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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 120
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
United States
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Aprill Z Dawson, PhD, MPH
adawson@mcw.edu
414-955-8828
Time Frame
Start Date: 2024-03-04
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Medical College of Wisconsin

This content was sourced from clinicaltrials.gov