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

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Other: Amazon; Other: Large Envelope; Other: Priority Mail

• Registration Number: NCT02086539
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-11
• Study First Submitted QC: 2014-03-11
• Study First Posted: 2014-03-13
• Study Start: 2014-04
• Primary Completion: 2016-07-23
• Study Completion: 2016-07-23
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-26
• Last Update Posted: 2017-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amazon	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.
Large Envelope	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.
Priority Mail	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.

Primary Outcome Measures

Name	Time	Method
Enrollment into the Habit Formation study	3 months

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States