- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01125956
Improving Diabetes Control Through Peer Counseling and Incentives
February 26, 2019 updated by: University of Pennsylvania
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Philadelphia Veterans Affairs Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
Participants will be given $100 for reduction of HbA1c by 1 point in a 6 month period and $200 for reduction by 2 points.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hemoglobin A1c
Time Frame: Baseline, 6 months
|
Change in HbA1c from baseline will be the primary outcome measure.
|
Baseline, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
|
Number of peer encounters
Time Frame: 6 months
|
The number of peer encounters by arm will be described.
|
6 months
|
|
Experience of peer counseling
Time Frame: 6 months
|
The experience of peer counseling from both poorly controlled diabetics and counselors will be described.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
- LDI Center for Health Incentives
- VA Center for Health Equity and Promotion (CHERP)
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
May 17, 2010
First Submitted That Met QC Criteria
May 18, 2010
First Posted (Estimate)
May 19, 2010
Study Record Updates
Last Update Posted (Actual)
February 28, 2019
Last Update Submitted That Met QC Criteria
February 26, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01164
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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