T1CARE: A Trial of a Novel Intervention to Address Social Determinants of Health in Young Adults With Type 1 Diabetes

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07059806
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Sep 5, 2025
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: T1CARE
    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.
  • No Intervention: Standard Care
    Participants in the control group will be receive standard screening for SDOH and standard diabetes care at their respective clinics.

Primary Outcome Measure

Number of participants with resolution of health-related social needs [ Time Frame: 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale Adult Diabetes CenterNew HavenConnecticut06520-
Yale Children's Diabetes CenterNew HavenConnecticut06520-

Find similar trials in New Haven, CT

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Yale Adult Diabetes Center· New Haven, CTYale Children's Diabetes Center· New Haven, CT

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