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

University of Pennsylvania

Status: Completed

Conditions: Diabetes

Treatments: Other: Priority Mail; Other: Large Envelope; Other: Amazon

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02086539

816003

5R01AG043844-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups

Normal Letter

No Intervention group

Description:

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

Experimental group

Description:

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.

Treatment:

Other: Large Envelope

Priority Mail

Experimental group

Description:

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.

Treatment:

Other: Priority Mail

Amazon

Experimental group

Description:

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.

Treatment:

Other: Amazon