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

RecruitingNAAges 50 Years - 120 YearsAllMedical College of Wisconsin
NCT06279637 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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) o

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📋 Eligibility rules (as published)
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.
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What it tests

  • Joint Home-DM-BAT Intervention
  • Usual Care
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Where

1 site
Medical College of Wisconsin
Milwaukee, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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