Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04203147
Recruitment Status : Suspended (Due to COVID-19, a partial suspension of human subjects research was put into effect for research involving direct contact with human subjects.)
First Posted : December 18, 2019
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Egede, Leonard E, Medical College of Wisconsin

Brief Summary:

The objective of this protocol is to evaluate the efficacy and cost-effectiveness of 8 sessions of in-home, group-based, 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, living in independent senior housing in Milwaukee using a cluster-randomized design.

The aims of this cluster-randomized 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, group-based 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.

Exploratory Analyses: Investigators will evaluate the impact of key social determinants of health (e.g. food insecurity, housing insecurity, competing needs, stress/coping etc.) on clinical, behavioral and quality of life outcomes and their roles as potential mediators or moderators of treatment efficacy.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Supportive Therapy (Control) Behavioral: Home DM-BAT Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: HOME DM-BAT: Home-based Diabetes-Modified Behavioral Activation Treatment for Low Income Seniors With T2DM
Actual Study Start Date : January 3, 2020
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Home DM-BAT Intervention
A trained nurse educator will deliver the manualized Home DM-BAT intervention in a group setting. Subjects will receive 8-weekly sessions of behavioral activation and monthly booster sessions from months 3-12.
Behavioral: Home DM-BAT
Description: 8?weekly sessions of in-home, group-based, culturally-modified, manualized diabetes-modified, behavioral activation treatment (Home DM-BAT) and monthly booster sessions from months 3-12.

Active Comparator: Control Group (GHE+ST)
Patients randomized to the control group will receive group-based in-home 8-weekly sessions of combined general health education (GHE) and supportive therapy (ST) and monthly booster sessions from months 3-12.
Behavioral: Supportive Therapy (Control)
Description: 8-weekly sessions of in-home, group-based supportive therapy and monthly booster sessions from months 3-12.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Glycemic control (HbA1c) [ Time Frame: Change in baseline HbA1c at 12 months post intervention follow-up ]
    Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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).

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

5) Able to communicate in English or Spanish; and 6) Resident of independent or subsidized senior housing facility in Milwaukee County.

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 based on medical history and comorbidity screen used in prior studies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04203147


Locations
Layout table for location information
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Layout table for investigator information
Principal Investigator: Leonard E Egede, MD, MS Medical College of Wisconsin
Layout table for additonal information
Responsible Party: Egede, Leonard E, Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT04203147    
Other Study ID Numbers: 1R01DK118038-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 18, 2019    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases