Type 2 DiabetesD-HOMES R01NCT07091487
Effectiveness of the Diabetes Homeless Medication Support (D-HOMES) Program on Diabetes Management
A study testing Diabetes Homeless Medication Support in people with Type 2 Diabetes, run by Katherine Vickery at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Diabetes Homeless Medication Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2025to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55404
Katherine D Vickery, MD, MSc, 612-873-6852, katherine.vickery@hcmed.org
Katherine D Vickery, MD, MSc
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?
Read more
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Diabetes Homeless Medication Support, Enhanced Usual Care/ Education
- Keywords
- Type 2 Diabetes, Homelessness, Behavioral Activation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Homeless Medication SupportBehavioural
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/ EducationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care/Education Session | Active comparator | Brief one-on-one diabetes education session provided by a diabetes wellness coach. Receives: Behavioral: Enhanced Usual Care/ Education |
| Diabetes Homeless Medication Support (D-HOMES) | Experimental | 10 one-on-one behavioral treatments by a diabetes wellness coach. Receives: Behavioral: Diabetes Homeless Medication Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Baseline 1 to Month 3 assessment
Secondary outcomes (14)
HbA1c at 6 months
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, at 6 months
Measured: Baseline 1 to 6-month assessment
HbA1c at 12 months
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, at 12 months
Measured: Baseline 1 to 12-month assessment
Diabetes self-care and medication adherence (DSMQ) - 3 months
The Diabetes Self-Management Questionnaire (DSMQ) is a brief, comprehensive 16-item self-report instrument designed to assess four subscales -Glucose Management, Dietary Control, Physical Activity, and Health-Care Use - as well as a global measure called the Sum Scale. This tool uses a likert scale of 0-3.
Measured: Baseline 2 to 3-month assessment
Diabetes self-care and medication adherence (DSMQ) - 6 months
The Diabetes Self-Management Questionnaire (DSMQ) is a brief, comprehensive 16-item self-report instrument designed to assess four subscales -Glucose Management, Dietary Control, Physical Activity, and Health-Care Use - as well as a global measure called the Sum Scale. This tool uses a likert scale of 0-3.
Measured: Baseline 2 to 6-month assessment
Difficulties with diabetes management (PAID-5) at 3 months
The PAID-5 is a short, five-item questionnaire used to assess diabetes-related emotional distress. Each item is scored on a scale of 0 to 4. The total score ranges from 0 to 20, with scores of 8 or above indicating diabetes-related distress.
Measured: Baseline 2 to 3-month assessment
Difficulties with diabetes management (PAID-5) at 6 months
The PAID-5 is a short, five-item questionnaire used to assess diabetes-related emotional distress. Each item is scored on a scale of 0 to 4. The total score ranges from 0 to 20, with scores of 8 or above indicating diabetes-related distress.
Measured: Baseline 2 to 6-month assessment
MHI-5 at 3 months
The Mental Health Inventory - Five Item (MHI-5) includes 5 questions about mental health over the past month. Responses are on a likert scale ranging from 1 = all the time to 6 = none of the time. Raw scores range from a minimum of 5 to a maximum of 30, where higher scores indicate better mental health.
Measured: Baseline 2 through 3-month assessment
MHI-5 at 6 months
The Mental Health Inventory - Five Item (MHI-5) includes 5 questions about mental health over the past month. Responses are on a likert scale ranging from 1 = all the time to 6 = none of the time. Raw scores range from a minimum of 5 to a maximum of 30, where higher scores indicate better mental health.
Measured: Baseline 2 through 6-month assessment
Euro-QoL-5 at 3 months
The EuroQuol-5D-5L has 6 questions. 5 of these questions address mobility, self care, usual activities, pain/discomfort, and anxiety/depression. These 5 questions are answered on a likert scale of 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, 5=unable to/extreme problems. The 6th question is a 0-100 scale of overall health. Data is presented as a health state or a 5-digit code representing the 1-5 responses of the 5 questions.
Measured: Baseline 2 to 3-month assessment
Euro-QoL-5 at 6 months
The EuroQuol-5D-5L has 6 questions. 5 of these questions address mobility, self care, usual activities, pain/discomfort, and anxiety/depression. These 5 questions are answered on a likert scale of 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, 5=unable to/extreme problems. The 6th question is a 0-100 scale of overall health. Data is presented as a health state or a 5-digit code representing the 1-5 responses of the 5 questions.
Measured: Baseline 2 to 6-month assessment
Blood Pressure at 3 months
Recorded in systolic/diastolic mmHg
Measured: Baseline 1 to 3-month assessment
Blood Pressure at 6 months
Recorded in systolic/diastolic mmHg
Measured: Baseline 1 to 6-month assessment
Body Mass Index (BMI) at 3 months
Measured as BMI = weight (kg) / height (m)^2
Measured: Baseline 1 to 3-month assessment
Body Mass Index (BMI) at 6 months
Measured as BMI = weight (kg) / height (m)^2
Measured: Baseline 1 to 6-month assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start25 Jun 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Katherine Vickery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Katherine Vickery, Hennepin Healthcare Research Institute
- Investigators
- Katherine D Vickery, MD, MSc, Principal investigator, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091487
- Sponsor's protocol ID
- IRB-FY2024-849
- Other IDs
- R01DK139152
- Acronym
- D-HOMES R01
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Diabetes Homeless Medication Support (D-HOMES) Program on Diabetes Management
- ClinicalTrials.gov ID
- NCT07091487
- Acronym / sponsor ID
- D-HOMES R01 / IRB-FY2024-849
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Homelessness, Behavioral Activation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Katherine VickeryUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care/Education Session | Active comparator | Behavioral: Enhanced Usual Care/ EducationBrief one-on-one diabetes education session provided by a diabetes wellness coach. |
| Diabetes Homeless Medication Support (D-HOMES) | Experimental | Behavioral: Diabetes Homeless Medication Support10 one-on-one behavioral treatments by a diabetes wellness coach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 yrs. or older
- English or Spanish-speaking
- Recent homelessness by HUD and HHS definitions
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes Homeless Medication SupportThere 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. | Behavioural | Diabetes Homeless Medication Support (D-HOMES) |
| Enhanced Usual Care/ EducationTrained 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). | Behavioural | Enhanced Usual Care/Education Session |
Primary outcome
Change in HbA1c at 3 months
Time frame: From Baseline 1 to Month 3 assessment
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
14 secondary outcomes
HbA1c at 6 months
Time frame: Baseline 1 to 6-month assessment
HbA1c at 12 months
Time frame: Baseline 1 to 12-month assessment
Diabetes self-care and medication adherence (DSMQ) - 3 months
Time frame: Baseline 2 to 3-month assessment
Diabetes self-care and medication adherence (DSMQ) - 6 months
Time frame: Baseline 2 to 6-month assessment
Difficulties with diabetes management (PAID-5) at 3 months
Time frame: Baseline 2 to 3-month assessment
Difficulties with diabetes management (PAID-5) at 6 months
Time frame: Baseline 2 to 6-month assessment
MHI-5 at 3 months
Time frame: Baseline 2 through 3-month assessment
MHI-5 at 6 months
Time frame: Baseline 2 through 6-month assessment
Euro-QoL-5 at 3 months
Time frame: Baseline 2 to 3-month assessment
Euro-QoL-5 at 6 months
Time frame: Baseline 2 to 6-month assessment
Blood Pressure at 3 months
Time frame: Baseline 1 to 3-month assessment
Blood Pressure at 6 months
Time frame: Baseline 1 to 6-month assessment
Body Mass Index (BMI) at 3 months
Time frame: Baseline 1 to 3-month assessment
Body Mass Index (BMI) at 6 months
Time frame: Baseline 1 to 6-month assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine D Vickery, MD, MSc principal investigator
Hennepin Healthcare Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Homeless Medication Support in people with Type 2 Diabetes, run by Katherine Vickery at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine D Vickery, MD, MSc (6128736852, katherine.vickery@hcmed.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c at 3 months (time frame: From Baseline 1 to Month 3 assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.