Diabetes medication and wellness coaching for adults who have recently experienced homelessness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.