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| Name | Class |
|---|---|
| NYU Langone Health | OTHER |
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This mixed method study includes a Randomized Controlled Trial (RCT) and qualitative methods to assess the impact of a SMS text strategy in diabetes control among persons who experience homelessness.
Diabetes mellitus (DM) is common among persons experiencing homelessness (PEH), often inadequately managed, and carries significant costs. SMS strategies for DM have not been tested among PEH despite the accessibility of mobile phones. This study uses a SMS strategy to offer better communication, education, and information management; improve outreach; facilitate care coordination; explore barriers to care; and support behavior changes. This mixed-methods (RCT and qualitative) study will be implemented in shelter-clinics in New York City in collaboration with community organizations, allowing for sustainability and scalability. Aim 1 will evaluate the efficacy of a 6-month SMS program for DM management versus an attention control on changes in HbA1c and adherence to DM self-care activities, medications, and appointments at 9 months in adult PEH with uncontrolled DM (n=100). Outcomes will be measured at 0, 3, 6, &9 months. Aim 2 will assess patients' and providers' attitudes, acceptability, and experience of the program through semi-structured interviews with PEH and providers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention (INT) will include 6 months of DM management support via SMS texts including reminders for medication adherence, appointments, and DM self-care activities as well as education, and support. |
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| Control | Placebo Comparator | The control (CL) will receive 6 months of texts for general health promotion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | 6 months of diabetes management support via SMS texts including reminders for medication adherence, appointments, and diabetes self-care activities as well as education, and support |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Hemoglobin A1c level | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Days Covered (PDC) | Medication Adherence through Proportion of Days Covered of Medications | 9 months |
| Appointment Adherence | Proportion of appointment adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ramin Asgary, MD, MPH | Contact | 917-684-9331 | raminasgary1@gwu.edu | |
| Leah Bauder, MPH | Contact | 970-682-0940 | leahbaud@gwu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University | Recruiting | Washington D.C. | District of Columbia | 20052 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Intervention versus Control group; Randomized at the Individual level
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| Attention Control | Behavioral | 6 months of texts for general health promotion |
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| 9 months |
| NYU Langone Health | Active, not recruiting | New York | New York | 10003 | United States |