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Monetary Incentives for High Cholesterol Adherence

N/A

Recruiting

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of FH based on National Lipid Association (NLA) criteria and/or genetic testing

Prescribed a statin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 75-134

Awards & highlights

Study Summary

This trial is testing whether monetary incentives can improve medication adherence in patients with familial hypercholesterolemia, a genetic disorder that greatly increases the risk of heart disease.

Who is the study for?

This trial is for adolescents with high cholesterol due to familial hypercholesterolemia (FH) who are prescribed statins and have a history of poor medication adherence. Participants must be able to use a mobile phone app, not live in long-term care, and not be at risk of pregnancy or allergic to statins.Check my eligibility

What is being tested?

The study tests if giving teens money ($30 every 30 days) helps them take their cholesterol medicine regularly. It uses an app and the Morisky Medication Adherence Scale before, during, and after getting incentives to see if the effect lasts without ongoing rewards.See study design

What are the potential side effects?

Since this trial involves monetary incentives rather than medical treatments, there aren't direct side effects like you'd expect from drugs. However, participants might experience disappointment or changes in motivation when incentives end.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Familial Hypercholesterolemia.

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I am currently taking a statin medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 75-134

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 75-134

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 75-134 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

1.1: Baseline adherence level

1.2: Change in adherence with monetary incentives

1.3: Change in adherence withOUT monetary incentives

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionsExperimental Treatment1 Intervention

All subjects in this trial will receive the following interventions: 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). 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. 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Monetary incentives

2015

N/A

~70

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

MMAS Research LLCUNKNOWN

Boston Children's HospitalLead Sponsor

761 Previous Clinical Trials

5,579,700 Total Patients Enrolled

Wellth Inc.Industry Sponsor

5 Previous Clinical Trials

618 Total Patients Enrolled

Media Library

Monetary incentives Clinical Trial Eligibility Overview. Trial Name: NCT04458766 — N/A

Medication Adherence Research Study Groups: Interventions

Medication Adherence Clinical Trial 2023: Monetary incentives Highlights & Side Effects. Trial Name: NCT04458766 — N/A

Monetary incentives 2023 Treatment Timeline for Medical Study. Trial Name: NCT04458766 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being accepted for this clinical trial?

"Affirmative, the information found on clinicaltrials.gov verifies that recruitment for this medical experiment is ongoing. This research was initially posted on January 1st 2021 and has been updated as recently as July 7th 2022. The study requires 30 test subjects from a single clinic to participate in it."

Answered by AI

Is this experiment actively seeking participants?

"Clinicaltrials.gov confirms that this clinical trial is actively searching for participants, with the initial posting on January 1st 2021 and a recent edit made on July 7th 2022."

Answered by AI

Does the age qualification for this experiment extend to those under 45 years of age?

"As stipulated by the study's selection criteria, participants should fall within a range of 12 and 21 years old."

Answered by AI

To what extent is participation in this research project open?

"This clinical trial, which is recruiting 30 participants, requires that all applicants have primary hypercholesterolemia and be between the ages of 12 to 21."

Answered by AI

Recent research and studies

Population Health ManagementJournal

The Association Between Achieving Low-density Lipoprotein Cholesterol (LDL-C) Goal and Statin Treatment in an Employee Population

Burton, Wayne N., Chin-Yu Chen, Alyssa B. Schultz, and Dee W. Edington. 2010. “The Association Between Achieving Low-density Lipoprotein Cholesterol (LDL-C) Goal and Statin Treatment in an Employee Population”. Population Health Management. Mary Ann Liebert Inc. doi:10.1089/pop.2009.0020.

The American Journal of CardiologyJournal

Adherence to Statins, Subsequent Healthcare Costs, and Cardiovascular Hospitalizations

Pittman, Donald G., William Chen, Steven J. Bowlin, and JoAnne M. Foody. 2011. “Adherence to Statins, Subsequent Healthcare Costs, and Cardiovascular Hospitalizations”. The American Journal of Cardiology. Elsevier BV. doi:10.1016/j.amjcard.2011.01.052.

Pediatric DrugsJournal

Long-term Statin Treatment in Children with Familial Hypercholesterolemia: More Insight into Tolerability and Adherence

Braamskamp, Marjet J. A. M., D. Meeike Kusters, Hans J. Avis, Ellen M. A. Smets, Frits A. Wijburg, John J. P. Kastelein, Albert Wiegman, and Barbara A. Hutten. 2015. “Long-term Statin Treatment in Children with Familial Hypercholesterolemia: More Insight into Tolerability and Adherence”. Pediatric Drugs. Springer Science and Business Media LLC. doi:10.1007/s40272-014-0116-y.

CirculationJournal