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

Part of paid clinical trials in Buffalo, New York.

Sponsor
State University of New York at Buffalo
Study ID
NCT04203147
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

First listed
Dec 18, 2019
Start date
Jan 3, 2020
Status verified
Feb 2026
Primary completion
Jun 30, 2025
Completion
Jan 1, 2026

Study Design

Enrollment
200 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Home DM-BAT Intervention
    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.
  • Active Comparator: Control Group (GHE+ST)
    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.

Primary Outcome Measure

Glycemic Control (HbA1c) [ Time Frame: HbA1c at 12 months post intervention follow-up ]

Locations (1)

FacilityCityStateZIPSite coordinators
State University of New York at BuffaloBuffaloNew York14203-

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Type 2 diabetes
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EndocrinologyMetabolic healthWeight loss
By research site
State University of New York at Buffalo· Buffalo, NY

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