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Transition From Pediatric to Adult Care in Epilepsy (TRANSITA)

11 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

64

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Italië
      • Roma, Italië
        • Werving
        • Fondazione Policlincio Universitario Agostino Gemelli
        • Contact:
        • Hoofdonderzoeker:
          • Domenica Immacolata Battaglia
        • Onderonderzoeker:
          • Maria Picilli

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Diagnostische toets: EpiTRAQ
Clinical and neuropsychological evaluations with standardised and internationally validated questionnaires and interviews, already used in clinical practice.
Andere namen:
  • 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.
Diagnostische toets: EpiTRAQ
Clinical and neuropsychological evaluations with standardised and internationally validated questionnaires and interviews, already used in clinical practice.
Andere namen:
  • QOLIE-31

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adult Clinic Attendance Rate
Tijdsspanne: 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:
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adult Clinic Attendance Rate and the EpiTRAQ
Tijdsspanne: 36 months
To Evaluate associations between Adult Clinic Attendance Rate and the EpiTRAQ score for each group.
36 months
Return Rate and the EpiTRAQ
Tijdsspanne: 36 months
To Evaluate associations between the Return Rate and the EpiTRAQ score for each group.
36 months
QOLIE-31
Tijdsspanne: 36 months
Assessment of the Quality of Life with questionnaire
36 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

19 november 2025

Primaire voltooiing (Geschat)

1 december 2028

Studie voltooiing (Geschat)

1 december 2030

Studieregistratiedata

Eerst ingediend

18 november 2025

Eerst ingediend dat voldeed aan de QC-criteria

11 mei 2026

Eerst geplaatst (Werkelijk)

18 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

11 mei 2026

Laatst geverifieerd

1 november 2025

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 7918 (CTEP)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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