NCT05527847

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

February 13, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

8 months

First QC Date

September 1, 2022

Last Update Submit

November 16, 2023

Conditions

Type 2 Diabetes

Keywords

African-Americanmedication adherencediabetes self-management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Medication adherence

    Baseline, 2 months, 6 months

  • Feasibility of intervention

    Baseline, 2 months, 6 months

  • Acceptability of intervention

    Baseline, 2 months, 6 months

  • Adherence to Refills and Medicines Scale for Diabetes (ARMS-D) Score

    Baseline, 2 months, 6 months

Study Arms (2)

Healthy Living with Diabetes (HLWD)

ACTIVE COMPARATOR

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

Peers EXCEL

EXPERIMENTAL

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

Behavioral: Peers LEADBehavioral: HLWD

Interventions

Peers LEADBEHAVIORAL

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.

Peers EXCEL
HLWDBEHAVIORAL

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

Healthy Living with Diabetes (HLWD)Peers EXCEL

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Medication Adherence

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Olayinka Shiyanbola, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 6, 2022

Study Start

February 13, 2023

Primary Completion

October 2, 2023

Study Completion

November 14, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)