Transition From Pediatric to Adult Epilepsy Care

NCT ID: NCT06778772

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-06-01

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.

Conditions

Epilepsy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

transition pathway to adult care services for epilepsy patients.

This proposal aims to create a coordinated and shared transition pathway between pediatric and adult epilepsy services, addressing the needs of patients with chronic conditions. The primary objective is to assess the readiness of both patients and their caregivers for the transition, by comparing the Transition Readiness Assessment (TRAQ) questionnaire results between the last pediatric neuropsychiatric visit and the first adult neurology visit. Secondary objectives include evaluating changes in emotional-behavioral issues and quality of life, using the CBCL, YSR, and PedsQoL questionnaires. Assessments will be conducted at both pediatric and adult epilepsy services. The ultimate goal of the transition protocol is to improve care and outcomes for adolescents and young adults during the transition, focusing on emotional-behavioral and psychosocial aspects, and to develop a best-practice model that could influence future guidelines.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS National Neurological Institute "C. Mondino" Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valentina De Giorgis, MD

Role: PRINCIPAL_INVESTIGATOR

Child and Adolescent Epileptology

Locations

Child Neuropsichiatry

Pavia, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Valentina De Giorgis

Role: CONTACT

valentina.degiorgis@mondino.it

0382380289 ext. 0039

Cinzia Fattore, MD

Role: CONTACT

cinzia.fattore@mondino.it

0382380385 ext. 0039

Facility Contacts

Valentina De Giorgis, MD

Role: primary

valentina.degiorgis@mondino.it

0382 380289 ext. 0039

Cinzia Fattore, MD

Role: backup

cinzia.fattore@mondino.it

0382 380385 ext. 0039

References

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.

Reference Type: BACKGROUND

PMID: 28681381 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25169716 (View on PubMed)

Other Identifiers

tra epi

Identifier Type: -

Identifier Source: org_study_id