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Improving Diabetes Control Through Peer Counseling and Incentives

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ClinicalTrials.gov Identifier: NCT01125956
Recruitment Status : Completed
First Posted : May 19, 2010
Last Update Posted : August 15, 2012
Sponsor:
Information provided by (Responsible Party):
Sarah Windawi, University of Pennsylvania

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. 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: Assigned a peer counselor Behavioral: Financial incentives Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Diabetes Control Through Peer Counseling and Incentives
Study Start Date : July 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
No Intervention: Control
This group will receive usual diabetes care through their primary care clinicians.
Experimental: Peer counseling
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
Dyads will be given $20 per month if they have contact 4 or more times during a month.

Experimental: Financial incentives
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
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 Measures :
  1. Hemoglobin A1c [ Time Frame: Baseline, 6 months ]
    Change in HbA1c from baseline will be the primary outcome measure.


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125956


Locations
United States, Pennsylvania
Philadelphia Veterans Affairs Medical Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Judith Long, MD University of Pennsylvania

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sarah Windawi, Project Manager, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01125956     History of Changes
Other Study ID Numbers: 01164
First Posted: May 19, 2010    Key Record Dates
Last Update Posted: August 15, 2012
Last Verified: August 2012

Keywords provided by Sarah Windawi, University of Pennsylvania:
Diabetes
Diabetes mellitus
HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases