Peers EXCEL Trial to Improve Glycemic Control

NCT ID: NCT05527847

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-13

Study Completion Date

2023-11-14

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

HLWD

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Peers LEAD

Intervention Type 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

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olayinka Shiyanbola, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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A561000

Identifier Type: OTHER

Identifier Source: secondary_id

PHARM/PHARMACY

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 02/20/2023

Identifier Type: OTHER

Identifier Source: secondary_id

2022-0879

Identifier Type: -

Identifier Source: org_study_id

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