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

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Usual Care; Behavioral: Joint Home-DM-BAT Intervention

• Registration Number: NCT06279637
• Lead Sponsor: Medical College of Wisconsin

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-26
• Study First Posted: 2024-02-28
• Study Start: 2024-03-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	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.
Joint Home-DM-BAT Intervention	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.

Primary Outcome Measures

Name	Time	Method
Glycemic Control (Hemoglobin A1C [HbA1C])	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.

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States