit with the medical provider and a fasting lipid panel and MMAS will also be collected at this time. 3. Post-intervention (Days 74-134): Subjects will continue to use the Wellth app and receive reminders, but with no incentives provided, for 60 days. A clinic visit, fasting lipid profile, and MMAS will also be collected following the post-intervention period.

Behavioral: Monetary incentives

Interventions

Monetary incentives BEHAVIORAL

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.

Interventions

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of Homozygous FH
• Residence in a long-term care facility where medications are administered
• May become pregnant
• History of adverse effect or allergy to a statin, or any ingredient in a statin

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Wellth Inc.: collaborator
• MMAS-8 with permission from Dr Donald Morisky. as written below: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (48)

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Related Links

• Ref 1: Statins for the prevention of cardiovascular events
• Ref 30: Doing it now or later.
• Ref 31: Are experimental economists prone to framing effects? A natural field experiment.
• Ref 34: Intrinsic and extrinsic motivation.
• Red 47: Promoting adherence and increasing life span

MeSH Terms

Conditions

Hyperlipoproteinemia Type II; Medication Adherence

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiologist and Instructor of Pediatrics

Model Details: This is a pre-post study design. The intervention group will have medication adherence measured prior to receiving incentives, medication adherence while receiving incentives, and medication adherence after discontinuation of the incentives.

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: January 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)