80 Participants Needed

Transdisciplinary Care for Type 1 Diabetes

(TCT Trial)

Recruiting at 2 trial locations
JP
JC
NM
Overseen ByNicole Morales
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Nemours Children's Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

Is Transdisciplinary Care for Type 1 Diabetes safe for humans?

The research does not provide specific safety data for Transdisciplinary Care for Type 1 Diabetes, but it discusses various models of care aimed at improving safety and quality during the transition from pediatric to adult services.12345

What makes the Transdisciplinary Care for Transition treatment unique for Type 1 Diabetes?

The Transdisciplinary Care for Transition treatment is unique because it focuses on a coordinated approach involving multiple healthcare professionals to support young adults as they move from pediatric to adult diabetes care. This approach aims to address both medical and psychosocial challenges during this critical transition period, which is often marked by unstable blood sugar control and other difficulties.23678

What data supports the effectiveness of the treatment Transdisciplinary Care for Transition for Type 1 Diabetes?

Research shows that structured transition programs for young adults with type 1 diabetes can improve clinic attendance, glycemic control (blood sugar management), and quality of life. Additionally, multidisciplinary self-management interventions have been found effective in managing blood sugar levels in people with type 1 diabetes.1291011

Are You a Good Fit for This Trial?

This trial is for young adults with Type 1 Diabetes who are fluent in English and transitioning from pediatric to adult diabetes care. They must have been diagnosed at least 6 months ago and be approaching their last scheduled pediatric diabetes care visit. Those with certain chronic illnesses or developmental disabilities that limit independence cannot participate.

Inclusion Criteria

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
I have been diagnosed with Type 1 Diabetes for over 6 months.

Exclusion Criteria

Developmental disability limiting independent living
I have a chronic illness, but it's not celiac, thyroid issues, kidney problems, high blood pressure, or controlled asthma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transition Care

Participants receive transdisciplinary care for transition, including visits with a diabetes nurse educator, psychologist, and transition navigator

6 months
3 visits (remote)

Standard Clinical Care

Participants transition to adult T1D care as per their clinic's standard procedures

6 months

Follow-up

Participants are monitored for transition readiness, glycemic levels, and continuity of care

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Transdisciplinary Care for Transition
Trial Overview The study tests a new 'Transdisciplinary Care for Transition' (TCT) model involving a nurse educator, psychologist, and case manager to help manage the healthcare transition. Participants will either receive standard care or three TCT visits over six months after leaving pediatric care.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Transdisciplinary Care for TransitionExperimental Treatment1 Intervention
Group II: Standard Clinical CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials
128
Recruited
18,000+

Juvenile Diabetes Research Foundation

Collaborator

Trials
237
Recruited
142,000+

Albert Einstein College of Medicine

Collaborator

Trials
302
Recruited
11,690,000+

Published Research Related to This Trial

There is a significant lack of empirical research on health care transition (HCT) outcomes in type 1 diabetes (T1D), which is complicated by methodological issues, highlighting the need for a more comprehensive approach.
The authors propose an expanded model for HCT outcomes that includes multiple stakeholder perspectives, which could lead to the development of a standardized index to better assess HCT readiness and improve the design of future interventions.
Topical Review: Advancing Research on the Transition to Adult Care for Type 1 Diabetes.Pierce, JS., Wysocki, T.[2022]
Multidisciplinary self-management interventions for individuals with type 1 diabetes are designed to improve glycemic control, primarily measured by glycated hemoglobin levels, which is crucial for managing the disease effectively.
The review will also assess the impact of these interventions on quality of life and the frequency of adverse events like hypoglycemia and diabetic ketoacidosis, ensuring a comprehensive understanding of their overall effectiveness.
Effectiveness of multidisciplinary led self-management interventions on glycaemic control in people with type 1 diabetes: a systematic review protocol.West, S., Ramis, MA., Burgess, L., et al.[2021]
Structured transition education programs for Type 1 Diabetes showed improvements in glycaemic control and psychological well-being compared to usual care, indicating their potential effectiveness in supporting emerging adults during the transition to self-management.
While multidisciplinary team support and telehealth models reported some benefits in patient engagement and self-management adherence, the overall health outcomes were mixed, highlighting the need for further research on the implementation and acceptability of these transition care models.
Transition models of care for type 1 diabetes: a systematic review.Zurynski, Y., Carrigan, A., Meulenbroeks, I., et al.[2023]

Citations

Topical Review: Advancing Research on the Transition to Adult Care for Type 1 Diabetes. [2022]
Effectiveness of multidisciplinary led self-management interventions on glycaemic control in people with type 1 diabetes: a systematic review protocol. [2021]
Transition models of care for type 1 diabetes: a systematic review. [2023]
Type 1 diabetes mellitus: can coaching improve health outcomes? [2023]
Closing the Gap: Results of the Multicenter Canadian Randomized Controlled Trial of Structured Transition in Young Adults With Type 1 Diabetes. [2022]
Transition From Pediatric to Adult Care for Individuals With Type 1 Diabetes: Opportunities and Challenges. [2023]
Clinical and Psychosocial Outcomes of a Structured Transition Program Among Young Adults With Type 1 Diabetes. [2019]
Multidisciplinary coordinated care for Type 2 diabetes: A qualitative analysis of patient perspectives. [2020]
[Diabetes mellitus at the interface between pediatric and adult medicine]. [2019]
[Building bridges during transition of patients with type 1 diabetes. Adult medical and pediatric point of views]. [2021]
Adult care providers' perspectives on the transition to adult care for emerging adults with Type 1 diabetes: a cross-sectional survey. [2019]
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