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NCT Number: NCT05527847

Peers EXCEL Trial to Improve Glycemic Control

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.

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Key information

Conditions

Type 2 Diabetes Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Medication Adherence Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peers LEAD

Behavioral

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.

HLWD

Behavioral

Weekly group sessions for two months. Sessions will last up to 2.5 hours and focus on a different diabetes self-management topic.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 6, 2022
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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