Transdisciplinary Care for Young Adults With Type 1 Diabetes

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Glycemic level [Срок оценки: Baseline, 6-months, 12-months]
• Transition readiness [Срок оценки: Baseline, 6-months, 12-months]
• Transition outcomes [Срок оценки: 6-months, 12-months]
• Time to First Adult Care Visit [Срок оценки: 6-months, 12-months]
• Continuity of care [Срок оценки: 6-months, 12-months]

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 2 центра

• Nemours Children's Health, Delaware — Wilmington
• Nemours Children's Health, Florida — Orlando

Идентификаторы

NCT: NCT06172166 · JDRF_TCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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