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OpenTrials
Completed

NCT Number: NCT02086539

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Large Envelope

Other

Priority Mail

Other

Amazon

Other

Primary outcomes

  1. Enrollment into the Habit Formation study

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Aging (NIA)
  • Rutgers University

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 13, 2014
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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