NCT04857411

Brief Summary

The specific goal of this project is to decrease diabetes-related morbidity among African Americans (AAs) in Milwaukee through the integration of Peers LEAD, a culturally-appropriate program to increase medication adherence into Healthy Living with Diabetes (HLWD), an existing diabetes self-management program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable diabetes-mellitus-type-2

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

Study Start

First participant enrolled

April 19, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2021

Completed
Last Updated

February 14, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

April 22, 2021

Last Update Submit

February 11, 2022

Conditions

Diabetes Mellitus, Type 2

Keywords

Medication adherence

Outcome Measures

Primary Outcomes (7)

  • Mean Hemoglobin A1c

    Participant buddies will have a hemoglobin A1c greater than 8 percent at baseline. will be measured using the A1cNow+ system, the National Glycohemoglobin Standardization Program Certified, CLIA-waived, system that provides results using a finger stick test.

    baseline

  • Mean Hemoglobin A1c

    Participant buddies will have a hemoglobin A1c greater than 8 percent at baseline. will be measured using the A1cNow+ system, the National Glycohemoglobin Standardization Program Certified, CLIA-waived, system that provides results using a finger stick test.

    3 months

  • Mean Hemoglobin A1c

    Participant buddies will have a hemoglobin A1c greater than 8 percent at baseline. will be measured using the A1cNow+ system, the National Glycohemoglobin Standardization Program Certified, CLIA-waived, system that provides results using a finger stick test.

    6 months

  • Mean Systolic Blood Pressure

    Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.

    baseline

  • Mean Systolic Blood Pressure

    Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.

    3 months

  • Mean Systolic Blood Pressure

    Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.

    6 months

  • Change in Diastolic Blood Pressure

    Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.

    baseline, 3 months, 6 months

Secondary Outcomes (9)

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

    baseline, 3 months, 6 months

  • Self-Efficacy for Adherence to Medication Use Scale (SEAMS)

    baseline, 3 months, 6 months

  • Patient's Perceived Involvement in Care Scale (PICS)

    baseline, 3 months, 6 months

  • Diabetes Distress Scale (DDS) 2

    baseline, 3 months, 6 months

  • Patient Health Questionnaire (PHQ-4)

    baseline, 3 months, 6 months

  • +4 more secondary outcomes

Study Arms (1)

Participant 'Buddies'

EXPERIMENTAL

Participants will have an 8-week program initiation phase followed by a maintenance phase through 6-months, supported by Ambassadors.

Behavioral: Peers LEAD plus HLWD

Interventions

Peers LEAD plus HLWDBEHAVIORAL

Combined Peers LEAD and Healthy Living with Diabetes is a culturally-appropriate program to increase medication adherence

Participant 'Buddies'

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identify as AA
  • Can speak/read English
  • Self-report being prescribed one oral or injectable diabetes medication
  • Access to/can use a cellular phone, tablet or computer to join a web-based meeting by video camera during the study period
  • Diagnosed with diabetes for ≥1 year (obtained by self-report or verified by electronic medical record)
  • Will reside in the geographical area throughout the study period
  • Self-reported nonadherence on the Adherence to Refills and Medications Scale for Diabetes (ARMS-D) scale
  • Most recent A1c is ≥8% based on information collected at point of care A1c testing
  • Self-reported adherence on the Adherence to Refills and Medications Scale for Diabetes (ARMS-D) scale
  • Most recent A1c is \<8% based on point of care A1c test
  • Willing to provide support to a Buddy and track phone conversations
  • Willing to attend all training sessions and meetings related to being an Ambassador

You may not qualify if:

  • Diagnosed psychiatric disorder
  • Older than 65-years old with a history of severe hypoglycemia requiring medical assistance or glucagon administration
  • Currently participating in another diabetes lifestyle self-management or medication adherence program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Locations

Milwaukee, Wisconsin, 53202, United States

Location

Related Publications (1)

  • Shiyanbola OO, Maurer M, Schwerer L, Sarkarati N, Wen MJ, Salihu EY, Nordin J, Xiong P, Egbujor UM, Williams SD. A Culturally Tailored Diabetes Self-Management Intervention Incorporating Race-Congruent Peer Support to Address Beliefs, Medication Adherence and Diabetes Control in African Americans: A Pilot Feasibility Study. Patient Prefer Adherence. 2022 Oct 25;16:2893-2912. doi: 10.2147/PPA.S384974. eCollection 2022.

    PMID: 36317056DERIVED

Related Links

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, PhD, B.Pharm

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2021

First Posted

April 23, 2021

Study Start

April 19, 2021

Primary Completion

November 22, 2021

Study Completion

November 22, 2021

Last Updated

February 14, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)