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

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT02086539
Collaborator
Rutgers University (Other), National Institute on Aging (NIA) (NIH)
100
Enrollment
1
Location
4
Arms
27.7
Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Large Envelope
  • Other: Priority Mail
  • Other: Amazon
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Other
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
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Jul 23, 2016
Actual Study Completion Date :
Jul 23, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Enrollment into the Habit Formation study [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania
  • Rutgers University
  • National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Kevin G Volpp, MD, PhD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02086539
Other Study ID Numbers:
  • 816003
  • 5R01AG043844-02
First Posted:
Mar 13, 2014
Last Update Posted:
Jun 27, 2017
Last Verified:
Jun 1, 2017

Study Results

No Results Posted as of Jun 27, 2017