Transition From Pediatric to Adult Epilepsy Care
ConditionEpilepsy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age17-18
SponsorIRCCS National Neurological Institute "C. Mondino" Foundation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
patient with epilepsy primary care clinic
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
transition pathway to adult care services for epilepsy patients.
BehavioralThis 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
readiness for transition evaluated throughout Transition Readiness Assessment Questionnaire (TRAQ)
To evaluate the preparation of patients and caregivers for the transition process, the Transition Readiness Assessment Questionnaire (TRAQ) will be assessed, and scores will be compared across T0, T1, and T2. The TRAQ has a scale range from 0 to 5, where: 0 indicates insufficient readiness for transition; 5 indicates optimal readiness for transition. Higher scores indicate better preparation for the transition process, while lower scores suggest poorer readiness and a need for further support.
Time frame
1 yearSecondary outcomes
1
to measure the efficacy of the transition process from pediatric to adult care using Transition Success in Childhood and Adolescence (TSCA)
To assess the efficacy of the completed transition protocol, the Transition Success in Childhood and Adolescence (TSCA) will be administred. TSCA scores will be compared across T0, T1, and T2. TSCA questionnaire has a scale range from 0 to 100, where: 0 represents the lowest level of transition success (poorest outcome), 100 represents the highest level of transition success (best outcome). Higher scores indicate a better outcome, reflecting greater success in the transition process, while lower scores indicate a poorer outcome and a need for further support.
Time frame
1 year2
To assess quality of life among patients and their families using Pediatric Quality of Life Inventory (PedsQL)
To explore perceptions of quality of life among patients and their families, Pediatric Quality of Life Inventory (PedsQL)scores will be analyzed across T0, T1, and T2. PedsQL has a scale range from 0 to 100, where: - 0 indicates the poorest quality of life, - 100 indicates the best possible quality of life. Higher scores reflect a better perception of quality of life, while lower scores suggest a lower quality of life and may indicate areas for improvement.
Time frame
1 year3
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)
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) between T0 and T2. ABCL is for children and adolescents (ages 1.5-18 years) and involves parent/caregiver reports. ASR is for adolescents (12-18) and adults (18+), and it can be used as a self-report or informant report tool. Scores for both measures typically range from 0 to 3. 0 indicates no problem, 3 indicates a severe problem. Higher scores indicate more significant behavioral or emotional issues, while lower scores suggest fewer or no problems.
Time frame
1 year4
To understand the factors influencing transition readiness and to identify potential barriers, the Transition NEEDS Questionnaire will be developed.
To provide a comprehensive understanding of the factors influencing transition readiness and to identify potential barriers, the Transition NEEDS Questionnaire will be developed. This semi-structured, qualitative interview for clinicians systematically assesses six critical domains: patient and family readiness, diagnostic gaps, therapeutic gaps, social/care support gaps, educational/work-related gaps, psychological/emotional gaps. This tool, grounded in clinical and theoretical literature, offers a systematic and practical method for evaluating the complex needs of patients transitioning from pediatric to adult epilepsy care.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov