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Completed

NCT Number: NCT01125969

A Trial of Incentives and Peer Mentors to Improve Diabetic Outcomes

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.

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Key information

Age range

30 year–70 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

  • 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

Treatment and study plan

Incentives

Behavioral

Incentives will be offered for checking blood glucose each morning and for control of blood glucose (between 80-140 mg/dL).

Education

Behavioral

Standard brochure about improving blood sugar control plus warnings about dangers of persistently high sugars and hypoglycemia

Peer Mentoring

Behavioral

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.

Primary outcomes

  1. Hemoglobin A1c

    Time frame: Baseline, 6 months

    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 outcomes

  1. Cost-effectiveness of change in Hemoglobin A1c

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • University of Michigan

Registry information

Official study title

A Randomized Trial of Incentives and Peer Mentors to Improve Diabetic Outcomes

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
May 19, 2010
Registry last updated
Aug 7, 2018

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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