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Clinical Trials/NCT02086539
NCT02086539
Completed
Not Applicable

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

University of Pennsylvania1 site in 1 country100 target enrollmentApril 2014
ConditionsDiabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes
Sponsor
University of Pennsylvania
Enrollment
100
Locations
1
Primary Endpoint
Enrollment into the Habit Formation study
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
July 23, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Enrollment into the Habit Formation study

Time Frame: 3 months

Study Sites (1)

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