Joint intervention for older African Americans with type 2 diabetes and their caregivers
Joint Patient and Caregiver Intervention for Older African Americans With Poorly Controlled Type 2 Diabetes (Joint Home-DM-BAT)
This study is testing a phone-based program to see if it can help older African Americans with type 2 diabetes and their caregivers manage their health better than usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 50 Years to 120 Years |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT06279637 on ClinicalTrials.gov |
What this trial studies
This study tests the effectiveness of a telephone-delivered intervention designed for older African Americans with poorly controlled type 2 diabetes and their informal caregivers. It involves randomizing 100 patient/caregiver pairs into two groups: one receiving the Joint Home intervention, which includes diabetes education and support, and the other receiving usual care. The study aims to evaluate improvements in clinical outcomes such as hemoglobin A1c levels, blood pressure, and LDL cholesterol, as well as the quality of life for both patients and caregivers over a six-month period.
Who should consider this trial
Good fit: Ideal candidates are African American individuals aged 50 and older with poorly controlled type 2 diabetes and an informal caregiver willing to participate.
Not a fit: Patients with significant mental confusion, substance abuse issues, or a life expectancy of less than six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve diabetes management and quality of life for older African Americans and their caregivers.
How similar studies have performed: Other studies have shown promise in similar interventions targeting diabetes management in older populations, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milwaukee, Wisconsin
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Aprill Z Dawson, PhD, MPH
- Email: adawson@mcw.edu
- Phone: 414-955-8828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.