Diabetes Homeless Medication Support for Type 2 Diabetes

(D-HOMES R01 Trial)

Overseen By Katherine D Vickery, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Katherine Vickery

Disqualifiers: Active psychosis, Intoxication, Pregnancy, others

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

Compensation: Varies

Number of Visits: 15

Duration: 10 weeks

256 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a wellness coaching model can improve health outcomes for people with type 2 diabetes who have recently experienced homelessness. Researchers will compare a one-time diabetes education session to 10 weeks of personalized wellness coaching to determine which approach better manages blood sugar levels, blood pressure, and overall well-being. Individuals with type 2 diabetes and a blood sugar level (HbA1c) above 7.5, who have recently faced housing instability, such as staying in shelters or worrying about paying rent, may be suitable candidates. Participants will either attend a single education session or engage in weekly coaching sessions to help manage their diabetes.

As an unphased trial, this study offers a unique opportunity to explore innovative wellness strategies for managing diabetes and improving overall health.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It focuses on wellness coaching and education for diabetes management, so it's likely you can continue your current medications, but you should confirm with the trial coordinators.

What prior data suggests that the D-HOMES wellness coaching model is safe?

A previous study tested the Diabetes Homeless Medication Support (D-HOMES) program to evaluate its effectiveness in managing Type 2 diabetes. The study showed that the wellness coaching model effectively helped participants take their medication regularly and improved their mental well-being. Participants in the D-HOMES program reported no serious side effects, suggesting the program is manageable.

The D-HOMES program includes one-on-one sessions with a diabetes wellness coach, providing personalized support. This method has been used in similar situations without major safety issues, indicating it is generally safe for participants. Although direct safety data is limited, the absence of reported problems in earlier studies suggests that this support program is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Diabetes Homeless Medication Support (D-HOMES) approach because it offers a personalized touch that current standard treatments, like medication and lifestyle changes, might lack for the homeless population with Type 2 diabetes. Unlike standard care, which often involves general education and medication, D-HOMES provides ten one-on-one behavioral sessions with a diabetes wellness coach. This tailored support is designed to address the unique challenges faced by homeless individuals, potentially leading to better management of their condition. By focusing on personalized behavioral support, D-HOMES aims to improve adherence to treatment and overall health outcomes in a group that often struggles with traditional healthcare access.

What evidence suggests that the D-HOMES wellness coaching model is effective for Type 2 diabetes in individuals who have recently experienced homelessness?

Research shows that the Diabetes Homeless Medication Support (D-HOMES) program can assist people with Type 2 diabetes who have experienced homelessness. Early results suggest that participants in D-HOMES had better blood pressure control, improved quality of life, and felt less stressed about managing their diabetes. They also adhered to their diabetes medication regimen more consistently. In this trial, some participants will receive the D-HOMES program, which includes 10 one-on-one behavioral treatments with a diabetes wellness coach. Others will receive Enhanced Usual Care, consisting of a brief one-on-one diabetes education session. The wellness coaching in D-HOMES aims to help people manage their diabetes more effectively, which is especially beneficial for those facing challenges like homelessness that complicate diabetes management. ^{1 2 3 4 6}

Who Is on the Research Team?

Katherine D Vickery, MD, MSc

Principal Investigator

Hennepin Healthcare Research Institute

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking adults with Type 2 diabetes who have an HbA1c level at or above 7.5 and have recently experienced homelessness. The study aims to see if a wellness coaching program can improve their diabetes management compared to just one education session.

Inclusion Criteria

I am 18 years old or older.

Recent homelessness by HUD and HHS definitions: Any housing instability in the last 12 mo. (includes supported housing or worry about paying rent), Significant housing instability in the last 24 mos. (includes any stay in shelter, outside, or places not meant for human habitation)

Willingness to work on medication adherence and diabetes self-care

Exclusion Criteria

Inability to provide informed consent (e.g., presence of a legal guardian, prisoners)

Active psychosis or intoxication precluding ability to give informed consent

I am not pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete two baseline assessments to establish initial health metrics

1-2 weeks

2 visits (in-person)

Treatment

Participants receive either a one-time education session or 10 weeks of wellness coaching

10 weeks

10 visits (in-person or virtual)

Follow-up

Participants are monitored for changes in HbA1c, blood pressure, quality of life, and other health metrics at 3, 6, and 12 months

12 months

3 visits (in-person) at months 3, 6, and 12

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes Homeless Medication Support

Trial Overview Researchers are testing the D-HOMES program, which includes 10 weeks of wellness coaching, against a single educational session about diabetes. They're looking at how each approach affects participants' blood sugar control (HbA1c levels) and other health outcomes over a year.

How Is the Trial Designed?

Group I: Diabetes Homeless Medication Support (D-HOMES) Experimental Treatment 1 Intervention

10 one-on-one behavioral treatments by a diabetes wellness coach.

Group II: Enhanced Usual Care/Education Session Active Control 1 Intervention

Brief one-on-one diabetes education session provided by a diabetes wellness coach.

Who Is Running the Clinical Trial?

Katherine Vickery

Lead Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07091487

Effectiveness of the Diabetes Homeless Medication ... Do D-HOMES participants have improvements in blood pressure control, quality of life, self-reported psychological wellness, diabetes distress, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10983143/

The Diabetes Homeless Medication Support (D-HOMES ... People experiencing homelessness have 3-6x higher diabetes mortality than their stably housed peers despite similar prevalence. Evidence supports health coach ...

3. taggs.hhs.gov taggs.hhs.gov/Detail/AwardDetail?arg_AwardNum=R01DK139152&arg_ProgOfficeCode=119

Award Information | HHS TAGGS Effectiveness of the Diabetes Homeless Medication Support (D-HOMES) program on diabetes management. Award Number: R01DK139152 ...

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1329138/full

Pilot trial results of D-HOMES: a behavioral-activation ... A one-on-one, 3 month, coaching intervention to improve medication adherence and psychological wellness for DH.

5. patlynk.com patlynk.com/trial/NCT05258630

Diabetes Homeless Medication Support (D-Homes) The study team will compare ARMS-D scores from baseline to 16 weeks and baseline to 30 weeks.

6. diabetesjournals.org diabetesjournals.org/care/article/46/8/1469/151480/The-Association-of-Homelessness-With-Rates-of

The Association of Homelessness With Rates of Diabetes ... The rate of macrovascular complications was higher for people with a history of homelessness compared with nonhomeless control subjects.