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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK139558-01A1 | 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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Randomized controlled trial with a wait list control arm. Participants will be randomized 1:1 to T1CARE or wait list usual care arm. Participants will be recruited from the Yale Adult and Pediatric Diabetes Centers. Patients assigned to T1CARE will receive support from a Community Health Navigator at Project Access-New Haven.
Primary Objective To determine whether the T1CARE intervention improves resolution of health-related social needs compared to usual care.
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T1CARE | Experimental | Patients who are randomized to the intervention arm will be contacted by the Community Health Navigator (CHN) from Project Access-New Haven (PA-NH) (PA-NH). The CHN will conduct an in-depth in-person intake interview to understand the patient's social and clinical need. Additional assessment will include access to insulin, diabetes technologies, and other supplies. The intake will be the basis for a personalized intervention that will respond to patient's unique needs. The initial interview will be audio-recorded to allow for qualitative data analysis. Outcomes will be measured at 6 months. Participants in the T1CARE group will have an option to join a social media platform in addition to receiving individualized support from the CHN. |
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| Standard Care | No Intervention | Participants in the control group will be receive standard screening for SDOH and standard diabetes care at their respective clinics. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T1CARE | Behavioral | The intervention includes navigation by a Community Health Navigator (CHN), who will assess and help address patients' SDOH-related needs, coordinate care, and provide social support. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with resolution of health-related social needs | Resolution of health-related social needs, assessed via adapted Accountable Health Communities (AHC) Model screening questions. Yes/No for resolution. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean score Diabetes Distress Scale (T1-DDS) | The T1-DDS is a 28-item self-report instrument. Each item is rated on a 6-point scale from (1) "not a problem" to (6) "a very significant problem." Total score range 1-6 with higher scores indicating more distress. Investigators will analyze between-group change of the within-group change. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kasia J Lipska, MD | Contact | 203-500-3053 | Kasia.lipska@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kasia Lipska, MD, MHS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Adult Diabetes Center | Recruiting | New Haven | Connecticut | 06520 | United States | |
Metadata associated with the datasets will be submitted to the NIDDK repository or Vivli.
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Scientific data will be shared as soon as possible. Scientific data included in published manuscripts will be available at time of publication. All other data generated will be shared no later than the end of the award. Study data will be stored for 10 years (this is Vivli's policy).
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Participants will complete a standardized Social Determinants of Health (SDOH) screening.
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| Mean score Illness intrusiveness rating scale (IIRS) | IIRS comprised of 13 items that ask patients to rate the degree to which their "illness and/or its treatment" interfere with life domains central to quality of life. Total score range 13 to 91, with higher scores indicating greater illness intrusiveness. Investigators will analyze between-group change of the within-group change. | 6 months |
| Mean score DAWN Impact of Diabetes Profile (DIDP) scale | Quality of life measured by the brief (7 item) DIDP scale (DAWN Impact of Diabetes Profile). Total score range 1-7 with higher scores indicating more negative impact. Investigators will analyze between-group change of the within-group change. | 6 months |
| Mean score Patient satisfaction survey | Patient satisfaction with the intervention will be assessed with 2 questions on a 5-point Likert scale that address whether they were satisfied and would recommend the approach used for their care (which could have been T1CARE or usual care alone) to other patients. Total score range 1-5, higher scores indicate more satisfaction. | 6 Months |
| Change in HbA1c | Change in HbA1c at baseline and 6 months. Investigators will analyze between-group change of the within-group change. | 6 months |
| Yale Children's Diabetes Center |
| Recruiting |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |