A Randomized Controlled Trial of Outreach Approaches to Increase Enrollment in the Habit Formation for Adherence to Statin Use and LDL Reduction Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Enrollment into the Habit Formation study
Study Overview
Brief Summary
This study aims to determine the effectiveness of 4 different recruitment techniques for enrollment into a cholesterol study. 2,000 people that meet initial eligibility criteria for the study will be randomized into one of 4 groups and will all receive the same recruitment letter inviting them to participate in the study by enrolling on an online platform. Group 1 will receive the recruitment letter in a normal sized envelope, Group 2 will receive the recruitment letter in an 8.5 x 11 inch envelope, Group 3 will receive a recruitment letter shipped via USPS priority mail and a Group 4 will receive a recruitment letter with the image of an Amazon gift card and told they will receive a $25 gift card if they enroll in the study. All other groups are told that they will receive a $25 check upon enrollment in the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diabetes and or history of CVD
- •LDL > or = 130 mg/dl - measured during screening
- •A prescription filled for statin medication within the last 12 months
- •Medication Possession Ratio (MPR) <80%
- •CVS Caremark Beneficiary
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
Arms & Interventions
Normal Letter
This arm will receive the recruitment letter in a business sized envelope. The letter states the participant will receive a $25 check upon enrollment into the study.
Large Envelope
This arm will receive the recruitment letter in an 8.5 x 11 inch envelope. The letter states the participant will receive a $25 check upon enrollment into the study.
Intervention: Large Envelope (Other)
Priority Mail
Group 3 will receive a recruitment letter shipped via USPS priority mail. The letter states the participant will receive a $25 check upon enrollment into the study.
Intervention: Priority Mail (Other)
Amazon
This arm will receive a recruitment letter with the image of an Amazon gift card and told they will receive the $25 gift card if they enroll in the study.
Intervention: Amazon (Other)
Outcomes
Primary Outcomes
Enrollment into the Habit Formation study
Time Frame: 3 months
Secondary Outcomes
No secondary outcomes reported