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NCT Number: NCT07091487

Effectiveness of the Diabetes Homeless Medication Support (D-HOMES) Program on Diabetes Management

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55404, United States

Location status: Recruiting

Location contact

Katherine D Vickery, MD, MSc

CONTACT

[email protected]

612-873-6852

Katherine D Vickery, MD, MSc

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Diabetes Homeless Medication Support

Behavioral

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

Behavioral

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).

Primary outcomes

  1. 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

Secondary outcomes

  1. HbA1c at 6 months

    Time frame: Baseline 1 to 6-month assessment

    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

  2. HbA1c at 12 months

    Time frame: Baseline 1 to 12-month assessment

    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

  3. Diabetes self-care and medication adherence (DSMQ) - 3 months

    Time frame: Baseline 2 to 3-month assessment

    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.

  4. Diabetes self-care and medication adherence (DSMQ) - 6 months

    Time frame: Baseline 2 to 6-month assessment

    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.

  5. Difficulties with diabetes management (PAID-5) at 3 months

    Time frame: Baseline 2 to 3-month assessment

    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.

  6. Difficulties with diabetes management (PAID-5) at 6 months

    Time frame: Baseline 2 to 6-month assessment

    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.

  7. MHI-5 at 3 months

    Time frame: Baseline 2 through 3-month assessment

    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.

  8. MHI-5 at 6 months

    Time frame: Baseline 2 through 6-month assessment

    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.

  9. Euro-QoL-5 at 3 months

    Time frame: Baseline 2 to 3-month assessment

    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.

  10. Euro-QoL-5 at 6 months

    Time frame: Baseline 2 to 6-month assessment

    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.

  11. Blood Pressure at 3 months

    Time frame: Baseline 1 to 3-month assessment

    Recorded in systolic/diastolic mmHg

  12. Blood Pressure at 6 months

    Time frame: Baseline 1 to 6-month assessment

    Recorded in systolic/diastolic mmHg

  13. Body Mass Index (BMI) at 3 months

    Time frame: Baseline 1 to 3-month assessment

    Measured as BMI = weight (kg) / height (m)^2

  14. Body Mass Index (BMI) at 6 months

    Time frame: Baseline 1 to 6-month assessment

    Measured as BMI = weight (kg) / height (m)^2

Study contacts

Contact information is provided by the study sponsor or research team.

Katherine D Vickery, MD, MSc

CONTACT

[email protected]

6128736852

Sponsors and collaborators

Lead sponsor

Katherine Vickery

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: D-HOMES R01

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jul 29, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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