Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06172166
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2023-12-07
Brief Title:
Transdisciplinary Care for Young Adults With Type 1 Diabetes
Sponsor:
Nemours Childrens Clinic
Organization:
Nemours Childrens Clinic
Study Overview
Official Title:
Transdisciplinary Care for Young Adults With Type 1 Diabetes Transitioning to Adult Healthcare
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TCT
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 schoolwork and other changesdemands 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None