Adherence to Pharmacological Antiepileptic Treatment in Adolescence

NCT05825807 | Unknown

• 1 other identifier: RC 09/19
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Adolescence; Antiepileptic therapy; Treatment Adherence; Perception

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• To identify clinical factors influencing adolescent's perception of need for antiepileptic treatment

  At baseline

• To identify sociodemographic factors influencing adolescent's perception of need for antiepileptic treatment

  At baseline

• To identify clinical factors influencing adolescent's concerns about potential adverse effects of antiepileptic drugs

  At baseline

• To identify sociodemographic factors influencing adolescent's concerns about potential adverse effects of antiepileptic drugs

  At baseline

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents with epilepsy treated with antiepileptic drugs for at least one year

You may qualify if:

• 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

You may not qualify if:

• Subjects with moderate to severe intellectual disability

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

IRCCS Burlo Garofolo

Trieste, 34137, Italy

RECRUITING

MeSH Terms

Conditions

Epilepsy; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Health Behavior; Behavior

Study Officials

• Caterina Zanus, MD

  IRCCS materno infantile Burlo Garofolo

  STUDY DIRECTOR

Central Study Contacts

Caterina Zanus, MD

CONTACT

+390403785214; caterina.zanus@burlo.trieste.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 24, 2023
• Study Start: November 12, 2020
• Primary Completion: November 12, 2024
• Study Completion: November 12, 2024
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

IT (1)