The Individual and Family Self Management Theory Based Epilepsy Education Program's Effectiveness

The Effectiveness of The Education Program Based on The Individual and Family Self Management Theory Given For Epilepsy Adolescents and Parents: Randomized Controlled Trial

The aim of the study; to determine the effect of education program given to adolescents diagnosed with epilepsy and their parents based on Ryan and Sawin's individual and family self-management theory, on adolescents 'attitudes towards disease, self-efficacy, quality of life and parents' nurse-parent support levels.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Epilepsy; Seizure; Self Management
• Intervention / Treatment: Behavioral: Epilepsy Education Programme

Detailed Description

In addition to the expected effects of epilepsy on children, the course of the disease and the course of the child's life will change as the duration of life with the disease increases. In epilepsy, it is necessary to develop self-management behaviors in order to facilitate adaptation to the disease, to encourage seizure control and to increase the quality of life. Regular repetition of the trainings created within the framework of a certain plan to improve self-management behaviors is one of the recommended steps to strengthen the individual with chronic disease in the disease process. This randomized controlled study including aged 12-18 adolescents with a diagnosis of epilepsy, monotherapy, mental retardation without cerebral palsy, and no secondary disease and their parents. However, there isn't enough published research examining the effect of education program given to adolescents diagnosed with epilepsy and their parents based on Ryan and Sawin's individual and family self-management theory, on adolescents 'attitudes towards disease, self-efficacy, quality of life and parents' nurse-parent support levels.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Meram
    • Konya, Meram, Turkey, 42090
      • Necmettin Erbakan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Having a diagnosis of epilepsy for at least 6 months,
• Being in the age range of 12-18 years,
• Cerebral palsy, attention deficit, lack of mental retardation, except for a different physical or epilepsy,
• Receiving monotherapy treatment for epilepsy
• To be able to communicate in Turkish

Exclusion Criteria:

• Cerebral palsy, attention deficit, mental retardation other than epilepsy,
• Patients who are over the age of 18 or who switch to an adult care program,
• Not being open to communication and cooperation, not taking polytherapy
• Adolescents not continuing the monitoring phase or wanting to stop working at any stage,
• Prior history of seizures due to screen exposure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group: Epilepsy education program; The training prepared for epilepsy will be held in 3 main modules and 5 sessions with two weeks intervals. Each session will last 25 minutes. Trainings will be given to adolescents and their parents online.	Behavioral: Epilepsy Education Programme; Firstly the Child Introduction Form and Parent Information Form were applied. Then the Child's Attitude Towards Self-Disease Scale, Seizure Self-Efficacy Scale for Children, Quality of Life Scale for Children were filled to children. Nurse-Parent Support Scale were applied to the parents in the Pretest and Post Test data.
No Intervention: Control Group; The control group will receive standard epilepsy treatment without any training intervention. The group did not receive any other intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Introduction Form	The form consists of 15 questions that question the content dimension (risk factors specific to the disease, factors specific to the physical and social environment, individual and familial factors) and the process dimension concepts (disease-specific knowledge and beliefs, self-regulation, social facilitation).	First measurement - Before education programme (1st week)
Development of the Child Attitude Toward Illness Scale	Child Attitude Toward Illness Scale was developed by Austin (1993) to measure the attitudes of children with chronic diseases towards their disease. The validity and reliability of the 13-item single-dimension scale was conducted by Ersun and Bolisik (2012) with children aged 9-17 years with epilepsy. The average score that can be obtained from the scale varies between 1 and 5. The average score of 1 and 2 indicates negative attitude, 3 indicates neutral attitude, 4 and 5 indicate positive attitude.	First measurement - Before education programme (1st week)
Seizure Self-Efficacy Scale for Children	Seizure Self-efficacy Scale for Children was developed by Caplin et al. (2002) and adapted to Turkish by Tutar Güven and İşler Dalgıç (Tutar Güven and İsler 2015). It was conducted with children aged 9-18 years with epilepsy and the Cronbach's alpha value of the scale was 0.89. The scale consists of a single dimension with a 15-item five-point Likert structure and the scale items are scored between 1-5. indicates that it is.	First measurement - Before education programme (1st week)
The Children's Quality of Life Scale	The Children's Quality of Life Scale was developed in 2001 by Varni et al. For adolescents aged 13-18. The internal consistency coefficient of the scale varies between 0.80-0.88. The Turkish validity and reliability study of the scale was conducted by Çakın Memik et al. In 2007 and the internal consistency coefficient was found to be 0.82. PedsQL, which is one of the general quality of life scales, is a quality of life scale suitable for use in both healthy and ill adolescents. It is a five-point Likert-type scale consisting of 23 items that determines the health-related quality of life of adolescents aged 13-18.	First measurement - Before education programme (1st week)
Parents Information Form	This form was prepared by the researchers in line with the literature. In the form, the individual and self management theory consists of 15 questions regarding the concepts of content and process dimension.	First measurement - Before education programme (1st week)
Nurse-Parent Support Scale	The Nurse Parent Support Scale, developed by Miles et al. (1999) and tested by Yigit et al in 2017, consists of 21 items in a five-point likert structure. There is no reverse item in the scale that measures perceived nurse support by parents. The scale consists of four sub-dimensions. The scale consists of four sub-dimensions. These; It consists of 21 items in total: "Information and Communication Support", "Emotional Support", "Respect Support", "Quality Care".	First measurement - Before education programme (1st week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of the Child Attitude Toward Illness Scale	Development of the Child Attitude Toward Illness Scale was developed by Austin (1993) to measure the attitudes of children with chronic diseases towards their disease. The validity and reliability of the 13-item single-dimension scale was conducted by Ersun and Bolisik (2012) with children aged 9-17 years with epilepsy. The average score that can be obtained from the scale varies between 1 and 5. The average score of 1 and 2 indicates negative attitude, 3 indicates neutral attitude, 4 and 5 indicate positive attitude.	Second measurement - After education programme (10th week)
Seizure Self-Efficacy Scale for Children	Seizure Self-efficacy Scale for Children was developed by Caplin et al. (2002) and adapted to Turkish by Tutar Güven and İşler Dalgıç (Tutar Güven and İsler 2015). It was conducted with children aged 9-18 years with epilepsy and the Cronbach's alpha value of the scale was 0.89. The scale consists of a single dimension with a 15-item five-point Likert structure and the scale items are scored between 1-5. indicates that it is.	Second measurement - After education programme (10th week)
The Children's Quality of Life Scale	The Children's Quality of Life Scale was developed in 2001 by Varni et al. For adolescents aged 13-18. The internal consistency coefficient of the scale varies between 0.80-0.88. The Turkish validity and reliability study of the scale was conducted by Çakın Memik et al. In 2007 and the internal consistency coefficient was found to be 0.82. PedsQL, which is one of the general quality of life scales, is a quality of life scale suitable for use in both healthy and ill adolescents. It is a five-point Likert-type scale consisting of 23 items that determines the health-related quality of life of adolescents aged 13-18.	Second measurement - After education programme (10th week)
Nurse-Parent Support Scale	The Nurse Parent Support Scale, developed by Miles et al. (1999) and tested by Yigit et al in 2017, consists of 21 items in a five-point likert structure. There is no reverse item in the scale that measures perceived nurse support by parents. The scale consists of four sub-dimensions. The scale consists of four sub-dimensions. These; It consists of 21 items in total: "Information and Communication Support", "Emotional Support", "Respect Support", "Quality Care".	Second measurement - After education programme (10th week)

Collaborators and Investigators

• Sponsor: KTO Karatay University
• Investigators: Principal Investigator: Hilal Kurt Sezer, Master, KTO Karatay University; Study Director: Sibel KUCUKOGLU, Assoch prof, Selcuk University; Study Director: Abdullah Canbal, Dr, Necmettin Erbakan University

Publications and helpful links

General Publications

• Austin JK, Huberty TJ. Development of the Child Attitude Toward Illness Scale. J Pediatr Psychol. 1993 Aug;18(4):467-80. doi: 10.1093/jpepsy/18.4.467.
• Tutar Guven S, Isler A. Validity and Reliability of the Seizure Self-Efficacy Scale for Children with Epilepsy. Noro Psikiyatr Ars. 2015 Mar;52(1):47-53. doi: 10.5152/npa.2015.7399. Epub 2015 Mar 1.
• Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
• Miles MS, Carlson J, Brunssen S. The nurse parent support tool. J Pediatr Nurs. 1999 Feb;14(1):44-50. doi: 10.1016/S0882-5963(99)80059-1.
• Caplin D, Austin JK, Dunn DW, Shen J, Perkins S. Development of a self-efficacy scale for children and adolescents with epilepsy. Children's Health Care. 2002; 31(4): 295-309.
• Ersun A, Bolışık B. VALIDITY AND RELIABILITY OF THE TURKISH ADAPTATION OF THE CHILD ATTITUDE TOWARD ILLNESS SCALE. EGEHFD. 2012; 28:37-45.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2021
• Primary Completion (Actual): November 11, 2021
• Study Completion (Actual): March 11, 2022

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Adolescent; Epilepsy; Self-Management; Education; Chronic Disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures
• Other Study ID Numbers: KaratayUh01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It will be shared after the article is published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No