NCT01125956

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:

  1. 1.Peer counseling is an effective means of reducing HbA1c (a measure of glucose control).
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

1.4 years

First QC Date

May 17, 2010

Last Update Submit

February 26, 2019

Conditions

Keywords

DiabetesDiabetes mellitusHbA1c

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

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

    Baseline, 6 months

Secondary Outcomes (3)

  • Counts of the number of hypoglycemic events

    6 months

  • Number of peer encounters

    6 months

  • Experience of peer counseling

    6 months

Study Arms (3)

Control

NO INTERVENTION

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

Peer counseling

EXPERIMENTAL

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

Behavioral: Assigned a peer counselor

Financial incentives

EXPERIMENTAL

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.

Behavioral: Financial incentives

Interventions

Dyads will be given $20 per month if they have contact 4 or more times during a month.

Peer counseling

Participants will be given $100 for reduction of HbA1c by 1 point in a 6 month period and $200 for reduction by 2 points.

Financial incentives

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African American veteran
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philadelphia Veterans Affairs Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Judith Long, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2010

First Posted

May 19, 2010

Study Start

July 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 28, 2019

Record last verified: 2019-02

Locations