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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
256
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).
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, United States
RECRUITINGChange 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
Time frame: From Baseline 1 to Month 3 assessment
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline 2 to 6-month assessment
Blood Pressure at 3 months
Recorded in systolic/diastolic mmHg
Time frame: Baseline 1 to 3-month assessment
Blood Pressure at 6 months
Recorded in systolic/diastolic mmHg
Time frame: Baseline 1 to 6-month assessment
Body Mass Index (BMI) at 3 months
Measured as BMI = weight (kg) / height (m)\^2
Time frame: Baseline 1 to 3-month assessment
Body Mass Index (BMI) at 6 months
Measured as BMI = weight (kg) / height (m)\^2
Time frame: Baseline 1 to 6-month assessment
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