Improving Diabetes Control Through Peer Counseling and Incentives

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sarah Windawi, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01125956
First received: May 17, 2010
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Diabetes Mellitus
Behavioral: Assigned a peer counselor
Behavioral: Financial incentives
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Diabetes Control Through Peer Counseling and Incentives

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Change in HbA1c from baseline will be the primary outcome measure.


Secondary Outcome Measures:
  • Counts of the number of hypoglycemic events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The number of peer encounters by arm will be described.

  • Experience of peer counseling [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The experience of peer counseling from both poorly controlled diabetics and counselors will be described.


Estimated Enrollment: 160
Study Start Date: July 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided by University of Pennsylvania

Additional 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
Study First Received: May 17, 2010
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Diabetes
Diabetes mellitus
HbA1c

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

ClinicalTrials.gov processed this record on July 28, 2014