Home-Based Behavioral Therapy for Type 2 Diabetes (HOME DM-BAT Trial)

Palo Alto (17 mi)

Overseen byLeonard Egede, MD

Age: 65+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: State University of New York at Buffalo

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests a telephone-based support program for low-income, ethnic minority seniors with poorly controlled diabetes. The program aims to improve their health by educating them about diabetes, promoting healthy behaviors, and addressing social challenges.

Eligibility Criteria

This trial is for low-income seniors aged 65 or older with poorly controlled Type 2 Diabetes (T2DM), specifically those who are Black/African American or Hispanic, living in Milwaukee area senior housing or communities. Participants must have an HbA1c level of at least 8% and be able to communicate in English or Spanish. Those with active psychosis, severe mental disorders, substance abuse issues, participation in other diabetes studies, significant dementia, or a life expectancy under one year cannot join.

Treatment Details

The study tests Home DM-BAT—a culturally-tailored home and phone-based intervention by nurse educators—against supportive therapy control. It aims to improve clinical outcomes like blood sugar levels (hemoglobin A1c), blood pressure, cholesterol; behavioral aspects such as glucose monitoring, dieting habits; exercise routines; medication adherence; and overall quality of life over a period of 12 months.

2Treatment groups

Experimental Treatment

Active Control

Group I: Home DM-BAT InterventionExperimental Treatment1 Intervention

A trained nurse educator will deliver the manualized Home DM-BAT intervention. Subjects will receive 8-weekly sessions of behavioral activation and monthly booster sessions from months 3-12 via telephone.

Group II: Control Group (GHE+ST)Active Control1 Intervention

Patients randomized to the control group will receive in-home 8-weekly sessions of combined general health education (GHE) and supportive therapy (ST) and monthly booster sessions from months 3-12 via telephone.