Joint Patient and Caregiver Intervention for Older African Americans With Type 2 Diabetes

July 25, 2025 updated by: Aprill Z. Dawson, PhD, MPH, Medical College of Wisconsin

Joint Patient and Caregiver Intervention for Older African Americans With Poorly Controlled Type 2 Diabetes (Joint Home-DM-BAT)

This study will test the preliminary efficacy of a joint patient/informal caregiver telephone-delivered intervention that includes diabetes education; problem solving around social needs; and behavioral activation for older African Americans with poorly controlled type 2 diabetes by randomizing 100 patient/caregiver dyads to the Joint Home intervention (n=50) and usual care (n=50) arms.

The aims of the study are:

Aim 1: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on patient clinical outcomes (hemoglobin A1c, blood pressure, and LDL-Cholesterol).

Aim 2: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) Joint Home DM-BAT on patient quality of life.

Aim 3: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on caregiver quality of life and caregiver burden.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Aprill Z Dawson, PhD, MPH
  • Phone Number: 414-955-8828
  • Email: adawson@mcw.edu

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Aprill Dawson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Patient Inclusion Criteria:

  1. Age ≥50 years of age;
  2. Self-identified as Black/African American;
  3. Clinical diagnosis of T2DM and poorly controlled, defined as HbA1c ≥8% at the screening visit;
  4. Able to communicate in English; and
  5. Has an informal caregiver (family member or close friend willing to participate in the study for 6 months.

Caregiver Inclusion Criteria:

  1. Willing to attend 4, one-hour sessions with the study participant;
  2. Willing to support the study participant for study duration (6 months); and
  3. Willing to complete brief baseline, 3- and 6-month assessments.

Patient/Caregiver Exclusion Criteria:

  1. Mental confusion at screening assessment suggesting significant dementia;
  2. Alcohol or drug abuse/dependency at screening assessment;
  3. Active psychosis or acute mental disorder at screening assessment; and
  4. Life expectancy <6 months at screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Joint Home-DM-BAT Intervention
A trained health educator will deliver the manualized Joint Home-DM-BAT intervention. Participants will receive 8-weekly sessions of diabetes education, problem solving around social needs, and behavioral activation via telephone; and 3 monthly booster sessions.
Behavioral: Joint Home-DM-BAT Intervention
8 weekly sessions of telephone-delivered, manualized education on diabetes management, problem solving of social needs, and behavioral activation.
Active Comparator: Usual Care
Patients randomized to the usual care arm will receive weekly mailings of diabetes education modules for 8 weeks and monthly mailings for 3 months to match the weekly and monthly booster sessions.
Behavioral: Usual Care
Diabetes education materials will be mailed weekly and monthly according to the booster schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic Control (Hemoglobin A1C [HbA1C])
Time Frame: Change in baseline HbA1C at 6 months post intervention follow-up
About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for testing.
Change in baseline HbA1C at 6 months post intervention follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2025

Last Update Submitted That Met QC Criteria

July 25, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00046457

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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