Adherence to Pharmacological Antiepileptic Treatment in Adolescence

Recruiting

• Conditions: Epilepsy; Treatment Adherence

• Registration Number: NCT05825807
• Lead Sponsor: IRCCS Burlo Garofolo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-12
• Study First Submitted: 2023-03-28
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-11
• Last Update Submitted: 2023-04-11
• Study First Posted: 2023-04-24
• Last Update Posted: 2023-04-24
• Primary Completion: 2024-11-12
• Study Completion: 2024-11-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To describe adolescent's perception of need for antiepileptic treatment	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	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)

Secondary Outcome Measures

Name	Time	Method
To identify sociodemographic factors influencing adolescent's perception of need for antiepileptic treatment	At baseline	Sociodemographic factors will be collected and association with AED-Necessity scale will be evaluated with multivariate analysis
To identify clinical factors influencing adolescent's concerns about potential adverse effects of antiepileptic drugs	At baseline	Clinical factors will be collected and association with AED-Concerns scale will be evaluated with multivariate analysis
To identify sociodemographic factors influencing adolescent's concerns about potential adverse effects of antiepileptic drugs	At baseline	Sociodemographic factors will be collected and association with AED-Concerns scale will be evaluated with multivariate analysis
To identify clinical factors influencing adolescent's perception of need for antiepileptic treatment	At baseline	Clinical factors will be collected and association with AED-Necessity scale will be evaluated with multivariate analysis

Trial Locations

Locations (1)

IRCCS Burlo Garofolo; 🇮🇹 Trieste, Italy