Complexity and Specificity of Antiepileptic Drug Treatment and Adherence to Therapy in Adolescence. Pilot Study on Drug Perception and Factors That May Affect it
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To describe adolescent's perception of need for antiepileptic treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Subjects with moderate to severe intellectual disability
结局指标
主要结局
To describe adolescent's perception of need for antiepileptic treatment
时间窗: 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
时间窗: 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)
次要结局
- 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)
- To identify clinical factors influencing adolescent's perception of need for antiepileptic treatment(At baseline)