NCT04203147

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Supportive Therapy (Control)	Description: 8-weekly sessions of in-home, supportive therapy and monthly booster sessions from months 3-12 via telephone.
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.

Timeline

• Start date: 2020-01-03
• Primary completion: 2025-06-30
• Completion: 2026-01-01
• First posted: 2019-12-18
• Last updated: 2026-02-24
• Results posted: 2026-02-24

Locations

1 site across 1 country: United States