Joint Patient and Caregiver Intervention for Older African Americans With Type 2 Diabetes
Recruiting · NCT06279637 · Interventional (participants receive a specific treatment) · Lead sponsor: Medical College of Wisconsin
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
- Caregiver Inclusion Criteria:
- 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.
- Patient/Caregiver
Exclusion criteria
- Mental confusion at screening assessment suggesting significant dementia;
- Alcohol or drug abuse/dependency at screening assessment;
- Active psychosis or acute mental disorder at screening assessment; and
- Life expectancy \<6 months at screening.
Where it is running
1 location listed across 1 US state.
- Medical College of Wisconsin - Milwaukee, Wisconsin, United States