NCT06279637 Joint Patient and Caregiver Intervention for Older African Americans With Type 2 Diabetes
| NCT ID | NCT06279637 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical College of Wisconsin |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-03-04 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-03-04 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06279637 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 120 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06279637 currently recruiting?
Yes, NCT06279637 is actively recruiting participants. Contact the research team at adawson@mcw.edu for enrollment information.
Where is the NCT06279637 trial being conducted?
This trial is being conducted at Milwaukee, United States.
Who is sponsoring the NCT06279637 clinical trial?
NCT06279637 is sponsored by Medical College of Wisconsin. The trial plans to enroll 100 participants.
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