Comparison of Outreach Approaches to Increase Enrollment in a Healthy Cholesterol Study

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial of Outreach Approaches to Increase Enrollment in the Habit Formation for Adherence to Statin Use and LDL Reduction Study

Conditions
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Diabetes

Intervention / Treatment
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* Other: Large Envelope
* Other: Priority Mail
* Other: Amazon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Normal Letter<br>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. | |
| Experimental: Large Envelope<br>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. | Other: Large Envelope<br> <br> |
| Experimental: Priority Mail<br>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. | Other: Priority Mail<br> <br> |
| Experimental: Amazon<br>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. | Other: Amazon<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment into the Habit Formation study |  | 3 months |