Clinical trial NCT05825807: Adherence to Pharmacological Antiepileptic Treatment in Adolescence
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Treatment Adherence
Keywords: Adolescence
Antiepileptic therapy
Treatment Adherence
Perception
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents with epilepsy treated with antiepileptic drugs for at least one year

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Subjects with moderate to severe intellectual disability

Primary outcomes:
measure: To describe adolescent's perception of need for antiepileptic treatment
timeFrame: At baseline
measure: To describe adolescent's concerns about potential adverse effects of antiepileptic drugs
timeFrame: At baseline
Secondary outcomes:
measure: To identify clinical factors influencing adolescent's perception of need for antiepileptic treatment
timeFrame: At baseline
measure: To identify sociodemographic factors influencing adolescent's perception of need for antiepileptic treatment
timeFrame: At baseline
measure: To identify clinical factors influencing adolescent's concerns about potential adverse effects of antiepileptic drugs
timeFrame: At baseline
measure: To identify sociodemographic factors influencing adolescent's concerns about potential adverse effects of antiepileptic drugs
timeFrame: At baseline
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: IRCCS Burlo Garofolo
Study officials:
affiliation: IRCCS materno infantile Burlo Garofolo
name: Caterina Zanus, MD
role: STUDY_DIRECTOR
References: