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

NCT02086539 | Completed DMC

• 2 other identifiers: 8160035R01AG043844-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Enrollment into the Habit Formation study

  3 months

Study Arms (4)

Normal Letter

NO INTERVENTION

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.

Large Envelope

EXPERIMENTAL

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

Priority Mail

EXPERIMENTAL

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

Amazon

EXPERIMENTAL

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

Interventions

Large Envelope OTHER

Large Envelope

Priority Mail OTHER

Priority Mail

Amazon OTHER

Amazon

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kevin G Volpp, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: March 13, 2014
• Study Start: April 1, 2014
• Primary Completion: July 23, 2016
• Study Completion: July 23, 2016
• Last Updated: June 27, 2017

Record last verified: 2017-06

Locations

US (1)