Peers EXCEL Trial to Improve Glycemic Control

Type 2 Diabetes Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05527847
• Other study ID #: 2022-0879
• Secondary ID: A561000PHARM/PHA
• Status: Completed
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: November 14, 2023

Study information

• Verified date: November 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 14, 2023
• Est. primary completion date: October 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood glucose (hemoglobin A1C)	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	Medication adherence	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
Secondary	Feasibility of intervention	Participants will complete validated surveys to assess diabetes-health beliefs, patient self-efficacy/activation, and patient-provider communication quality.	Baseline, 2 months, 6 months
Secondary	Acceptability of intervention	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
Secondary	Adherence to Refills and Medicines Scale for Diabetes (ARMS-D) Score	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