Transitioning from pediatric to adult epilepsy care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational effort examines the process of transitioning adolescents and young adults with epilepsy from pediatric to adult healthcare. It focuses on how the change in care model and patient-physician relationship affects understanding of epilepsy, treatment options, and self-management. The study uses the EpiTRAQ approach to evaluate transition readiness and coordination between services. Participants include individuals with epilepsy without intellectual disability (with some mild-ID exceptions) who are followed at the Gemelli IRCCS center, with parental or patient consent. The design compares a group receiving structured transition processes to a control group continuing standard care under similar eligibility criteria.

Why it matters

Who can join: the full rules

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).

Where it's running

• Fondazione Policlincio Universitario Agostino Gemelli
  Roma, Italy Recruiting

Study contacts

• Principal investigator: Domenica Immacolata Battaglia — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Domenica Immacolata Battaglia
• Email: domenicaimmacolata.battaglia@policlinicogemelli.it
• Phone: +39 06 3015 5293

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.