Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07091487

Effectiveness of the Diabetes Homeless Medication Support (D-HOMES) Program on Diabetes Management

Led by Katherine Vickery · Updated on 2025-07-29

256

Participants Needed

1

Research Sites

222 weeks

Total Duration

On this page

Sponsors

K

Katherine Vickery

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if the Diabetes Homelessness Medication Support (D-HOMES) wellness coaching model is effective for adults who speak English or Spanish, have Type 2 diabetes with an HbA1c at or above 7.5, and have recently experienced homelessness. Researchers will compare a one-time education session about diabetes to 10 wellness coaching sessions to see if there are differences between the groups' health outcomes. The main questions it aims to answer are: * Do D-HOMES participants have greater reductions in HbA1c at 3 months than participants who received education? * Do D-HOMES participants have greater reductions in HbA1c at 6 and 12 months compared to those who received education? * Do D-HOMES participants have improvements in blood pressure control, quality of life, self-reported psychological wellness, diabetes distress, and diabetes medication adherence and self-management at 3, 6, and 12 months? * What factors must be considered to make D-HOMES scalable? Participants will: * complete 5 assessments including two baseline assessments and follow-ups at months 3,6, and 12 * participate in a one-time education session or 10 weeks of wellness coaching.

CONDITIONS

Official Title

Effectiveness of the Diabetes Homeless Medication Support (D-HOMES) Program on Diabetes Management

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • English or Spanish speaking
  • Recent homelessness or housing instability as defined by HUD and HHS
  • Self-reported diagnosis of Type 2 diabetes with HbA1c greater than 7.5%, verified by medical record or study lab test
  • Plan to stay in local area or be reachable by phone for 12 months
  • Willingness to work on medication adherence and diabetes self-care
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent (such as having a legal guardian or being a prisoner)
  • Active psychosis or intoxication preventing informed consent
  • Pregnant or lactating at enrollment, determined by screening

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Trial Site Locations

Total: 1 location

1

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, United States, 55404

Actively Recruiting

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Research Team

K

Katherine D Vickery, MD, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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