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Home-based Diabetes-Modified Behavioral Activation Treatment for Low Income Seniors With T2DM

NCT04203147 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-02-24

Study results available
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Summary

The objective of this protocol is to evaluate the efficacy and cost-effectiveness of 8 sessions of in-home, telephone-delivered, culturally-modified, manualized diabetes-modified, behavioral activation treatment (Home DM-BAT) delivered by trained diabetes nurse educators among low income, ethnic minority seniors with poorly controlled T2DM.

The aims of this randomized controlled efficacy trial are:

Aim: To test the efficacy of Home DM-BAT on glycemic control (hemoglobin A1c).

Hypothesis: Low income, minority seniors with poorly controlled T2DM randomized to Home DM-BAT will have significantly greater improvements in glycemic control (hemoglobin A1c) at 12 months of follow-up compared to the control group (in-home, telephone-delivered supportive therapy - ST).

Conditions

Interventions

BEHAVIORAL

Home DM-BAT

Description: 8-weekly sessions of in-home, culturally-modified, manualized diabetes-modified, behavioral activation treatment (Home DM-BAT) and monthly booster sessions from months 3-12 via telephone.

BEHAVIORAL

Supportive Therapy (Control)

Description: 8-weekly sessions of in-home, supportive therapy and monthly booster sessions from months 3-12 via telephone.

Sponsors & Collaborators

  • State University of New York at Buffalo

    lead OTHER

Principal Investigators

  • Leonard E Egede, MD, MS · State University of New York at Buffalo

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-03
Primary Completion
2025-06-30
Completion
2026-01-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04203147 on ClinicalTrials.gov