Home-Based Behavioral Therapy for Type 2 Diabetes

(HOME DM-BAT Trial)

Not currently recruiting at 1 trial location

Overseen By Elise A Mosley-Johnson, MPH

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Dementia, Substance abuse, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new home-based therapy for people with type 2 diabetes (T2DM) to determine its impact on health outcomes such as blood sugar levels, blood pressure, and cholesterol. Participants will engage in therapy sessions over the phone, focusing on lifestyle changes and medication habits. The trial aims to assess whether this method is more effective and affordable than standard support. It seeks seniors who identify as Black or Hispanic, have T2DM with high blood sugar levels, and reside in senior housing in the Milwaukee area. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to more accessible diabetes care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on behavioral therapy and medication adherence, so it's likely you can continue your current medications, but you should confirm with the trial organizers.

What prior data suggests that this protocol is safe for participants?

Research has shown that the Home-based Diabetes-Modified Behavioral Activation Treatment (Home DM-BAT) is generally easy for people to handle. This treatment helps manage diabetes by encouraging lifestyle changes, such as eating healthier and exercising more. Studies have not reported any serious side effects from this therapy.

The treatment includes support from trained diabetes nurse educators who assist participants in managing their diabetes through regular sessions that offer practical and supportive advice. Since this study does not involve testing a new drug, it is expected to be safe for participants.

In summary, Home DM-BAT appears to be a safe option based on current research. It focuses on supporting lifestyle changes, which are generally considered low-risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Type 2 Diabetes, which often involve medication and dietary changes, the Home-Based Diabetes-Modified Behavioral Activation Treatment (DM-BAT) focuses on modifying behavior through a structured program. This approach is delivered directly in the home by a trained nurse, making it more accessible and personalized. Researchers are excited about this method because it empowers patients to manage their diabetes by addressing lifestyle and mental health factors, potentially leading to long-term improvements in both physical and mental well-being.

What evidence suggests that this protocol is effective for Type 2 Diabetes?

Research has shown that a home-based diabetes treatment called Home DM-BAT, which participants in this trial may receive, can help people with type 2 diabetes. Studies have found that this approach can lower blood sugar levels, blood pressure, and LDL cholesterol (the "bad" cholesterol). It also helps patients improve their diet, exercise habits, and medication routines. Additionally, Home DM-BAT can enhance both physical and mental quality of life. This treatment might also offer a more affordable way to manage diabetes compared to other methods. ^{3 4 6 7 8}

Who Is on the Research Team?

Leonard Egede, MD

Principal Investigator

State University of New York at Buffalo

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able to communicate in English or Spanish

You have been diagnosed with type 2 diabetes and have an HbA1c level of 8% or higher.

You are 65 years old or older.

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 weekly sessions of Home DM-BAT delivered via telephone by trained nurse educators

8 weeks

8 visits (telephone)

Booster Sessions

Participants receive monthly booster sessions from months 3 to 12

10 months

10 visits (telephone)

Follow-up

Participants are monitored for clinical and behavioral outcomes at 3, 6, 9, and 12 months post-randomization

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Home-based Diabetes-Modified Behavioral Activation Treatment
• Supportive Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Home DM-BAT Intervention Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

Cognitive Behaviour Therapy (CBT) interventions can improve self-management practices in individuals with type 2 diabetes, as highlighted by a rapid review of nine studies, primarily from developing countries.

The review emphasizes the importance of tailoring CBT interventions to the socio-economic contexts of individuals, particularly in South Africa, to enhance their effectiveness in managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the role of CBT in the self-management of type 2 diabetes: A rapid review. Visagie, E., Deacon, E., Kok, R.[2023]

Behavioral programs for adults with type 2 diabetes that include at least 11 contact hours significantly improve glycemic control, with a reduction of 0.4% or more in hemoglobin A1c (HbA1c), while programs with 10 or fewer hours show little benefit.

Participants with higher baseline HbA1c levels (7.0% or greater), those under 65 years old, and minority groups experienced greater reductions in HbA1c, indicating that these subgroups may benefit more from intensive behavioral interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Programs for Type 2 Diabetes Mellitus: A Systematic Review and Network Meta-analysis. Pillay, J., Armstrong, MJ., Butalia, S., et al.[2022]

A family-based psychological intervention significantly reduced A1C levels in patients with poorly controlled type 2 diabetes, with the intervention group showing an average A1C of 8.4% compared to 8.8% in the control group after 6 months.

The intervention was particularly effective for patients with the highest baseline A1C levels (over 9.5%), leading to notable improvements in diabetes-related beliefs, psychological well-being, diet, exercise, and family support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological family intervention for poorly controlled type 2 diabetes. Keogh, KM., Smith, SM., White, P., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12544878/

MON-533 Efficacy Of Home-based Diabetes-modified ... The primary aim of this randomized controlled trial was to test the efficacy of a home-based diabetes-modified behavioral activation treatment ( ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34749788/

HOME DM-BAT: home-based diabetes-modified behavioral ... This is a 5-year prospective, randomized clinical trial, which will test the effectiveness of a home-based diabetes-modified behavioral activation treatment ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04203147

Home-based Diabetes-Modified Behavioral Activation ... The objective of this protocol is to evaluate the efficacy and cost-effectiveness of 8 sessions of in-home, telephone-delivered, culturally-modified, ...

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05744-1

HOME DM-BAT: home-based diabetes-modified behavioral ... The primary aim of the study is to test the efficacy of HOME DM-BAT on clinical outcomes (HbA1c, blood pressure, and LDL cholesterol). The ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04203147/home-based-diabetes-modified-behavioral-activation-treatment-for-low-income-seniors-with-t2dm

Home-based Diabetes-Modified Behavioral Activation ... The objective of this protocol is to evaluate the efficacy and cost-effectiveness of 8 sessions of in-home, telephone-delivered, ...

6. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05744-1/tables/1

Table 1 Data collection measures instruments - Trials Journal Table 1 Data collection measures instruments. From: HOME DM-BAT: home-based diabetes-modified behavioral activation treatment for low-income seniors with ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8574935/

HOME DM-BAT: home-based diabetes-modified behavioral ... This is a 5-year prospective, randomized clinical trial, which will test the effectiveness of a home-based diabetes-modified behavioral activation treatment ...

8. researchgate.net researchgate.net/publication/356030076_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

(PDF) HOME DM-BAT: home-based diabetes-modified ... Discussion Results from this study will provide important insight into the effectiveness of a home-based diabetes-modified behavioral activation treatment for ...