Type 2 Diabetes
Conditions
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.
Interventions
BEHAVIORALJoint Home-DM-BAT Intervention
8 weekly sessions of telephone-delivered, manualized education on diabetes management, problem solving of social needs, and behavioral activation.
BEHAVIORALUsual Care
Diabetes education materials will be mailed weekly and monthly according to the booster schedule
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 120 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control (Hemoglobin A1C [HbA1C]) | 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. |
Countries
United States
Contacts
Primary ContactAprill Z Dawson, PhD, MPH
Outcome results
None listed