A Trial of Incentives and Peer Mentors to Improve Diabetic Outcomes
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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 |
- 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 non-gameable marker of patient adherence. The primary outcome will be a change in HbA1c from baseline to the 6-month follow-up visit.
- 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 |
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| Contact: Brittany Lawson | 215-573-9961 | blaws@mail.med.upenn.edu |
| Contact: Sarah Windawi | 215-573-9720 | swindawi@upenn.edu |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: Judith A. Long, MD | |
| 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: | December 19, 2012 |
| 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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013