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

Yale University

Status: Not yet enrolling

Conditions: Type 1 Diabetes

Treatments: Behavioral: T1CARE

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07059806

1R01DK139558-01A1 (U.S. NIH Grant/Contract)

2000040438

Details and patient eligibility

About

Parallel-arm 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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• report at least 1 health-related social need on a screening questionnaire
• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

T1CARE

Experimental group

Description:

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.

Treatment:

Behavioral: T1CARE

Standard Care

No Intervention group

Description:

Participants in the control group will receive standard diabetes care at their respective clinics.