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NCT Number: NCT07592676

Transition From Pediatric to Adult Care in Epilepsy

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlincio Universitario Agostino Gemelli

Roma, Italy

Location status: Recruiting

Location contact

Domenica Immacolata Battaglia

PRINCIPAL_INVESTIGATOR

Maria Picilli

SUB_INVESTIGATOR

domenica Immacolata Battaglia

CONTACT

[email protected]

+39 0630155293

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

EpiTRAQ

Diagnostic Test

Clinical and neuropsychological evaluations with standardised and internationally validated questionnaires and interviews, already used in clinical practice.

Other names: QOLIE-31

Primary outcomes

  1. Adult Clinic Attendance Rate

    Time frame: 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.

  2. Return Rate:

    Time frame: 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.

Secondary outcomes

  1. Adult Clinic Attendance Rate and the EpiTRAQ

    Time frame: 36 months

    To Evaluate associations between Adult Clinic Attendance Rate and the EpiTRAQ score for each group.

  2. Return Rate and the EpiTRAQ

    Time frame: 36 months

    To Evaluate associations between the Return Rate and the EpiTRAQ score for each group.

  3. QOLIE-31

    Time frame: 36 months

    Assessment of the Quality of Life with questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Domenica Immacolata Battaglia

CONTACT

[email protected]

+39 06 3015 5293

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: TRANSITA

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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