T1CARE: A Randomized Trial of a Novel Intervention to Address Social Determinants of Health in Young Adults With Type 1 Diabetes
Yale University
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.
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.
Eligibility
- Age range
- 18–40 years
- Sex
- All
- 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
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.
Locations (2)
- Yale Adult Diabetes CenterNew Haven, Connecticut
- Yale Children's Diabetes CenterNew Haven, Connecticut