Peers EXCEL Trial to Improve Glycemic Control

University of Wisconsin (UW)

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: Peers LEAD; Behavioral: HLWD

Study type: Interventional

Funder types: Other

Identifiers

NCT05527847

Protocol Version 02/20/2023 (Other Identifier)

2022-0879

PHARM/PHARMACY (Other Identifier)

A561000 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Healthy Living with Diabetes (HLWD)

Active Comparator group

Description:

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.

Treatment:

Behavioral: HLWD

Peers EXCEL

Experimental group

Description:

Participants will have an 8-week self-management program, and will participate in phone calls with a peer for the remaining 4 months.

Treatment:

Behavioral: HLWD

Behavioral: Peers LEAD