EpilepsyNCT06778772
Transition From Pediatric to Adult Epilepsy Care
An observational study of Epilepsy, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 18 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- transition pathway to adult care services for epilepsy patients.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2023to 1 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patient with epilepsy primary care clinic
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Child Neuropsichiatry
Pavia, 27100
Valentina De Giorgis, MD, 0382 380289 ext. 0039, valentina.degiorgis@mondino.it
Cinzia Fattore, MD, 0382 380385 ext. 0039, cinzia.fattore@mondino.it
About this study
Official title: Transition to Adult Care in Epilepsy
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.
Read the 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
- Being tested
- transition pathway to adult care services for epilepsy patients.
- Keywords
- epilepsy, transition
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transition pathway to adult care services for epilepsy patients.Behavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
To assess the qualitative aspects of the transition phase througout a qualitative scale
The TRANS-EPI Questionnaire focuses on qualitative aspects of the transition phase, exploring: timing and introduction to the transition process; evaluation of information proovided; expectations from adult neurology care; concerns about continuity of care and autonomy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Jun 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valentina De Giorgis, MD, Principal investigator, Child and Adolescent Epileptology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778772
- Sponsor's protocol ID
- tra epi
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28681381Borlot 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.
PubMed 25169716Giobbe V, Mule G, Zanaboni MP, Ballante E, Brondino N, Celario M, Ferraro F, Lomonaco D, Macina L, Mensi MM, Orlando I, Pasca L, Tartara E, Varesio C, De Giorgis V. Epi-STEP: A multidisciplinary transition model for patients with epilepsy. MethodsX. 2026 Apr 14;16:103914. doi: 10.1016/j.mex.2026.103914. eCollection 2026 Jun.
PubMed 42165072
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transition to Adult Care in Epilepsy
- ClinicalTrials.gov ID
- NCT06778772
- Acronym / sponsor ID
- tra epi
- Conditions
- Epilepsy
- Keywords
- epilepsy, transition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" FoundationUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patient with epilepsy primary care clinic
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | – |
Primary outcome
readiness for transition evaluated throughout Transition Readiness Assessment Questionnaire (TRAQ)
Time frame: 1 year
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.
5 secondary outcomes
to measure the efficacy of the transition process from pediatric to adult care using Transition Success in Childhood and Adolescence (TSCA)
Time frame: 1 year
To assess quality of life among patients and their families using Pediatric Quality of Life Inventory (PedsQL)
Time frame: 1 year
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)
Time frame: 1 year
To understand the factors influencing transition readiness and to identify potential barriers, the Transition NEEDS Questionnaire will be developed.
Time frame: 1 year
To assess the qualitative aspects of the transition phase througout a qualitative scale
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Background: PubMed 28681381Andrade 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.
- Background: PubMed 25169716Borlot 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.
- Derived from this study: PubMed 42165072Giobbe V, Mule G, Zanaboni MP, Ballante E, Brondino N, Celario M, Ferraro F, Lomonaco D, Macina L, Mensi MM, Orlando I, Pasca L, Tartara E, Varesio C, De Giorgis V. Epi-STEP: A multidisciplinary transition model for patients with epilepsy. MethodsX. 2026 Apr 14;16:103914. doi: 10.1016/j.mex.2026.103914. eCollection 2026 Jun.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valentina De Giorgis, MD principal investigator
Child and Adolescent Epileptology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentina De Giorgis (0382380289 ext. 0039, valentina.degiorgis@mondino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
readiness for transition evaluated throughout Transition Readiness Assessment Questionnaire (TRAQ) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06778772, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.