EpilepsyNCT05825807
Adherence to Pharmacological Antiepileptic Treatment in Adolescence
An observational study of Epilepsy and Treatment Adherence, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
Epilepsy and its drug treatment affect fundamental aspects of an adolescent's lifestyle and can have major consequences on self-esteem and sense of identity. For many adolescents it is difficult to live with epilepsy and medication is difficult to accept; the side effects of medication, in particular even small… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Epilepsy, Treatment Adherence
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 12 Nov 2020to 12 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents with epilepsy treated with antiepileptic drugs for at least one year
Who may be able to join
- Diagnosis of epilepsy
- Age between 12 and 18 years
- On treatment with antiepileptic drugs for at least one year
- Able to understand and complete the questionnaire
Who cannot join
- Subjects with moderate to severe intellectual disability
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Burlo Garofolo
Trieste, 34137
Caterina Zanus, MD, +390403785214, caterina.zanus@burlo.trieste.it
About this study
Official title: Complexity and Specificity of Antiepileptic Drug Treatment and Adherence to Therapy in Adolescence. Pilot Study on Drug Perception and Factors That May Affect it
Epilepsy and its drug treatment affect fundamental aspects of an adolescent's lifestyle and can have major consequences on self-esteem and sense of identity. For many adolescents it is difficult to live with epilepsy and medication is difficult to accept; the side effects of medication, in particular even small changes in mental status and somatic appearance, are particularly feared and poorly tolerated. While it is true that drug-resistant epilepsies exist (about 30% of cases), it is also true that there exists a pseudo-resistance to drug treatment which is due to inadequate administration or poor adherence to treatment. It is estimated that 21 to 42% of patients on antiepileptic treatment don't adhere to the prescribed therapy. The literature emphasizes that non-adherence to treatment is a crucial problem for people with epilepsy, and that the adolescent population is particularly at risk. As with any chronic drug therapy, the therapeutic relationship plays an important role in the treatment of epilepsy. In adolescence, the communication that occurs within the therapeutic relationship takes on peculiar and specific aspects that go beyond the acquisition of anamnestic data and of what is usually reported explicitly in the interview. Communication must be centered on the adolescent's need for independence. Appropriate communication can make the adolescent feel more supported and can encourage him or her to gain self-awareness and control on decisions regarding his or her illness. For the physician, knowledge of the adolescent's point of view is indispensable in order to provide all the necessary information in an appropriate, understandable, and acceptable way, while at the same time acting as a mediator of communication.
The objective of this project is to describe and analyze adolescents' perception of antiepileptic treatment, their awareness of the disease and of the need for drug treatment.
- Conditions
- Epilepsy, Treatment Adherence
- Keywords
- Adolescence, Antiepileptic therapy, Treatment Adherence, Perception
- Medical subject headings
- Epilepsy, Treatment Adherence and Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe adolescent's perception of need for antiepileptic treatment
Evaluated by the Antiepileptic drugs (AED) Necessity scale (6 items evaluating the perceived personal need for antiepileptic drugs). Each item provides 5 possible answers (1=strongly disagree, 2=disagree, 3=uncertain, 4=agree, 5=strongly agree)
Measured: At baseline
To describe adolescent's concerns about potential adverse effects of antiepileptic drugs
Evaluated by the Antiepileptic drugs (AED)-Concerns scale (10 items evaluating concerns about potential adverse effects of antiepileptic drugs). Each item provides 5 possible answers (1=strongly disagree, 2=disagree, 3=uncertain, 4=agree, 5=strongly agree)
Measured: At baseline
Secondary outcomes (4)
To identify clinical factors influencing adolescent's perception of need for antiepileptic treatment
Clinical factors will be collected and association with AED-Necessity scale will be evaluated with multivariate analysis
Measured: At baseline
To identify sociodemographic factors influencing adolescent's perception of need for antiepileptic treatment
Sociodemographic factors will be collected and association with AED-Necessity scale will be evaluated with multivariate analysis
Measured: At baseline
To identify clinical factors influencing adolescent's concerns about potential adverse effects of antiepileptic drugs
Clinical factors will be collected and association with AED-Concerns scale will be evaluated with multivariate analysis
Measured: At baseline
To identify sociodemographic factors influencing adolescent's concerns about potential adverse effects of antiepileptic drugs
Sociodemographic factors will be collected and association with AED-Concerns scale will be evaluated with multivariate analysis
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start12 Nov 2020
- Primary completion12 Nov 2024 (estimated)
- Study completion12 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caterina Zanus, MD, Study director, IRCCS materno infantile Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825807
- Sponsor's protocol ID
- RC 09/19
- Status last verified
- Apr 2023
- First submitted
- 28 Mar 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complexity and Specificity of Antiepileptic Drug Treatment and Adherence to Therapy in Adolescence. Pilot Study on Drug Perception and Factors That May Affect it
- ClinicalTrials.gov ID
- NCT05825807
- Acronym / sponsor ID
- RC 09/19
- Conditions
- Epilepsy, Treatment Adherence
- Keywords
- Adolescence, Antiepileptic therapy, Treatment Adherence, Perception
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 12 Nov 2024 (estimated)
- Study completion
- 12 Nov 2024 (estimated)
- First posted
- 24 Apr 2023 (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.
Epilepsy and its drug treatment affect fundamental aspects of an adolescent's lifestyle and can have major consequences on self-esteem and sense of identity. For many adolescents it is difficult to live with epilepsy and medication is difficult to accept; the side effects of medication, in particular even small changes in mental status and somatic appearance, are particularly feared and poorly tolerated. While it is true that drug-resistant epilepsies exist (about 30% of cases), it is also true that there exists a pseudo-resistance to drug treatment which is due to inadequate administration or poor adherence to treatment. It is estimated that 21 to 42% of patients on antiepileptic treatment don't adhere to the prescribed therapy. The literature emphasizes that non-adherence to treatment is a crucial problem for people with epilepsy, and that the adolescent population is particularly at risk. As with any chronic drug therapy, the therapeutic relationship plays an important role in the treatment of epilepsy. In adolescence, the communication that occurs within the therapeutic relationship takes on peculiar and specific aspects that go beyond the acquisition of anamnestic data and of what is usually reported explicitly in the interview. Communication must be centered on the adolescent's need for independence. Appropriate communication can make the adolescent feel more supported and can encourage him or her to gain self-awareness and control on decisions regarding his or her illness. For the physician, knowledge of the adolescent's point of view is indispensable in order to provide all the necessary information in an appropriate, understandable, and acceptable way, while at the same time acting as a mediator of communication.
The objective of this project is to describe and analyze adolescents' perception of antiepileptic treatment, their awareness of the disease and of the need for drug treatment.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents with epilepsy treated with antiepileptic drugs for at least one year
Key inclusion criteria (4 listed)
- Diagnosis of epilepsy
- Age between 12 and 18 years
- On treatment with antiepileptic drugs for at least one year
- Able to understand and complete the questionnaire
Key exclusion criteria (1 listed)
- Subjects with moderate to severe intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To describe adolescent's perception of need for antiepileptic treatment
Time frame: At baseline
Evaluated by the Antiepileptic drugs (AED) Necessity scale (6 items evaluating the perceived personal need for antiepileptic drugs). Each item provides 5 possible answers (1=strongly disagree, 2=disagree, 3=uncertain, 4=agree, 5=strongly agree)
To describe adolescent's concerns about potential adverse effects of antiepileptic drugs
Time frame: At baseline
Evaluated by the Antiepileptic drugs (AED)-Concerns scale (10 items evaluating concerns about potential adverse effects of antiepileptic drugs). Each item provides 5 possible answers (1=strongly disagree, 2=disagree, 3=uncertain, 4=agree, 5=strongly agree)
4 secondary outcomes
To identify clinical factors influencing adolescent's perception of need for antiepileptic treatment
Time frame: At baseline
To identify sociodemographic factors influencing adolescent's perception of need for antiepileptic treatment
Time frame: At baseline
To identify clinical factors influencing adolescent's concerns about potential adverse effects of antiepileptic drugs
Time frame: At baseline
To identify sociodemographic factors influencing adolescent's concerns about potential adverse effects of antiepileptic drugs
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
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. This study is not recruiting at the moment.
Caterina Zanus, MD study director
IRCCS materno infantile Burlo Garofolo
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 and Treatment Adherence, run by IRCCS Burlo Garofolo 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caterina Zanus, MD (+390403785214, caterina.zanus@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe adolescent's perception of need for antiepileptic treatment (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2023.