Improving Diabetes Control Through Peer Counseling and Incentives

Diabetes Mellitus Clinical Trial

Official title:

Improving Diabetes Control Through Peer Counseling and Incentives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125956
• Other study ID #: 01164
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: December 2010

Study information

• Verified date: February 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The specific aims of this study are to test whether in a cohort of low-income minority veterans with poor diabetes mellitus (DM) control:

1. Peer counseling is an effective means of reducing HbA1c (a measure of glucose control).

2. Financial incentives are an effective means of reducing HbA1c. This is a randomized controlled pilot study. There will be 3 arms: 1) a control group of poorly controlled diabetics getting usual care; 2) peer counseling with no incentives; and 3) financial incentives without peers. Ultimately, contingent on the success of this intervention, the researchers plan to apply for funding for a large scale intervention employing both peer counseling and incentives to improve DM control in low income and minority patients who are at high risk for premature morbidity and mortality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

• African American veteran

• 50-70 years old

• ICD-9CM diagnosis code consistent with DM (any ICD-9CM code starting with 250)

• For patients: last two HbA1c greater than 8% with at least one measure being within 3 months of enrollment

• For peer counselors: HbA1c of greater than 8% in the past 3 years and an HbA1c less than or equal to 7.5% within 3 months of enrollment

Exclusion Criteria:

• Unstable medical condition that would likely prevent the subject from completing the study

• Patients enrolled in Telehealth will be excluded as such enrollment does not constitute usual care

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Assigned a peer counselor
Dyads will be given $20 per month if they have contact 4 or more times during a month.
• Financial incentives
Participants will be given $100 for reduction of HbA1c by 1 point in a 6 month period and $200 for reduction by 2 points.

Locations

Country	Name	City	State
United States	Philadelphia Veterans Affairs Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	Change in HbA1c from baseline will be the primary outcome measure.	Baseline, 6 months
Secondary	Counts of the number of hypoglycemic events	All events and serious events related to hypoglycemia will be counted over the 6 month intervention period, including emergency room visits and hospitalizations.	6 months
Secondary	Number of peer encounters	The number of peer encounters by arm will be described.	6 months
Secondary	Experience of peer counseling	The experience of peer counseling from both poorly controlled diabetics and counselors will be described.	6 months

External Links

•   LDI Center for Health Incentives
•   This research was supported by a grant from the National Institute on Aging, P30-AG036592. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute on Aging or the NIH
•   VA Center for Health Equity and Promotion (CHERP)