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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06279637
• Other study ID #: PRO00046457
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 4, 2024
• Est. completion date: July 2026

Study information

• Verified date: February 2024
• Source: Medical College of Wisconsin
• Contact: Aprill Z Dawson, PhD, MPH
• Phone: 414-955-8828
• Email: adawson[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.
• Usual Care
Diabetes education materials will be mailed weekly and monthly according to the booster schedule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Control (Hemoglobin A1C [HbA1C])	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