Transdisciplinary Care for Young Adults With Type 1 Diabetes

Part of paid clinical trials in Wilmington, Delaware.

Sponsor
Nemours Children's Clinic
Study ID
NCT06172166
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
17 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transdisciplinary Care for Transition — BEHAVIORAL
    Young adults with T1D will participate in three visits during which they will see a diabetes nurse educator, psychologist, and transition navigator/social worker who will co-deliver care. TCT Visits 1 and 2 will be before the first adult diabetes healthcare visit, during trial months 1 and 2 respectively. These visits will focus on improving transition readiness, establishing care with an adult T1D specialist, and navigating psychosocial barriers to successful transition. TCT Visit 3 will occur after the first adult T1D healthcare visit, within one month of the first adult T1D care visit or during trial month 7 if the visit has not yet occurred. TCT Visit 3 will focus on overcoming barriers to satisfactory adult T1D healthcare.

Study Details

The incidence of type 1 diabetes (T1D) is increasing globally with the most substantial increases occurring in the youngest age groups. A growing number of youths with T1D must therefore transition their healthcare from pediatric to adult T1D care settings as they approach young adulthood. This healthcare transition introduces many challenges because it coincides with a developmental period that is fraught with social, financial, residential, school/work and other changes/demands. Thus, it is not surprising that young adults (YA) with T1D are at risk for suboptimal glycemic levels, the development of diabetes-related complications, and psychosocial issues such as depression, anxiety, and disordered eating. Yet, few evidence-based interventions to assist YA with T1D with this complex healthcare transition exist. In this study, we are testing the feasibility, acceptability, and initial efficacy of a novel transdisciplinary model of care (Transdisciplinary Care for Transition; TCT) in which a diabetes nurse educator, psychologist, and transition navigator (case manager) co-deliver transitional care. TCT addresses the psychological and systems barriers to transition and aims to improve outcomes via better assessment of YA needs and resources, better cross-discipline and YA-provider communication, and better collaboration with YA to resolve problems that cross pediatric and adult healthcare settings. We will recruit 80 YA with T1D during their final visit in pediatric T1D specialty care to participate in a pilot randomized controlled trial during which we will randomize YA to a standard care control group (SCC) or to receive three TCT visits during the 6 months post discharge from pediatric T1D care. In SCC, participants will transition to adult T1D care as usual per their clinic's standard transition procedures. All study procedures can be completed remotely. This includes enrollment, study evaluations, and TCT visits for those randomized to TCT. Thus, we are recruiting individuals from across the United States. Aim 1: Examine the feasibility, acceptability, and fidelity of TCT in YA with T1D. Aim 2: Examine the preliminary efficacy of TCT versus SCC on YA HbA1c, transition readiness and success, and continuity of care and explore for an effect on diabetes distress and acute care utilization.

Key Dates

Start date
Apr 17, 2024
Status verified
Nov 2025
Primary completion
Apr 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Transdisciplinary Care for Transition
  • No Intervention: Standard Clinical Care

Primary Outcome Measure

Glycemic level [ Time Frame: Baseline, 6-months, 12-months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Nemours Children's Health, DelawareWilmingtonDelaware19803
Jessica Pierce
[email protected]
Nemours Children's Health, FloridaOrlandoFlorida32827
Jessica Pierce, PhD
[email protected]

Find similar trials in Wilmington, DE

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Nemours Children's Health, Delaware· Wilmington, DENemours Children's Health, Florida· Orlando, FL

Related Studies