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Improving Diabetes Control Through Peer Counseling and Incentives

Primary Purpose

Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Assigned a peer counselor
Financial incentives
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes, Diabetes mellitus, HbA1c

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Philadelphia Veterans Affairs Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Peer counseling

Financial incentives

Arm Description

This group will receive usual diabetes care through their primary care clinicians.

A peer counselor will be assigned to each participant who currently has good diabetes control but had poor control in the past 3 years.

Patient participants in the financial incentive arm will be given $100 for reduction of HbA1c by 1 point in a 6 month period and $200 for reduction by 2 points.

Outcomes

Primary Outcome Measures

Hemoglobin A1c
Change in HbA1c from baseline will be the primary outcome measure.

Secondary Outcome Measures

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.
Number of peer encounters
The number of peer encounters by arm will be described.
Experience of peer counseling
The experience of peer counseling from both poorly controlled diabetics and counselors will be described.

Full Information

First Posted
May 17, 2010
Last Updated
February 26, 2019
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT01125956
Brief Title
Improving Diabetes Control Through Peer Counseling and Incentives
Official Title
Improving Diabetes Control Through Peer Counseling and Incentives
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
Diabetes, Diabetes mellitus, HbA1c

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will receive usual diabetes care through their primary care clinicians.
Arm Title
Peer counseling
Arm Type
Experimental
Arm Description
A peer counselor will be assigned to each participant who currently has good diabetes control but had poor control in the past 3 years.
Arm Title
Financial incentives
Arm Type
Experimental
Arm Description
Patient participants in the financial incentive arm will be given $100 for reduction of HbA1c by 1 point in a 6 month period and $200 for reduction by 2 points.
Intervention Type
Behavioral
Intervention Name(s)
Assigned a peer counselor
Intervention Description
Dyads will be given $20 per month if they have contact 4 or more times during a month.
Intervention Type
Behavioral
Intervention Name(s)
Financial incentives
Intervention Description
Participants will be given $100 for reduction of HbA1c by 1 point in a 6 month period and $200 for reduction by 2 points.
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Description
Change in HbA1c from baseline will be the primary outcome measure.
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Counts of the number of hypoglycemic events
Description
All events and serious events related to hypoglycemia will be counted over the 6 month intervention period, including emergency room visits and hospitalizations.
Time Frame
6 months
Title
Number of peer encounters
Description
The number of peer encounters by arm will be described.
Time Frame
6 months
Title
Experience of peer counseling
Description
The experience of peer counseling from both poorly controlled diabetics and counselors will be described.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Long, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philadelphia Veterans Affairs Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22431674
Citation
Long JA, Jahnle EC, Richardson DM, Loewenstein G, Volpp KG. Peer mentoring and financial incentives to improve glucose control in African American veterans: a randomized trial. Ann Intern Med. 2012 Mar 20;156(6):416-24. doi: 10.7326/0003-4819-156-6-201203200-00004.
Results Reference
derived
Links:
URL
http://www.med.upenn.edu/ldichi/
Description
LDI Center for Health Incentives
URL
https://www.cherp.research.va.gov/
Description
VA Center for Health Equity and Promotion (CHERP)
URL
https://grants.nih.gov/grants/guide/rfa-files/RFA-AG-09-005.html
Description
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

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Improving Diabetes Control Through Peer Counseling and Incentives

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