Transdisciplinary Care for Young Adults With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— TCT  

Official title:

Transdisciplinary Care for Young Adults With Type 1 Diabetes Transitioning to Adult Healthcare

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06172166
• Other study ID #: JDRF_TCT
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2024
• Est. completion date: July 31, 2026

Study information

• Verified date: April 2024
• Source: Nemours Children's Clinic
• Contact: Jessica Pierce, PhD
• Phone: 407-402-6562
• Email: jessica.pierce[@]nemours.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 application, we propose to test 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2026
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 20 Years

Eligibility

Inclusion Criteria:

• diagnosed with T1D for at least 6 months

• approaching discharge from pediatric T1D specialty care as defined by the young adult's pediatric T1D provider verifies that the young adult's upcoming scheduled pediatric T1D specialty care visit is the young adult's last planned pediatric T1D specialty care visit

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• Transdisciplinary Care for Transition
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.

Locations

Country	Name	City	State
United States	Nemours Children's Health	Orlando	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Nemours Children's Clinic	Albert Einstein College of Medicine, Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic level	HbA1c via mailed dried blood spot (DBS) kits	Baseline, 6-months, 12-months
Primary	Transition readiness	Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY): self-report of confidence of T1D health knowledge and skills needed for transition.	Baseline, 6-months, 12-months
Primary	Transition outcomes	Healthcare Transition Outcomes Inventory (HCTOI): self-report of perceived level of success on multiple dimensions of healthcare transition outcomes	6-months, 12-months
Primary	Time to First Adult Care Visit	Self-report and medical record review of the time between the last pediatric T1D care visit and the first adult T1D care visit	6-months, 12-months
Primary	Continuity of care	Self-report and medical record review of the number of visits in adult T1D care since last study visit	6-months, 12-months
Secondary	Diabetes distress	Diabetes Distress Scale for Adults with T1D (T1-DDS): self-report of emotional distress associated with the ongoing worries, burdens, and concerns of living with T1D	Baseline, 6-months, 12-months
Secondary	Acute care utilization	Self-report and medical record review of the number of T1D-related emergency department visits, urgent care visits, and hospital admissions (and reason why) since last study visit	6-months, 12-months
Secondary	Level 3 (Severe) Hypoglycemia	Self-report and medical record review of the number of severe hypoglycemic events characterized by altered mental status and/or physical status requiring assistance since last study visit	6-months, 12-months
Secondary	Diabetic Ketoacidosis	Self-report and medical record review of the number of episodes of DKA since last study visit.	6-months, 12-months