Effectiveness of the Diabetes Homeless Medication Support (D-HOMES) Program on Diabetes Management (D-HOMES R01)

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 Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Enhanced Usual Care/ Education; Behavioral: Diabetes Homeless Medication Support

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine D Vickery, MD, MSc; Phone Number: 6128736852; Email: katherine.vickery@hcmed.org

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Recruiting
      • Hennepin Healthcare Research Institute
      • Contact: Katherine D Vickery, MD, MSc; Phone Number: 612-873-6852; Email: katherine.vickery@hcmed.org
      • Principal Investigator: Katherine D Vickery, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Enhanced Usual Care/Education Session; Brief one-on-one diabetes education session provided by a diabetes wellness coach.	Behavioral: 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).
Experimental: Diabetes Homeless Medication Support (D-HOMES); 10 one-on-one behavioral treatments by a diabetes wellness coach.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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.	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.	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.	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.	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.	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.	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.	Baseline 2 to 6-month assessment
Blood Pressure at 3 months	Recorded in systolic/diastolic mmHg	Baseline 1 to 3-month assessment
Blood Pressure at 6 months	Recorded in systolic/diastolic mmHg	Baseline 1 to 6-month assessment
Body Mass Index (BMI) at 3 months	Measured as BMI = weight (kg) / height (m)^2	Baseline 1 to 3-month assessment
Body Mass Index (BMI) at 6 months	Measured as BMI = weight (kg) / height (m)^2	Baseline 1 to 6-month assessment

Collaborators and Investigators

• Sponsor: Katherine Vickery
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Katherine D Vickery, MD, MSc, Hennepin Healthcare Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: July 21, 2025
• First Submitted That Met QC Criteria: July 21, 2025
• First Posted (Actual): July 29, 2025

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Behavioral Activation; Type 2 Diabetes; Homelessness
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: IRB-FY2024-849; R01DK139152 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No