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

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT06279637
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Mar 4, 2024
Status verified
Jul 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical College of WisconsinMilwaukeeWisconsin53226
Aprill Dawson

Find similar trials in Milwaukee, WI

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Medical College of Wisconsin· Milwaukee, WI

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