Home-based Diabetes-Modified Behavioral Activation Treatment for Low Income Seniors With T2DM
NCT ID: NCT04203147
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
200 participants
INTERVENTIONAL
2020-01-03
2025-12-31
Brief Summary
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The aims of this randomized controlled efficacy trial are:
Aim 1: To test the efficacy of Home DM-BAT on clinical outcomes (hemoglobin A1c, blood pressure, and LDL-Cholesterol).
Hypothesis 1: Low income, minority seniors with poorly controlled T2DM randomized to Home DM-BAT will have significantly greater improvements in clinical outcomes (hemoglobin A1c, blood pressure, and LDL-Cholesterol) at 12 months of follow-up compared to the control group (in-home, telephone-delivered supportive therapy - ST).
Aim 2: To test the efficacy of Home DM-BAT on behavioral outcomes (home blood glucose monitoring, diet, exercise and medication adherence) and quality of life.
Hypothesis 2: Low income, minority seniors with poorly controlled T2DM randomized to Home DM-BAT will have significantly greater improvements in behavioral outcomes (home blood glucose monitoring, diet, exercise and medication adherence) and quality of life (physical and mental health components of SF-12) at 12 months of follow-up compared to the control group.
Aim 3: To determine the cost-effectiveness of Home DM-BAT intervention for diabetes.
Hypothesis 3: Home DM-BAT will be more cost-effective in improving hemoglobin A1c levels at 12 months of follow-up, compared to the control group, as measured by differences in program costs, resource utilization, and hemoglobin A1c levels.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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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.
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.
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.
Supportive Therapy (Control)
Description: 8-weekly sessions of in-home, supportive therapy and monthly booster sessions from months 3-12 via telephone.
Interventions
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Supportive Therapy (Control)
Description: 8-weekly sessions of in-home, supportive therapy and monthly booster sessions from months 3-12 via telephone.
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.
Eligibility Criteria
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Inclusion Criteria
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 community dwelling elderly adults in the greater Milwaukee area and surrounding counties that have high African American/Hispanic populations.
Exclusion Criteria
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.
65 Years
ALL
No
Sponsors
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State University of New York at Buffalo
OTHER
Responsible Party
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Leonard Ehianu Egede
Professor & Chair, Department of Medicine
Principal Investigators
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Leonard E Egede, MD, MS
Role: PRINCIPAL_INVESTIGATOR
State University of New York at Buffalo
Locations
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State University of New York at Buffalo
Buffalo, New York, United States
Countries
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References
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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.
Other Identifiers
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