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Clinical Trials/NCT06172166
NCT06172166
Recruiting
Not Applicable

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

Nemours Children's Clinic2 sites in 1 country80 target enrollmentApril 17, 2024
ConditionsType 1 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes
Sponsor
Nemours Children's Clinic
Enrollment
80
Locations
2
Primary Endpoint
Time to First Adult Care Visit
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 17, 2024
End Date
July 31, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jessica Pierce

Senior Research Scientist

Nemours Children's Clinic

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.

Outcomes

Primary Outcomes

Time to First Adult Care Visit

Time Frame: 6-months, 12-months

Self-report and medical record review of the time between the last pediatric T1D care visit and the first adult T1D care visit

Glycemic level

Time Frame: Baseline, 6-months, 12-months

HbA1c via mailed dried blood spot (DBS) kits

Transition readiness

Time Frame: Baseline, 6-months, 12-months

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.

Continuity of care

Time Frame: 6-months, 12-months

Self-report and medical record review of the number of visits in adult T1D care since last study visit

Transition outcomes

Time Frame: 6-months, 12-months

Healthcare Transition Outcomes Inventory (HCTOI): self-report of perceived level of success on multiple dimensions of healthcare transition outcomes

Secondary Outcomes

  • Diabetic Ketoacidosis(6-months, 12-months)
  • Diabetes distress(Baseline, 6-months, 12-months)
  • Acute care utilization(6-months, 12-months)
  • Level 3 (Severe) Hypoglycemia(6-months, 12-months)

Study Sites (2)

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