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Transition From Pediatric to Adult Care in Epilepsy (TRANSITA)

11 maja 2026 zaktualizowane przez: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Transitioning From Pediatric to Adult Care in Epilepsy: Efficacy of a Novel Italian Model

The transition from pediatric to adult healthcare services for individuals with epilepsy represents a major clinical and organizational challenge. This complexity arises from the heterogeneity of the underlying epileptic disorders and the frequent presence of multiple comorbidities. Furthermore, the process entails a profound shift in the patient-physician relationship, which must be re-established to allow open discussion of sensitive issues and to adapt to a different model of care.

In pediatric settings, medical care is predominantly family-centered, with parents actively involved in the decision-making process. In contrast, adult care is primarily patient-centered, emphasizing individual autonomy and self-management. The **transition** therefore constitutes a structured process designed to prepare adolescents and young adults for adult-oriented healthcare. It aims to enhance their understanding of epilepsy, increase awareness of available treatments, and develop self-management skills that help minimize the long-term psychosocial and medical impact of the disorder.

The **transfer**, by contrast, refers to the formal handover of medical responsibility from pediatric to adult healthcare providers. While transfer is an event, transition represents a multidimensional process that should begin well before the actual shift of care.

Over the past decade, several studies have sought to address the challenges associated with this critical phase by proposing transitional programs based on different organizational models. These structured interventions are designed to bridge the gap between pediatric and adult services, fostering continuity of care and improving clinical outcomes.

A recent and promising example is a **French transitional model**, published following a retrospective study involving 70 persons with epilepsy (PWE). This model provided evidence supporting the feasibility and benefits of a dedicated, multidisciplinary transition program tailored to the specific needs of young individuals with epilepsy.

In contrast, within the Italian scientific and clinical context-particularly in the field of epilepsy-no formally structured or validated transition program has yet been established. This gap underscores the need for the development of standardized national guidelines and the implementation of evidence-based transitional pathways.

A well-designed transition program can significantly facilitate the adjustment of adolescents to adult neurological care, promoting therapeutic adherence, clinical stability, and psychosocial well-being. Ultimately, structured transitional care represents a crucial step toward ensuring continuity, safety, and quality of care for individuals with epilepsy as they move from pediatric to adult health services.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

64

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Włochy
      • Roma, Włochy
        • Rekrutacyjny
        • Fondazione Policlincio Universitario Agostino Gemelli
        • Kontakt:
        • Główny śledczy:
          • Domenica Immacolata Battaglia
        • Pod-śledczy:
          • Maria Picilli

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

People with epilepsy who are transitioning from pediatric care to an adult neurologist's outpatient clinic.

Opis

Inclusion Criteria:

Prospective Study

Case Group:

  • Persons with epilepsy (PWE) or epileptic syndromes (6,7) without intellectual disability (ID); PWE with mild ID, with or without comorbidities; and individuals diagnosed with tuberous sclerosis complex.
  • PWE who are at least 15 years old at the time of the DH BRIDGE admission.
  • PWE who are regularly followed at the Fondazione Policlinico Universitario A. Gemelli IRCCS, with documentation of at least two prior evaluations conducted at the Child Neuropsychiatry Unit.
  • Signed informed consent obtained from the parents or legal guardians, or from the patient if of legal age. In cases where an adult patient is unable to provide informed consent, authorization will be obtained from a parent or legal guardian.
  • Signed assent form from the minor participant.

Control Group:

  • Persons with epilepsy (PWE) or epileptic syndromes (6,7) without intellectual disability (ID); PWE with mild ID, with or without comorbidities; and individuals diagnosed with tuberous sclerosis complex.
  • PWE who are at least 18 years old at the time of their first visit to the Adult Neurology Outpatient Clinic.
  • PWE who are regularly followed at the Fondazione Policlinico Universitario A. Gemelli IRCCS, with documentation of at least two visits at the Day Hospital for Drug-Resistant Epilepsies.
  • Signed informed consent obtained directly from the patient or, in cases of incapacity, from the parents or legal guardian.

Retrospective Study

  • Persons with epilepsy (PWE) or epileptic syndromes without intellectual disability (ID); PWE with mild ID, with or without comorbidities; and individuals diagnosed with tuberous sclerosis complex.
  • PWE who were over 18 years of age at the time of their first visit to the Adult Neurology Outpatient Clinic, and who have completed at least six months of follow-up after that visit. When available, follow-up data at 12 months will also be collected.
  • PWE who have been regularly followed at the Fondazione Policlinico Universitario A. Gemelli IRCCS, with at least two documented visits conducted at the same institution.
  • Signed informed consent obtained directly from the patient or, in cases of incapacity, from the parents or legal guardian.

Exclusion Criteria:

-Patients will be excluded if they are not regularly followed at the Day Hospital for the Diagnosis and Treatment of Drug-Resistant Epilepsies (fewer than two visits).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
CASE group
The study will include persons with epilepsy (PWE) or epileptic syndromes, with or without mild intellectual disability, and individuals with tuberous sclerosis complex. Participants may have comorbidities that do not hinder their participation in transitional care. Eligible subjects must be ≥15 years at the time of the DH BRIDGE and regularly followed at Fondazione Policlinico Universitario A. Gemelli IRCCS (≥2 visits). Informed consent will be obtained from patients or guardians, and assent from minors, ensuring an ethically and clinically appropriate cohort for transitional care evaluation.
Test diagnostyczny: EpiTRAQ
Clinical and neuropsychological evaluations with standardised and internationally validated questionnaires and interviews, already used in clinical practice.
Inne nazwy:
  • QOLIE-31
CONTROL group
The control group will include adults (≥18 years) with epilepsy or epileptic syndromes, with or without mild intellectual disability, and individuals with tuberous sclerosis complex. Participants may have comorbidities that do not interfere with standard adult neurological care. All must be regularly followed at Fondazione Policlinico Universitario A. Gemelli IRCCS, with at least two documented visits. Informed consent will be obtained from each participant or, if incapacitated, from a legal guardian, ensuring a clinically comparable and ethically sound reference group.
Test diagnostyczny: EpiTRAQ
Clinical and neuropsychological evaluations with standardised and internationally validated questionnaires and interviews, already used in clinical practice.
Inne nazwy:
  • QOLIE-31

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Adult Clinic Attendance Rate
Ramy czasowe: 12 months
The percentage of patients (for each group) who attend their first scheduled adult clinic appointment, as organized by the pediatric team. The study aims to compare the Attendance Rate in adult care with a minimum of 6-12 months between case and control groups.
12 months
Return Rate:
Ramy czasowe: 12 months
The percentage of patients (for each group) who request a follow-up visit with their pediatric neurologist or return to the pediatric center after the transfer. The study aims to compare the Return Rate with a minimum of 6-12 months between the case and control groups.
12 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Adult Clinic Attendance Rate and the EpiTRAQ
Ramy czasowe: 36 months
To Evaluate associations between Adult Clinic Attendance Rate and the EpiTRAQ score for each group.
36 months
Return Rate and the EpiTRAQ
Ramy czasowe: 36 months
To Evaluate associations between the Return Rate and the EpiTRAQ score for each group.
36 months
QOLIE-31
Ramy czasowe: 36 months
Assessment of the Quality of Life with questionnaire
36 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Śledczy

  • Główny śledczy: Domenica Immacolata Battaglia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

19 listopada 2025

Zakończenie podstawowe (Szacowany)

1 grudnia 2028

Ukończenie studiów (Szacowany)

1 grudnia 2030

Daty rejestracji na studia

Pierwszy przesłany

18 listopada 2025

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 maja 2026

Pierwszy wysłany (Rzeczywisty)

18 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 maja 2026

Ostatnia weryfikacja

1 listopada 2025

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 7918 (CTEP)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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