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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02086539
Enrollment
100
Registered
2014-03-13
Start date
2014-04-30
Completion date
2016-07-23
Last updated
2017-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

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.

Interventions

OTHERLarge Envelope
OTHERPriority Mail
OTHERAmazon

Sponsors

Rutgers University
CollaboratorOTHER
National Institute on Aging (NIA)
CollaboratorNIH
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
Enrollment into the Habit Formation study3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026