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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-07-23

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.

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Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Large Envelope

Intervention Type 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.

Group Type EXPERIMENTAL

Priority Mail

Intervention Type 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.

Group Type EXPERIMENTAL

Amazon

Intervention Type OTHER

Interventions

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Large Envelope

Intervention Type OTHER

Priority Mail

Intervention Type OTHER

Amazon

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No