T1CARE: A Trial of a Novel Intervention to Address Social Determinants of Health in Young Adults With Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: T1CARE.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
T1CARE: A Randomized Trial of a Novel Intervention to Address Social Determinants of Health in Young Adults With Type 1 Diabetes
Overview
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
- Behavioral T1CARE
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.
Primary outcome measures
- Number of participants with resolution of health-related social needs [Time frame: 6 months]
Secondary outcome measures (5)
- Mean score Diabetes Distress Scale (T1-DDS) [Time frame: 6 months]
- Mean score Illness intrusiveness rating scale (IIRS) [Time frame: 6 months]
- Mean score DAWN Impact of Diabetes Profile (DIDP) scale [Time frame: 6 months]
- Mean score Patient satisfaction survey [Time frame: 6 Months]
- Change in HbA1c [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Yale Adult Diabetes Center — New Haven
- Yale Children's Diabetes Center — New Haven
Identifiers
NCT: NCT07059806 · 2000040438 · 1R01DK139558-01A1