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Effectiveness of the Diabetes Homeless Medication Support (D-HOMES) Program on Diabetes Management
NCT07091487 · Hennepin Healthcare Research Institute
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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.
Eligibility 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.
Study design
Enrollment target: 256 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-06-25
Estimated completion: 2029-09-30
Last updated: 2025-07-29
Interventions
Behavioral: Diabetes Homeless Medication SupportBehavioral: Enhanced Usual Care/ Education
Primary outcomes
- • Change in HbA1c at 3 months (From Baseline 1 to Month 3 assessment)
Sponsor
Katherine Vickery · other
With: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contacts & investigators
ContactKatherine D Vickery, MD, MSc · contact · katherine.vickery@hcmed.org · 6128736852
InvestigatorKatherine D Vickery, MD, MSc · principal_investigator, Hennepin Healthcare Research Institute
All locations (1)
Hennepin Healthcare Research InstituteRecruiting
Minneapolis, Minnesota, United States