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

March 11, 2024 updated by: Egede, Leonard E, Medical College of Wisconsin

HOME DM-BAT: 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 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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. 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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age >=65 years of age;
  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:

  1. Mental confusion at screening assessment suggesting significant dementia;
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
Behavioral: Supportive Therapy (Control)
Description: 8-weekly sessions of in-home, supportive therapy and monthly booster sessions from months 3-12 via telephone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control (HbA1c)
Time Frame: Change in baseline 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.
Change in baseline HbA1c at 12 months post intervention follow-up
Systolic and Diastolic Blood Pressure
Time Frame: Change in baseline blood pressure at 12 months post intervention follow-up
Blood pressure readings will be obtained using automated BP monitors (OMRON IntelliSenseTM HEM-907XL). The device will be programmed to take 3 readings at 2-minute intervals, and give an average of the 3 BP readings.
Change in baseline blood pressure at 12 months post intervention follow-up
LDL-Cholesterol
Time Frame: Change in baseline cholesterol at 12 months post intervention follow-up
About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for LDL-Cholesterol.
Change in baseline cholesterol at 12 months post intervention follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life as measured by SF-12
Time Frame: Change in baseline quality of life measure at 12 months post intervention follow-up
The SF-12 (Ware 1996) is a valid and reliable instrument to measure functional status and reproduces 90% of the variance in PCS-36 and MCS-36 scores.
Change in baseline quality of life measure at 12 months post intervention follow-up
Self-Care Behaviors
Time Frame: Change in baseline self-care behaviors at 12 months post intervention follow-up
Behavioral skills will be assessed with the Summary of Diabetes Self-Care Activities (SDSCA) scale (Toobert 2000), a brief, validated questionnaire of diabetes self-care. Medication Adherence will be measured with the 6-item validated self-report Brooks Medication Adherence Scale (BMAS) (Brooks 1994). Each of 6 items measures a specific medication-taking behavior.
Change in baseline self-care behaviors at 12 months post intervention follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality Adjusted Life Years as measured by EQ-5D
Time Frame: Change in baseline quality of life measure at 12 months post intervention follow-up
The EQ-5D is a validated measure to assess health status developed by the EuroQol group, an international team of researchers. This scale assesses health status across 5 dimensions using 26 items (Herdman 2011).
Change in baseline quality of life measure at 12 months post intervention follow-up
Resource Utilization and Cost
Time Frame: Change in baseline baseline resource utilization and cost at 12 months post intervention follow-up
Previously validated questions on resource utilization will be administered. The questionnaires capture information on hospitalizations, physician/professional visits, and medications.
Change in baseline baseline resource utilization and cost at 12 months post intervention follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Investigators

  • Principal Investigator: Leonard E Egede, MD, MS, Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2020

Primary Completion (Actual)

January 31, 2024

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

November 26, 2019

First Submitted That Met QC Criteria

December 16, 2019

First Posted (Actual)

December 18, 2019

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01DK118038-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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