Adherence to Pharmacological Antiepileptic Treatment in Adolescence

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05825807
• Other study ID #: RC 09/19
• Status: Recruiting
• Start date: November 12, 2020
• Est. completion date: November 12, 2024

Study information

• Verified date: April 2023
• Source: IRCCS Burlo Garofolo
• Contact: Caterina Zanus, MD
• Phone: +390403785214
• Email: caterina.zanus[@]burlo.trieste.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 12, 2024
• Est. primary completion date: November 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Treatment Adherence

Locations

Country	Name	City	State
Italy	IRCCS Burlo Garofolo	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	At baseline
Primary	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)	At baseline
Secondary	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	At baseline
Secondary	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	At baseline
Secondary	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	At baseline
Secondary	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	At baseline