Peers EXCEL Trial to Improve Glycemic Control

November 16, 2023 updated by: University of Wisconsin, Madison

A Pilot Randomized Clinical Trial (RCT) to Examine the Benefits of a Culturally Adapted Peer Support and Self-Management Intervention to Improve Glycemic Control in African Americans

The purpose of the study is to gather input about the value of adding a newly developed diabetes self-management program to an existing diabetes self-management program. Participants will self-identify as African-American/Black with type 2 diabetes, and prescribed a diabetes medication. Participants can expect to be in the study for 6 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Both programs utilized in this study focus on topics such as diet, exercise, and stress. Both programs offer ideas to manage diabetes symptoms, discuss appropriate exercises, provide guidance on healthy eating, review the use of medicine, and offer tips on communicating with healthcare providers and voicing concerns to family members.

The new program is culturally-tailored for African Americans and focuses on helping patients take their medicines as prescribed.

The purpose of this research study is to evaluate this newly developed combined diabetes self-management program.

Study Type

Interventional

Enrollment (Actual)

14

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

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Between 18-90 years old
  • Self-identify as African-American
  • Diagnosis of Type 2 diabetes
  • Able to speak/read English
  • Self-report having a primary care provider who prescribes one diabetes medication
  • Diagnosed with diabetes for ≥1 year at point of care
  • Will reside in the geographical area throughout the study period
  • Self-reported nonadherence on the DOSE-nonadherence survey
  • ≥7.5% A1C

Exclusion Criteria:

  • Self-reported bipolar or personality disorders, schizophrenia, Alcohol and Other Drug Abuse (AODA), dementia
  • Older adults who have a history of severe hypoglycemia requiring medical assistance or glucagon administration
  • Participating in another lifestyle or medication adherence program

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy Living with Diabetes (HLWD)
Participants will have a 6-week self-management program, followed by the option to work with a Community Health Worker for the remaining 4 months.
Behavioral: HLWD
Weekly group sessions for two months. Sessions will last up to 2.5 hours and focus on a different diabetes self-management topic.
Experimental: Peers EXCEL
Participants will have an 8-week self-management program, and will participate in phone calls with a peer for the remaining 4 months.
Behavioral: HLWD
Weekly group sessions for two months. Sessions will last up to 2.5 hours and focus on a different diabetes self-management topic.
Behavioral: Peers LEAD
Two group session focusing on beliefs about medicines and diabetes, discrimination/mistrust, and communication with providers, and 2 peer-based phone calls from Ambassadors to occur weekly for weeks 3-8, then bi-weekly for weeks 9-12.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood glucose (hemoglobin A1C)
Time Frame: Baseline, 2 months, 6 months
The hypothesis is that there will be a more significant change in mean A1C, which is clinically meaningful, for participants in Peers EXCEL as compared to those in HLWD.
Baseline, 2 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of intervention
Time Frame: Baseline, 2 months, 6 months
Participants will complete validated surveys to assess diabetes-health beliefs, patient self-efficacy/activation, and patient-provider communication quality.
Baseline, 2 months, 6 months
Acceptability of intervention
Time Frame: Baseline, 2 months, 6 months
Interviews and focus groups will be conducted with participants, ambassadors and HLWD leaders respectively to get feedback on their intervention experiences.
Baseline, 2 months, 6 months
Adherence to Refills and Medicines Scale for Diabetes (ARMS-D) Score
Time Frame: Baseline, 2 months, 6 months
The ARMS-D has a total possible range of scores from 11-44, with higher scores indicating increased problems with medication adherence.
Baseline, 2 months, 6 months
Medication adherence
Time Frame: Baseline, 2 months, 6 months
The hypothesis is that there will be higher medication adherence for participants in Peers EXCEL as compared to those in HLWD. Self-reported medication adherence is measured using the 3-item Extent of Nonadherence domain in the Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence) survey. This measure screens for nonadherence and is calculated by computing the mean of the 3 items (range of score is 1-5). Mean scores of 3 (i.e., scoring "1" on each of the 3 items) will be classified as nonadherent, while all mean scores >3 will be classified as adherent.
Baseline, 2 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Olayinka Shiyanbola, MD, University of Wisconsin, Madison

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 (Actual)

February 13, 2023

Primary Completion (Actual)

October 2, 2023

Study Completion (Actual)

November 14, 2023

Study Registration Dates

First Submitted

September 1, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 6, 2022

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-0879
  • A561000 (Other Identifier: UW Madison)
  • PHARM/PHARMACY (Other Identifier: UW Madison)
  • Protocol Version 02/20/2023 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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