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Completed

NCT Number: NCT04203147

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

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).

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State University of New York at Buffalo

Buffalo, New York, 14203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Supportive Therapy (Control)

Behavioral

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

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.

Primary outcomes

  1. Glycemic Control (HbA1c)

    Time frame: HbA1c at 12 months post intervention follow-up

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

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

HOME DM-BAT: Home-based Diabetes-Modified Behavioral Activation Treatment for Low Income Seniors With T2DM

Acronym: HOME DM-BAT

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Dec 18, 2019
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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