Joint Patient and Caregiver Intervention for Older African Americans With Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Joint Home-DM-BAT Intervention, Usual Care.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: 50 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Joint Patient and Caregiver Intervention for Older African Americans With Poorly Controlled Type 2 Diabetes (Joint Home-DM-BAT)
Overview
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
- Behavioral Joint Home-DM-BAT Intervention
8 weekly sessions of telephone-delivered, manualized education on diabetes management, problem solving of social needs, and behavioral activation. - Behavioral Usual Care
Diabetes education materials will be mailed weekly and monthly according to the booster schedule
Primary outcome measures
- Glycemic Control (Hemoglobin A1C [HbA1C]) [Time frame: Change in baseline HbA1C at 6 months post intervention follow-up]
Eligibility criteria
Patient 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Medical College of Wisconsin — Milwaukee
Identifiers
NCT: NCT06279637 · PRO00046457