Adherence to Pharmacological Antiepileptic Treatment in Adolescence

NCT ID: NCT05825807

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-12
• Study Completion Date: 2024-11-12

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.

Conditions

Epilepsy; Treatment Adherence

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caterina Zanus, MD

Role: STUDY_DIRECTOR

IRCCS materno infantile Burlo Garofolo

Locations

IRCCS Burlo Garofolo

Trieste, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Caterina Zanus, MD

Role: CONTACT

caterina.zanus@burlo.trieste.it

+390403785214

Facility Contacts

Caterina Zanus, MD

Role: primary

caterina.zanus@burlo.trieste.it

+390403785214

Other Identifiers

RC 09/19

Identifier Type: -

Identifier Source: org_study_id