Joint Patient and Caregiver Intervention for Older African Americans With Poorly Controlled Type 2 Diabetes (Joint Home-DM-BAT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Glycemic Control (Hemoglobin A1C [HbA1C])
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief 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.
Investigators
Aprill Z. Dawson, PhD, MPH
Associate Professor
Medical College of Wisconsin
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Glycemic Control (Hemoglobin A1C [HbA1C])
Time Frame: Change in baseline HbA1C at 6 months post intervention follow-up
About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for testing.