Clinical trial NCT06778772: Transition From Pediatric to Adult Epilepsy Care
Official title: Transition to Adult Care in Epilepsy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy
Keywords: epilepsy
transition
Lead sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 90
Sex: ALL
Minimum age (years): 17
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient with epilepsy primary care clinic

Brief summary: The goal of this observational study is to assess the preparation of the caregiver and the patient for the transition, by comparing the results of the Transition Readiness Assessment (TRAQ) questionnaire at the time of the last pediatric neuropsychiatric visit, which is then repeated at the first adult epilepsy neurology visit.

The assessments will be conducted at the last evaluation at the pediatric epilepsy service and repeated at the first visit to the adult epilepsy service.

Detailed description: Epilepsy is a common pediatric neurological condition, with an incidence of 5-7 cases per 10,000 children and adolescents. In many cases, epilepsy does not remit in adulthood, requiring a transition from pediatric to adult epilepsy care. This transition should ideally be a planned and coordinated process addressing the patient's medical, psychosocial, and educational needs.

At the IRCCS C. Mondino Institute, around 700 pediatric epilepsy patients are followed, many with complex, genetically-based epilepsy and neuropsychiatric comorbidities. Transition programs, though essential, are challenging to implement, as pediatric and adult services often operate independently.

The transition period offers an opportunity for reassessment of care and the management of comorbidities, as well as counseling on aspects like education and independence. Psychiatric comorbidities can complicate the transition and negatively impact patients' quality of life. The Mondino Institute has developed a collaborative transition model involving both pediatric neuropsychiatrists and adult neurologists to address these challenges and better manage psychiatric comorbidities, ensuring a smoother transition to adult care.

The primary objective is to improve the multidisciplinary care of patients with epilepsy and psychiatric comorbidities, by implementing specific diagnostic and therapeutic evaluations for these comorbidities in patients transitioning from the pediatric and adolescent epilepsy center to the adult epilepsy service.

Secondary objectives include:

Defining the management pathway for psychiatric comorbidities in patients transitioning to adult epilepsy services, by identifying suitable structures and professionals for psychiatric and rehabilitative follow-up.

Optimizing the selection of specific pharmacological therapies for medium- to long-term maintenance.

In summary, the focus is on improving the care and treatment of epilepsy patients with psychiatric comorbidities, ensuring proper follow-up and therapeutic planning as they transition from pediatric to adult care.

Eligibility criteria: \*\*Inclusion Criteria:\*\*

* Patients aged 17 or 18 years.
* Diagnosed with focal or generalized epilepsy, regardless of etiology and neuropsychological, neuropsychiatric, or internal comorbidities.
* Those for whom continued epileptology follow-up is required according to standard care guidelines.

\*\*Exclusion Criteria:\*\*

* Patients undergoing EEG only for the detection of EEG abnormalities without a diagnosis of epilepsy.
* Patients for whom the last neuropsychiatric evaluation does not recommend continued epileptology follow-up (patients considered "cured" from epilepsy according to ILAE guidelines).

Primary outcomes:
measure: readiness for transition evaluated throughout Transition Readiness Assessment Questionnaire (TRAQ)
timeFrame: 1 year
Secondary outcomes:
measure: to measure the efficacy of the transition process from pediatric to adult care using Transition Success in Childhood and Adolescence (TSCA)
timeFrame: 1 year
measure: To assess quality of life among patients and their families using Pediatric Quality of Life Inventory (PedsQL)
timeFrame: 1 year
measure: Behavioral and emotional issues will be evaluated by comparing the results of the Achenbach Child Behavior Checklist (ABCL) and Achenbach System of Empirically Based Assessment (ASR)
timeFrame: 1 year
measure: To understand the factors influencing transition readiness and to identify potential barriers, the Transition NEEDS Questionnaire will be developed.
timeFrame: 1 year
measure: To assess the qualitative aspects of the transition phase througout a qualitative scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Child Neuropsichiatry
Study officials:
affiliation: Child and Adolescent Epileptology
name: Valentina De Giorgis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andrade DM, Bassett AS, Bercovici E, Borlot F, Bui E, Camfield P, Clozza GQ, Cohen E, Gofine T, Graves L, Greenaway J, Guttman B, Guttman-Slater M, Hassan A, Henze M, Kaufman M, Lawless B, Lee H, Lindzon L, Lomax LB, McAndrews MP, Menna-Dack D, Minassian BA, Mulligan J, Nabbout R, Nejm T, Secco M, Sellers L, Shapiro M, Slegr M, Smith R, Szatmari P, Tao L, Vogt A, Whiting S, Carter Snead O 3rd. Epilepsy: Transition from pediatric to adult care. Recommendations of the Ontario epilepsy implementation task force. Epilepsia. 2017 Sep;58(9):1502-1517. doi: 10.1111/epi.13832. Epub 2017 Jul 6.
citation: Borlot F, Tellez-Zenteno JF, Allen A, Ali A, Snead OC 3rd, Andrade DM. Epilepsy transition: challenges of caring for adults with childhood-onset seizures. Epilepsia. 2014 Oct;55(10):1659-66. doi: 10.1111/epi.12752. Epub 2014 Aug 28.