Joint Patient and Caregiver Intervention for Older African Americans With Type 2 Diabetes
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Mar 2024
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2024
CompletedFirst Posted
Study publicly available on registry
February 28, 2024
CompletedStudy Start
First participant enrolled
March 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
July 29, 2025
July 1, 2025
2.4 years
February 19, 2024
July 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Glycemic Control (Hemoglobin A1C [HbA1C])
About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for testing.
Change in baseline HbA1C at 6 months post intervention follow-up
Study Arms (2)
Joint Home-DM-BAT Intervention
EXPERIMENTALA trained health educator will deliver the manualized Joint Home-DM-BAT intervention. Participants will receive 8-weekly sessions of diabetes education, problem solving around social needs, and behavioral activation via telephone; and 3 monthly booster sessions.
Usual Care
ACTIVE COMPARATORPatients randomized to the usual care arm will receive weekly mailings of diabetes education modules for 8 weeks and monthly mailings for 3 months to match the weekly and monthly booster sessions.
Interventions
8 weekly sessions of telephone-delivered, manualized education on diabetes management, problem solving of social needs, and behavioral activation.
Diabetes education materials will be mailed weekly and monthly according to the booster schedule
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 19, 2024
First Posted
February 28, 2024
Study Start
March 4, 2024
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
July 29, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share