Diabetes medication and wellness coaching for adults who have recently experienced homelessness
Effectiveness of the Diabetes Homeless Medication Support (D-HOMES) Program on Diabetes Management
This program tests whether 10 wellness coaching sessions (D-HOMES) help English- or Spanish-speaking adults with type 2 diabetes and A1c ≥7.5% who have recently experienced homelessness do better than a one-time education session.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hennepin Healthcare Research Institute Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT07091487 on ClinicalTrials.gov |
What this trial studies
Adults who speak English or Spanish, have type 2 diabetes with A1c ≥7.5%, and have recently experienced homelessness are enrolled and randomized to either a single enhanced education visit or the D-HOMES program consisting of 10 wellness coaching sessions focused on medication adherence and self-management. The study measures change in HbA1c at 3 months as the primary outcome and follows participants at 6 and 12 months for durable effects. Secondary outcomes include blood pressure control, quality of life, psychological wellness, diabetes distress, and self-reported medication adherence. The intervention is delivered locally through Hennepin Healthcare with outcomes verified by medical records and study lab testing.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) who speak English or Spanish, have type 2 diabetes with A1c ≥7.5%, have recently experienced housing instability or homelessness, plan to remain locally or be reachable for 12 months, and are willing to work on medication adherence and self-care.
Not a fit: People with A1c below 7.5%, those not recently homeless, individuals unable to give informed consent, those with active psychosis or intoxication preventing participation, or people who are pregnant or lactating at enrollment may not benefit from this program.
Why it matters
Potential benefit: If successful, the program could improve blood sugar control, medication adherence, and overall quality of life for people with diabetes who have experienced homelessness.
How similar studies have performed: Behavioral coaching and medication-adherence interventions have improved diabetes outcomes in other populations, but programs specifically tailored to people experiencing homelessness are relatively limited and less well tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 yrs. or older 2. English or Spanish-speaking 3. Recent homelessness by HUD and HHS definitions 1. Any housing instability in the last 12 mo. (includes supported housing or worry about paying rent) 2. Significant housing instability in the last 24 mos. (includes any stay in shelter, outside, or places not meant for human habitation) 4. Self-reported diagnosis of type 2 diabetes with A1c \>7.5%, later verified in medical record and study lab. test 5. Plan to stay in local area or be reachable by phone for the next 12 months 6. Willingness to work on medication adherence and diabetes self-care Exclusion Criteria: 1. Inability to provide informed consent (e.g., presence of a legal guardian, prisoners) 2. Active psychosis or intoxication precluding ability to give informed consent 3. Pregnant or lactating people at initial enrollment, determined by specific screening questions.
Where this trial is running
Minneapolis, Minnesota
- Hennepin Healthcare Research Institute — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Katherine D Vickery, MD, MSc — Hennepin Healthcare Research Institute
- Study coordinator: Katherine D Vickery, MD, MSc
- Email: katherine.vickery@hcmed.org
- Phone: 6128736852
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.