Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes, Homelessness, Behavioral Activation
Brief 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. 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.
Interventions
BEHAVIORALDiabetes 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.
BEHAVIORALEnhanced 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).
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Katherine Vickery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c at 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| HbA1c at 6 months | 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 |
| HbA1c at 12 months | 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 |
| Diabetes self-care and medication adherence (DSMQ) - 3 months | 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. |
| Diabetes self-care and medication adherence (DSMQ) - 6 months | 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. |
| Difficulties with diabetes management (PAID-5) at 3 months | 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. |
| Difficulties with diabetes management (PAID-5) at 6 months | 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. |
| MHI-5 at 3 months | 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. |
| MHI-5 at 6 months | 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. |
| Euro-QoL-5 at 3 months | 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. |
| Euro-QoL-5 at 6 months | 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. |
| Blood Pressure at 3 months | Baseline 1 to 3-month assessment | Recorded in systolic/diastolic mmHg |
| Blood Pressure at 6 months | Baseline 1 to 6-month assessment | Recorded in systolic/diastolic mmHg |
| Body Mass Index (BMI) at 3 months | Baseline 1 to 3-month assessment | Measured as BMI = weight (kg) / height (m)\^2 |
| Body Mass Index (BMI) at 6 months | Baseline 1 to 6-month assessment | Measured as BMI = weight (kg) / height (m)\^2 |
Countries
United States
Contacts
Primary ContactKatherine D Vickery, MD, MSc
Outcome results
None listed