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Home-Based Behavioral Therapy for Type 2 Diabetes (HOME DM-BAT Trial)
N/A
Waitlist Available
Led By Leonard E Egede, MD, MS
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in baseline quality of life measure at 12 months post intervention follow-up
Awards & highlights
HOME DM-BAT Trial Summary
This trial will test the efficacy of a diabetes-modified behavioral activation treatment delivered by trained diabetes nurse educators to low income, ethnic minority seniors with poorly controlled T2DM. The study will also compare the cost-effectiveness of the intervention.
Who is the study for?
This trial is for low-income seniors aged 65 or older with poorly controlled Type 2 Diabetes (T2DM), specifically those who are Black/African American or Hispanic, living in Milwaukee area senior housing or communities. Participants must have an HbA1c level of at least 8% and be able to communicate in English or Spanish. Those with active psychosis, severe mental disorders, substance abuse issues, participation in other diabetes studies, significant dementia, or a life expectancy under one year cannot join.Check my eligibility
What is being tested?
The study tests Home DM-BAT—a culturally-tailored home and phone-based intervention by nurse educators—against supportive therapy control. It aims to improve clinical outcomes like blood sugar levels (hemoglobin A1c), blood pressure, cholesterol; behavioral aspects such as glucose monitoring, dieting habits; exercise routines; medication adherence; and overall quality of life over a period of 12 months.See study design
What are the potential side effects?
Since the interventions involve educational support rather than medications there may not be direct side effects like drugs cause. However participants might experience stress due to lifestyle changes recommended during the treatment.
HOME DM-BAT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in baseline self-care behaviors at 12 months post intervention follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in baseline self-care behaviors at 12 months post intervention follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glycemic control (HbA1c)
LDL-Cholesterol
Systolic and Diastolic Blood Pressure
Secondary outcome measures
Quality of Life as measured by SF-12
Self-Care Behaviors
Other outcome measures
Quality Adjusted Life Years as measured by EQ-5D
Resource Utilization and Cost
HOME DM-BAT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Home DM-BAT InterventionExperimental Treatment1 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.
Group II: Control Group (GHE+ST)Active Control1 Intervention
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.
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,401 Total Patients Enrolled
Leonard E Egede, MD, MSPrincipal InvestigatorMedical College of Wisconsin
6 Previous Clinical Trials
1,109 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with type 2 diabetes and have an HbA1c level of 8% or higher.You currently have severe mental health issues.Your doctor thinks you may have less than a year to live.You have severe memory problems or confusion.You are 65 years old or older.You live in a senior housing facility or community in the Milwaukee area with a high number of African American/Hispanic residents.You have been involved in other studies related to diabetes.You define yourself as Black/African American or Hispanic.You have a problem with drinking too much alcohol or using drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group (GHE+ST)
- Group 2: Home DM-BAT Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the scope of participants in this trial?
"Affirmative. The information provided on clinicaltrials.gov suggests that this medical study, which was first advertised on March 1st 2020, currently requires enrolment of 200 participants from a single site."
Answered by AI
Is this trial still accepting new volunteers?
"Clinicaltrials.gov reports that this research is still in need of volunteers, with the original post date being marked as March 1st 2020 and the most recent edition occuring on July 23rd 2022."
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