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

Phase

N/A

Condition

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Diabetes Prevention

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 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.

Eligibility Criteria

Inclusion

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 communitydwelling elderly adults in the greater Milwaukee area and surrounding counties thathave high African American/Hispanic populations.

Exclusion

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.

Study Design

Supportive Therapy (Control)

January 03, 2020

December 31, 2025

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. Study assessments will be performed by blinded research assistants at baseline, 3-, 6-, 9-, and 12-months of follow-up. 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, New York 14203
United States
Site Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Site Not Available

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