Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Trial of Incentives and Peer Mentors to Improve Diabetic Outcomes

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Pennsylvania
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01125969
First received: April 13, 2010
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

In recent years, social networks have garnered attention in both academic journals and the lay press because of strong associations demonstrated in retrospective studies between social networks and incidence of major health problems such as obesity and smoking. Financial incentives have also been demonstrated to improve health behaviors in obesity, smoking, and medication adherence. We propose to conduct a randomized controlled trial among a predominantly African American population with persistently poor diabetes mellitus (DM) control to examine whether two novel interventions, lottery based financial incentives and telephone based one-on-one peer mentoring (the 'buddy system'), can significantly ameliorate disparities in poor DM control.

The intervention is based on epidemiologic evidence, randomized controlled trials, and pilot studies demonstrating: 1) Lottery based financial incentives are a powerful motivator of behavior change; 2) One-on-one peer mentoring is a flexible, cost-efficient means of increasing DM specific social support and may be particularly salient in minority communities; and 3) Matching patients with poorly controlled DM with a similar individual from their community who has gained control of their DM draws on existing community assets in creating an inherently culturally competent intervention. DM patients with poor DM control will be randomized to 1 of 4 arms: usual care; telephone based one-on-one peer mentoring; lottery based financial incentives; and peer mentoring plus financial incentives.

The Specific Aims are to test: 1) The effectiveness of telephone based one-on-one peer mentoring in improving glycemic control relative to usual care; 2) The effectiveness of lottery based financial incentives in improving glycemic control relative to usual care; 3) The effectiveness of combining peer mentoring and financial incentives relative to control; and 4) The relative cost effectiveness of all four approaches. In exploratory analyses, we will examine whether African American patients enrolled in intervention arms have greater improvement in glycemic control than white patients, whether intervention group patients experience greater improvements in blood pressure (BP) and lipid control, and whether peer mentors experience improvements in their own health. We will pair mentors with mentees based on race, gender, age, and disease severity. The active intervention will be run for a 6-month time period, with participants followed for an additional 6 months to determine if effects persist post intervention.

The proposed interventions address multiple barriers to effective disease management common among patients with DM. If effective, these interventions could provide important models for improving glycemic control in general and, in particular, for addressing racial disparities in DM outcomes.


Condition Intervention Phase
Diabetes Mellitus
Behavioral: Incentives
Behavioral: Education
Behavioral: Peer mentoring
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Trial of Incentives and Peer Mentors to Improve Diabetic Outcomes

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    HbA1c is a measure of the percent of glycosylated hemoglobin in the blood stream. It is an excellent biomarker reflecting glucose control for the preceding 2-3 months and thus provides a reliable and unbiased marker of patient adherence. The primary outcome will be a change in HbA1c from baseline to the 6-month follow-up visit.


Secondary Outcome Measures:
  • Cost-effectiveness of change in Hemoglobin A1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    A "within-trial" analysis will be conducted that adopts the perspective of an insurer and directly compares costs and change in HbA1c using data measured in the trial.


Estimated Enrollment: 240
Study Start Date: March 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Behavioral: Education
Standard brochure about improving blood sugar control plus warnings about dangers of persistently high sugars and hypoglycemia
Experimental: Incentive Behavioral: Incentives
Incentives will be offered for checking blood glucose each morning and for control of blood glucose (between 80-140 mg/dL).
Behavioral: Education
Standard brochure about improving blood sugar control plus warnings about dangers of persistently high sugars and hypoglycemia
Experimental: Peer Mentoring Behavioral: Education
Standard brochure about improving blood sugar control plus warnings about dangers of persistently high sugars and hypoglycemia
Behavioral: Peer mentoring
Participant is assigned a peer mentor who is matched on gender, race and age and who achieved good glucose control after previously having poor glucose control.
Experimental: Incentives and Peer Mentoring Behavioral: Incentives
Incentives will be offered for checking blood glucose each morning and for control of blood glucose (between 80-140 mg/dL).
Behavioral: Education
Standard brochure about improving blood sugar control plus warnings about dangers of persistently high sugars and hypoglycemia
Behavioral: Peer mentoring
Participant is assigned a peer mentor who is matched on gender, race and age and who achieved good glucose control after previously having poor glucose control.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed with diabetes mellitus
  • 30 to 70 years old
  • persistently poor glucose control, defined as having the last two HbA1c values > 8%, with at least one measure within 3 months of enrollment
  • receiving treatment for diabetes mellitus at one of five University of Pennsylvania outpatient clinics

Exclusion Criteria:

  • does not speak English
  • unable to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125969

Contacts
Contact: Brittany Lawson 215-573-9961 blaws@mail.med.upenn.edu
Contact: Sarah Windawi 215-573-9720 swindawi@upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Judith A. Long, MD         
Sponsors and Collaborators
University of Pennsylvania
University of Michigan
Investigators
Principal Investigator: Judith A. Long, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01125969     History of Changes
Other Study ID Numbers: 10022605
Study First Received: April 13, 2010
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
diabetes
glucose
peer mentor
incentives
behavioral economics
cost-effectiveness

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 27, 2014