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OpenTrials
Completed

NCT Number: NCT01125956

Improving Diabetes Control Through Peer Counseling and Incentives

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Philadelphia Veterans Affairs Medical Center

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

  • 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

Treatment and study plan

Assigned a peer counselor

Behavioral

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

Financial Incentives

Behavioral

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 outcomes

  1. Hemoglobin A1c

    Time frame: Baseline, 6 months

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

Secondary outcomes

  1. Counts of the number of hypoglycemic events

    Time frame: 6 months

    All events and serious events related to hypoglycemia will be counted over the 6 month intervention period, including emergency room visits and hospitalizations.

  2. Number of peer encounters

    Time frame: 6 months

    The number of peer encounters by arm will be described.

  3. Experience of peer counseling

    Time frame: 6 months

    The experience of peer counseling from both poorly controlled diabetics and counselors will be described.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 19, 2010
Registry last updated
Feb 28, 2019

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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