Overview

This trial is active, not recruiting.

Condition medication adherence
Treatments sweepstake incentive 1, sweepstake incentive 2, sweepstake incentive 3
Phase phase 3
Sponsor University of Pennsylvania
Collaborator Carnegie Mellon University
Start date July 2013
End date May 2017
Trial size 800 participants
Trial identifier NCT01798784, 1R01AG043844-01, 5R01AG043844

Summary

In a 4-arm, Randomized Control Trial among members of CVS Caremark or Penn Medicine Patients with suboptimal cholesterol control who are at high risk for CVD, the study investigators propose to test the effectiveness of different behavioral economic techniques in inducing habit formation for adherence to statin use and sustained reductions in LDL cholesterol after financial incentives are discontinued. Primary outcome is changes in LDL from enrollment to 12 months (6 months after cessation of financial incentives).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(No Intervention)
Arm 1 will be the Control arm, in which participants receive an electronic pill container and are provided with daily reminders to take their medication but are not enrolled in the sweepstakes.
(Experimental)
Arm 2 will be a sweepstakes incentive arm where participants receive an electronic pill container and daily reminders to take their medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication.
sweepstake incentive 1
Daily sweepstake conditional on daily medication adherence
(Experimental)
Arm 3 will be a sweepstake incentive arm where participants receive an electronic pill container and daily reminders to take their medication. In addition, this group is enrolled in a sweepstakes, in which monetary prizes may be awarded if participants take their medication prior to receiving a reminder.
sweepstake incentive 2
Daily sweepstake conditional on daily medication adherence
(Experimental)
Arm 4 will be a sweepstake incentive arm where participants receive an electronic pill container and daily reminders to take their medication. In addition, this group is enrolled in a sweepstakes, in which each participant maintains an account that will accumulate money based on their medication adherence throughout the study.
sweepstake incentive 3
Daily sweepstake conditional on daily medication adherence

Primary Outcomes

Measure
Change in LDL from baseline to 12 months
time frame: 12 months

Secondary Outcomes

Measure
Statin Adherence 6 months after active phase of intervention
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Individuals at high risk of a cardiac event, specifically one of the following: - Individuals with clinical CVD (defined as diagnosis with myocardial infarction, stroke, or peripheral vascular disease) with an LDL greater than or equal to 100 mg/dl ; - Individuals with Diabetes (between the ages of 40-75) with an LDL greater than or equal to 100 mg/dl; - Individuals without clinical CVD or diabetes with LDL greater than or equal to 100 mg/dl and estimated 10-year CVD risk 7.5%; - Individuals without clinical CVD or diabetes with LDL cholesterol greater than or equal to 190 mg/dl A prescription filled for a statin medication within the last 12 months (derived from pharmacy records); - Medication Possession Ratio (MPR) less than or equal to 80% - A score 0 on the 8-item Morisky Medication Adherence Questionnaire completed during enrollment Exclusion Criteria: - Less than 18 years old - Contraindication to further statin use or have suffered side effects from statins, such as myopathy - Will not or cannot give consent - History of active or progressive liver disease or abnormal liver function tests on baseline screening - Currently participating in another clinical trial with related aims - Co-morbidities likely to lead to death within a short-period

Additional Information

Official title Testing Behavioral Economic Interventions to Improve Statin Use and Reduce CVD Risk
Principal investigator Kevin Volpp, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Pennsylvania.