NCT07091487Recruiting
Effectiveness of the Diabetes Homeless Medication Support (D-HOMES) Program on Diabetes Management
Source: ClinicalTrials.gov · Last updated 29 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 256 (estimated)
- First submitted
- 21 Jul 2025
- Start date
- 25 Jun 2025
- Primary completion date
- 30 Dec 2028
- Lead sponsor
- Katherine Vickery
- Diseases
- Type 2 diabetes
- NCT number
- NCT07091487
What you commit to
- Study type: Interventional
- Planned participants: 256
- From 25 Jun 2025 to the primary completion date, 30 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Inability to provide informed consent (e.g., presence of a legal guardian, prisoners)
- Active psychosis or intoxication precluding ability to give informed consent
- Pregnant or lactating people at initial enrollment, determined by specific screening questions.
Who the study is looking for
- Age 18 yrs. or older
- English or Spanish-speaking
- 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)
- Self-reported diagnosis of type 2 diabetes with A1c \>7.5%, later verified in medical record and study lab. test
- Plan to stay in local area or be reachable by phone for the next 12 months
- Willingness to work on medication adherence and diabetes self-care
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hennepin Healthcare Research Institute Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.