Effectiveness of the Diabetes Homeless Medication Support (D-HOMES) Program on Diabetes Management
NCT ID: NCT07091487
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
256 participants
INTERVENTIONAL
2025-06-25
2029-09-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Enhanced Usual Care/Education Session
Brief one-on-one diabetes education session provided by a diabetes wellness coach.
Enhanced Usual Care/ Education
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).
Diabetes Homeless Medication Support (D-HOMES)
10 one-on-one behavioral treatments by a diabetes wellness coach.
Diabetes Homeless Medication Support
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.
Interventions
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Diabetes Homeless Medication Support
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.
Enhanced Usual Care/ Education
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
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Inclusion Criteria
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
2. Active psychosis or intoxication precluding ability to give informed consent
3. Pregnant or lactating people at initial enrollment, determined by specific screening questions.
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Katherine Vickery
OTHER
Responsible Party
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Katherine Vickery
Primary Investigator
Principal Investigators
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Katherine D Vickery, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Hennepin Healthcare Research Institute
Locations
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Hennepin Healthcare Research Institute
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-FY2024-849
Identifier Type: -
Identifier Source: org_study_id
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