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临床试验/NCT06045520
NCT06045520已完成不适用

Effects of Information-Motivation-Behavioral Skills Model on Disease Management of Adolescents With Epilepsy: Randomized Controlled Study

Mersin University2 个研究点 分布在 2 个国家目标入组 42 人开始时间: 2023年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Change in the mean score of adolescents in the epilepsy disease knowledge test

研究概览

简要总结

The adolescent's search for self-discovery and identity in physical, psychosocial, cognitive and emotional areas may become more complex with epilepsy disease management. The adolescent's burden of treatment compliance may lead to poor adherence to the disease and worsen short- and long-term health outcomes. Disease self-management in epilepsy represents the processes required for disease knowledge, seizure control, medication adherence, increasing social support and quality of life, and reducing the negative effects of the disease. Educational training implemented in this period have an effect that increases motivation to gain skills to adapt to the disease. This model argues that knowledge is a basis for behaviour change, but it is not sufficient alone. However, it is argued that people will have the necessary behavioural skills when they are well informed and motivated for effective action. It is aimed to find a statistically significant difference from the scales (Epilepsy Knowledge Test for Adolescents, Seizure Self-Efficacy Status Scale in Children with Epilepsy, Multidimensional Perceived Level of Social Support Scale, Child's Attitude Towards His/her Disease Scale) at the end of the training of adolescents who received an 8-week training program.

详细描述

Research Hypotheses H1: There is a difference between the seizure self-efficacy scale scores of the intervention group based on the IMB model and the control group.

H2: There is a difference between perceived social support of scale scores of the intervention group based on the IMB model and the control group.

H3: There is a difference between child attitude towards illness scale scores of the intervention group based on the IMB model and the control group.

H4: There is a difference between knowledge test for epilepsy disease scale scores of the intervention group based on the IMB model and the control group.

Epilepsy is the most common neurological disease in childhood. Due to the diagnosis in childhood, parents take a more active role in disease management, while the child remains more passive in this process. In this period, the burden of adaptation of the parents to the treatment passes to the adolescent who is in the process of transition from childhood to adulthood. The adolescent's search for self-discovery and identity in physical, psychosocial, cognitive and emotional areas may become more complex with epilepsy disease management. The adolescent's burden of treatment compliance may lead to poor adherence to the disease and worsen short- and long-term health outcomes. Disease self-management in epilepsy represents the processes required for disease knowledge, seizure control, medication adherence, increasing social support and quality of life, and reducing the negative effects of the disease. Adolescents have low personal motivation for disease management and therefore need more social support from parents and peers. Educational training implemented in this period have an effect that increases motivation to gain skills to adapt to the disease. Fisher et al. developed the IBM model in order to develop health behaviour for HIV prevention in adolescents. This model argues that knowledge is a basis for behaviour change, but it is not sufficient alone. However, it is argued that people will have the necessary behavioural skills when they are well informed and motivated for effective action. In the studies conducted, it was determined that the fact that the model was simple, understandable, low cost and clearly defined implementation stages supported adolescents to develop health behaviour skills. When the international and national literature was examined, no training based on the Knowledge Motivation Behaviour model for adolescents with epilepsy was found. The fact that the model is simple, understandable, low cost and clearly defined implementation stages will support the disease management of adolescents. It is thought that adolescents who are well informed and well motivated with the training based on the Knowledge Motivation Behaviour model and who have developed behavioural skills with training can support disease management.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

The participants were unaware of which group they were assigned to. The data will be entered using A and B codes, and the researcher doing the statistical analysis will be blind to the participants' groups.

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

入选标准

  • For adolescents;
  • Those who agree to participate in the study and sign the Informed Voluntary Consent Form
  • Age between 12-18 years
  • Diagnosis of epilepsy
  • No communication barriers (visual, hearing, mental retardation)
  • No other chronic disease other than epilepsy
  • Being literacy

排除标准

  • For adolescents;
  • Refusal to participate in the study
  • Those who do not sign the Informed Volunteer Consent Form
  • Those who do not sign the Informed Volunteer Consent Form
  • Under 12 years old, over 18 years old,
  • No diagnosis of epilepsy
  • Communication disability (visual, hearing, mental retardation)
  • No another chronic disease other than epilepsy
  • Illiteracy

结局指标

主要结局

Change in the mean score of adolescents in the epilepsy disease knowledge test

时间窗: an average of 3 month

The "epilepsy knowledge test for adolescents" developed by the researchers consists of 25 items. The knowledge test includes true and false items. The items were evaluated with item prop. correct and item discrimination index ITEMAN analysis. The reliability coefficient, which provides evidence of the internal consistency of the knowledge test, was found to be KR-20 (Kuder-Richardson) = 0.813.

Change in the mean score of adolescents in the Seizure Self-Efficacy Scale in Children with Epilepsy

时间窗: an average of 3 month

The scale, which was developed by Caplin et al. and whose Turkish validity and reliability study was conducted by Güven and İşler in 2015, is a 15-item 5-point Likert-type scale. It was conducted with children aged 9-18 years with epilepsy and the cronbach alpha value was found to be 0.89. The scale is a 15-item five-point Likert-type scale and the scale items are scored between 1-5. A high score on the scale is interpreted as an improved seizure self-efficacy of the child

Change in the mean score of adolescents in the Multidimensional Perceived Social Support Scale

时间窗: an average of 3 month

The Multidimensional Perceived Social Support Scale was developed by Zimet et al. The Cronbach's alpha coefficient of the scale, whose validity and reliability study was performed by Eker et al. in 2001, was found to be 0.80-0.95. The scale consists of 12 items and evaluates social support received from three different sources. The scale consists of a 7-point Likert scale as "Absolutely no 1,2,3,4,5,5,6,7 Absolutely yes". The scale has a total of three sub-dimensions as family (mother, father, spouse, children and siblings), friend and special person support (dating, oral, fiancé, neighbour, relative, doctor) and each sub-dimension consists of 4 items. The sub-dimension scores are obtained by summing the four items in the sub-dimensions, and the total score is obtained by summing all sub-dimensions. A minimum score of 12 points and a maximum score of 84 points can be obtained from the scale. A high total score indicates a high level of perceived social support

Change in the mean score of adolescents in theChild's Attitude Towards His Own Illness Scale

时间窗: an average of 3 month

The Turkish validity and reliability study of the scale developed by Austin and Huberty was conducted by Ersun and Bolışık. The scale, whose Cronbach Alpha value is 0.79, is a 5-point Likert type and consists of 15 items. The original scale was developed for children aged 8-12 with chronic diseases. However, in a systematic review of the scale, it was stated that it could be used safely between the ages of 8 and 22. 4 of the 13 items are bipolar adjectives (Very Good, Somewhat Good, Not Sure, Somewhat Bad, Very Bad) and 9 are from options expressing how often they experience the positive and negative aspects of having a chronic disease (Very Often, Often, Sometimes , Not Often, Never). Among the scale items scored between 1 and 5, 1 and 2 indicate negative attitude, 3 indicate neutral attitude, and 4 and 5 indicate positive attitude.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ozlem Guzel Polat

PhD (c), Nursing

Mersin University

研究点 (2)

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