Improving Diabetes Control Through Peer Counseling and Incentives
This study has been completed.
Sponsor:
University of Pennsylvania
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
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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:
- 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.
| 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
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 May 23, 2013