Type 1 Diabetes
Conditions
Brief summary
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.
Detailed description
Primary Objective To determine whether the T1CARE intervention improves resolution of health-related social needs compared to usual care. Secondary Objectives 1. To assess the feasibility and acceptability of the T1CARE intervention. 2. To evaluate the impact of T1CARE on patient-reported outcomes, including diabetes distress, illness intrusiveness, and quality of life. 3. To examine preliminary effects on clinical outcomes, particularly changes in HbA1c.
Interventions
BEHAVIORALT1CARE
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants will complete a standardized Social Determinants of Health (SDOH) screening.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 Diabetes * fluent in Spanish or English who reside in the greater New Haven area
Exclusion criteria
* cognitive impairment and otherwise unable to give written informed consent about participating in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with resolution of health-related social needs | 6 months | Resolution of health-related social needs, assessed via adapted Accountable Health Communities (AHC) Model screening questions. Yes/No for resolution. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean score Diabetes Distress Scale (T1-DDS) | 6 months | 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. |
| Mean score Illness intrusiveness rating scale (IIRS) | 6 months | 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. |
| Mean score DAWN Impact of Diabetes Profile (DIDP) scale | 6 months | 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. |
| Mean score Patient satisfaction survey | 6 Months | 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. |
| Change in HbA1c | 6 months | Change in HbA1c at baseline and 6 months. Investigators will analyze between-group change of the within-group change. |
Countries
United States
Contacts
Primary ContactKasia J Lipska, MD
Outcome results
None listed