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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK139152 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Usual Care/Education Session | Active Comparator | Brief one-on-one diabetes education session provided by a diabetes wellness coach. |
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| Diabetes Homeless Medication Support (D-HOMES) | Experimental | 10 one-on-one behavioral treatments by a diabetes wellness coach. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
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
Willingness to work on medication adherence and diabetes self-care
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katherine D Vickery, MD, MSc | Contact | 6128736852 | katherine.vickery@hcmed.org |
| Name | Affiliation | Role |
|---|---|---|
| Katherine D Vickery, MD, MSc | Hennepin Healthcare Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin Healthcare Research Institute | Recruiting | Minneapolis | Minnesota | 55404 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| 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). |
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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 |
| D004700 | Endocrine System Diseases |