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

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

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 Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Other: Large Envelope; Other: Priority Mail; Other: Amazon

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Other: Large Envelope
Experimental: 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.	Other: Priority Mail
Experimental: 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.	Other: Amazon

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute on Aging (NIA); Rutgers University
• Investigators: Principal Investigator: Kevin G Volpp, MD, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): July 23, 2016
• Study Completion (Actual): July 23, 2016

Study Registration Dates

• First Submitted: March 11, 2014
• First Submitted That Met QC Criteria: March 11, 2014
• First Posted (Estimate): March 13, 2014

Study Record Updates

• Last Update Posted (Actual): June 27, 2017
• Last Update Submitted That Met QC Criteria: June 26, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 816003; 5R01AG043844-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No