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

NCT04203147 | Completed Results DMC

• 1 other identifier: 1R01DK118038-01A1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Glycemic Control (HbA1c)

  About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for HbA1c.

  HbA1c at 12 months post intervention follow-up

Study Arms (2)

Home DM-BAT Intervention

EXPERIMENTAL

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.

Behavioral: Home DM-BAT

Control Group (GHE+ST)

ACTIVE COMPARATOR

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.

Behavioral: Supportive Therapy (Control)

Interventions

Supportive Therapy (Control) BEHAVIORAL

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

Control Group (GHE+ST)

Home DM-BAT BEHAVIORAL

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.

Home DM-BAT Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \>=65 years of age;
• Self-identified as Black/African American or Hispanic;
• Clinical diagnosis of T2DM verified by an HbA1c \>=8% at the screening assessment;
• Able to communicate in English or Spanish; and
• Resident of independent, subsidized, assisted senior housing facility or community dwelling elderly adults in the greater Milwaukee area and surrounding counties that have high African American/Hispanic populations.

You may not qualify if:

• Mental confusion at screening assessment suggesting significant dementia;
• Participation in other diabetes research;
• Alcohol or drug abuse/dependency;
• Active psychosis or acute mental disorder; and
• Life expectancy \<12 months at screening assessment.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

State University of New York at Buffalo

Buffalo, New York, 14203, United States

Location

Related Publications (1)

• Egede LE, Davidson TM, Knapp RG, Walker RJ, Williams JS, Dismuke CE, Dawson AZ. HOME DM-BAT: home-based diabetes-modified behavioral activation treatment for low-income seniors with type 2 diabetes-study protocol for a randomized controlled trial. Trials. 2021 Nov 8;22(1):787. doi: 10.1186/s13063-021-05744-1.

  PMID: 34749788 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Principal Investigator
• Organization: SUNY at Buffalo

jstooks@buffalo.edu

716-829-2364

Study Officials

• Leonard E Egede, MD, MS

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Professor & Chair, Department of Medicine

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 18, 2019
• Study Start: January 3, 2020
• Primary Completion: June 30, 2025
• Study Completion: January 1, 2026
• Last Updated: February 24, 2026
• Results First Posted: February 24, 2026

Record last verified: 2026-02

Locations

US (1)