Effectiveness of the Diabetes Homeless Medication Support (D-HOMES) Program on Diabetes Management
D-HOMES R01
2 other identifiers
interventional
256
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Jun 2025
Longer than P75 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 25, 2025
CompletedFirst Submitted
Initial submission to the registry
July 21, 2025
CompletedFirst Posted
Study publicly available on registry
July 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2029
July 29, 2025
July 1, 2025
3.5 years
July 21, 2025
July 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c at 3 months
Measure effectiveness of D-HOMES (10 BA coach sessions over 3 mos.) vs. enhanced usual care (\[EUC\], a single brief diabetes educational session and referrals) on glycemic control, measured by HbA1c, among people who have recently experienced homelessness
From Baseline 1 to Month 3 assessment
Secondary Outcomes (14)
HbA1c at 6 months
Baseline 1 to 6-month assessment
HbA1c at 12 months
Baseline 1 to 12-month assessment
Diabetes self-care and medication adherence (DSMQ) - 3 months
Baseline 2 to 3-month assessment
Diabetes self-care and medication adherence (DSMQ) - 6 months
Baseline 2 to 6-month assessment
Difficulties with diabetes management (PAID-5) at 3 months
Baseline 2 to 3-month assessment
- +9 more secondary outcomes
Study Arms (2)
Enhanced Usual Care/Education Session
ACTIVE COMPARATORBrief one-on-one diabetes education session provided by a diabetes wellness coach.
Diabetes Homeless Medication Support (D-HOMES)
EXPERIMENTAL10 one-on-one behavioral treatments by a diabetes wellness coach.
Interventions
There will be 10 one-on-one sessions offered within 12 weeks to participants. Sessions will last approximately 30 minutes. During sessions a diabetes wellness coach will use behavioral activation and motivational interviewing to get to know participants and set goals to improve diabetes care. The coach will encourage a focus on medication adherence behaviors and psychologiccal wellness to the extent that participants are willing. The coach will also help with resource and care coordination. The coach will also provide a tailored tool matched to the patient's needs/goals and tailored diabetes education as needed.
Trained diabetes wellness coaches will provide approximately 15 minutes of instruction about the basic concepts of diabetes. They will use handouts aligned with American Diabetes Association guidelines. They will use the ask-offer-ask method to review these with participants and answer basic questions. Handouts will cover (1) general diabetes knowledge, (2) healthy eating with diabetes, (3) physical activity with diabetes. The coach will also provide a general tool to support medication adherence (e.g. pillbox).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55404, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine D Vickery, MD, MSc
Hennepin Healthcare Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Primary Investigator
Study Record Dates
First Submitted
July 21, 2025
First Posted
July 29, 2025
Study Start
June 25, 2025
Primary Completion (Estimated)
December 30, 2028
Study Completion (Estimated)
September 30, 2029
Last Updated
July 29, 2025
Record last verified: 2025-07