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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086539
• Other study ID #: 816003
• Secondary ID: 5R01AG043844-02
• Status: Completed
• Phase: N/A
• First received: March 11, 2014
• Last updated: June 26, 2017
• Start date: April 2014
• Est. completion date: July 23, 2016

Study information

• Verified date: June 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 23, 2016
• Est. primary completion date: July 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Other:
• Large Envelope

• Priority Mail

• Amazon

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Aging (NIA), Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment into the Habit Formation study		3 months