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Résztvevőt keres itt: OlaszországFázis nélkül

Transition From Pediatric to Adult Care in Epilepsy

A legfontosabb adatok

Ki végzi
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Hol
Roma (Olaszország)A helyszín megnézése
Azonosító
Állapot
Toboroz
Résztvevők
64 fő, tervezett
Kezdés
2025. nov. 19.
Várható befejezés
2030. dec. 1.
A vizsgálat típusa
Megfigyeléses, 2 csoport
A vizsgált kezelések
  • EpiTRAQ
A regiszteradat frissítve
2026. május 18.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan fiatal és felnőtt epilepsziás embereket keres, akiket egy olasz kórházban követnek, és akik a gyermekellátásból a felnőttellátásba lépnek át. Egy új átmeneti programot vizsgál.

Életkor
A prospektív esetcsoportban legalább 15 éves; a kontrollcsoportban és a retrospektív vizsgálatban legalább 18 éves.
Nem
Férfiak és nők egyaránt részt vehetnek.
A betegség stádiuma
Epilepszia vagy epilepsziás szindrómák, értelmi fogyatékosság nélkül vagy csak enyhe értelmi fogyatékossággal, más betegségekkel vagy azok nélkül. Tuberózis szklerózis komplexumban szenvedők is részt vehetnek.
Korábbi kezelés
Rendszeresen követik a Fondazione Policlinico Universitario A. Gemelli IRCCS kórházban, és ott legalább két korábbi vizit dokumentált.

A részvétel fő kizáró okai

  • Nem vehetnek részt azok, akiket nem követnek rendszeresen a gyógyszerrezisztens epilepsziák nappali kórházában (kevesebb mint két vizit).

A regiszter feltételei, szó szerint

Mind a 16 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • -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)

Helyszínek itt: Olaszország

  • Fondazione Policlincio Universitario Agostino GemelliRoma, OlaszországContact: domenica Immacolata BattagliaRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat 2 csoportja

  • 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.

    Kezelés: EpiTRAQ

  • 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.

    Kezelés: EpiTRAQ

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Transitioning From Pediatric to Adult Care in Epilepsy: Efficacy of a Novel Italian Model
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
A regiszteradat frissítve
2026. május 18.