Clinical trial NCT06172166: Transdisciplinary Care for Young Adults With Type 1 Diabetes
Official title: Transdisciplinary Care for Young Adults With Type 1 Diabetes Transitioning to Adult Healthcare
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: Albert Einstein College of Medicine
name: Juvenile Diabetes Research Foundation
First posted: 2023-12-15
Enrollment: 80
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 1 diabetes for at least 6 months
* Approaching their last visit with their pediatric type 1 diabetes healthcare provider. They will have their final visit with their pediatric T1D provider within about a month of enrollment in the study.
* English fluency

Exclusion Criteria:

* Another systemic chronic medical illness except celiac disease, autoimmune thyroiditis, microalbuminuria, hypertension, or well-managed asthma
* Developmental disability limiting independent living

We are recruiting eligible individuals through Nemours and remotely.

Primary outcomes:
measure: Glycemic level
timeFrame: Baseline, 6-months, 12-months
measure: Transition readiness
timeFrame: Baseline, 6-months, 12-months
measure: Transition outcomes
timeFrame: 6-months, 12-months
measure: Time to First Adult Care Visit
timeFrame: 6-months, 12-months
measure: Continuity of care
timeFrame: 6-months, 12-months
Secondary outcomes:
measure: Diabetes distress
timeFrame: Baseline, 6-months, 12-months
measure: Acute care utilization
timeFrame: 6-months, 12-months
measure: Level 3 (Severe) Hypoglycemia
timeFrame: 6-months, 12-months
measure: Diabetic Ketoacidosis
timeFrame: 6-months, 12-months
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours Children's Health, Delaware
state: Delaware
city: Orlando
country: United States
facility: Nemours Children's Health, Florida
state: Florida
Study officials:
References: