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NCT Number: NCT06279637

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

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.

Recruiting

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Key information

Age range

50 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location status: Recruiting

Location contact

Aprill Dawson

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patient Inclusion Criteria:

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

Caregiver Inclusion Criteria:

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

Patient/Caregiver Exclusion Criteria:

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

Treatment and study plan

Joint Home-DM-BAT Intervention

Behavioral

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

Usual Care

Behavioral

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aprill Z Dawson, PhD, MPH

CONTACT

[email protected]

414-955-8828

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2024
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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