Recruiting

Diabetes Intervention

Sponsor:

Medical College of Wisconsin

Code:

NCT06279637

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Joint Home-DM-BAT Intervention

Usual Care

Study Details

Brief summary:

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.

Conditions

Type 2 Diabetes

Study ID

NCT06279637

Start date

Mar 4, 2024

Status verified date

Jul, 2025

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Joint Home-DM-BAT Intervention

8 weekly sessions of telephone-delivered, manualized education on diabetes management, problem solving of social needs, and behavioral activation.

Usual Care

Diabetes education materials will be mailed weekly and monthly according to the booster schedule

Primary outcome measure

  • Glycemic Control (Hemoglobin A1C [HbA1C]) [ Time Frame: Change in baseline HbA1C at 6 months post intervention follow-up ]

Central Contacts and Locations

Central contacts

Aprill Z Dawson, PhD, MPH

414-955-8828adawson@mcw.edu

Locations

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Jul 29, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2025-07-29.