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

Last updated: February 19, 2026
Sponsor: State University of New York at Buffalo
Overall Status: Completed

Phase

N/A

Condition

Diabetes Prevention

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Treatment

Supportive Therapy (Control)

Home DM-BAT

Clinical Study ID

NCT04203147
1R01DK118038-01A1
  • Ages > 65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age >=65 years of age;

  2. Self-identified as Black/African American or Hispanic;

  3. Clinical diagnosis of T2DM verified by an HbA1c >=8% at the screening assessment;

  4. Able to communicate in English or Spanish; and

  5. Resident of independent, subsidized, assisted senior housing facility or communitydwelling elderly adults in the greater Milwaukee area and surrounding counties thathave high African American/Hispanic populations.

Exclusion

Exclusion Criteria:

  1. Mental confusion at screening assessment suggesting significant dementia;

  2. Participation in other diabetes research;

  3. Alcohol or drug abuse/dependency;

  4. Active psychosis or acute mental disorder; and

  5. Life expectancy <12 months at screening assessment.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Supportive Therapy (Control)
Phase:
Study Start date:
January 03, 2020
Estimated Completion Date:
January 01, 2026

Study Description

Study Overview. Two hundred participants will be randomized 1:1 to Home DM-BAT (n=100) or the control condition (n=100) to control for attention. The intervention includes 8 weekly intervention sessions and 10 monthly booster sessions. Primary analyses will be conducted at 12 months post-randomization.

Description of the Home DM-BAT Intervention: A trained nurse educator will deliver the manualized Home DM-BAT intervention via telephone. Subjects will receive 8-weekly sessions of behavioral activation and monthly booster sessions from months 3-12. All intervention sessions will be delivered by telephone and will include a previously tested diabetes education/skills training intervention based on ADA guidelines, diabetes-tailored behavioral activation and will address social determinant of health issues.

Control Group (GHE+ST): Patients randomized to the control group will receive in-home, telephone-delivered 8-weekly sessions of combined general health education (GHE) and supportive therapy (ST) and monthly booster sessions from months 3-12 to match the intervention group for both content and attention. The control group will not receive diabetes education, address social determinants of health, or behavioral activation.

Connect with a study center

  • State University of New York at Buffalo

    Buffalo 5110629, New York 5128638 14203
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.