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

Primary Purpose

Self Management, Epilepsy; Seizure, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Epilepsy Education Programme
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Self Management focused on measuring Epilepsy, Self-Management, Chronic Disease, Adolescent, Education

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Necmettin Erbakan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group: Epilepsy education program

Control Group

Arm Description

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.

The control group will receive standard epilepsy treatment without any training intervention. The group did not receive any other intervention.

Outcomes

Primary Outcome Measures

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).
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.
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.
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.
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.
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".

Secondary Outcome Measures

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.
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.
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.
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".

Full Information

First Posted
March 25, 2021
Last Updated
March 29, 2022
Sponsor
KTO Karatay University
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1. Study Identification

Unique Protocol Identification Number
NCT04822662
Brief Title
The Individual and Family Self Management Theory Based Epilepsy Education Program's Effectiveness
Official Title
The Effectiveness of The Education Program Based on The Individual and Family Self Management Theory Given For Epilepsy Adolescents and Parents: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
November 11, 2021 (Actual)
Study Completion Date
March 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KTO Karatay University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self Management, Epilepsy; Seizure, Quality of Life
Keywords
Epilepsy, Self-Management, Chronic Disease, Adolescent, Education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In this study, stratified sampling was employed based on age and sex. Two strata, [12-14 age, girl] and [15-18 age, boy], were generated to ensure even distribution in terms of age and sex in each group. First, thirty-six adolescent were stratified into two groups (A and B), which were then stratified again into two: [12-14 age, girl] and [15-18 age, boy]. A scheme was developed to randomize the age and sex of [12-14, girl] and [15-18 age, boy] into two groups (A and B), resulting in the experimental and control groups stratified by the age and sex and blocked into paired-groups of (2:2/[12-14 age, girl]:[15-18 age, boy]). Permutation was also used to strike a balance between the strata. Block sets were generated for each combination of the prognostic factors (age and sex). The experimental and control groups were then randomized into the strata using a random numbers table.
Masking
Participant
Masking Description
Single Blinded (Participant, Outcomes Assessor)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group: Epilepsy education program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will receive standard epilepsy treatment without any training intervention. The group did not receive any other intervention.
Intervention Type
Behavioral
Intervention Name(s)
Epilepsy Education Programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child Introduction Form
Description
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).
Time Frame
First measurement - Before education programme (1st week)
Title
Development of the Child Attitude Toward Illness Scale
Description
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.
Time Frame
First measurement - Before education programme (1st week)
Title
Seizure Self-Efficacy Scale for Children
Description
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.
Time Frame
First measurement - Before education programme (1st week)
Title
The Children's Quality of Life Scale
Description
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.
Time Frame
First measurement - Before education programme (1st week)
Title
Parents Information Form
Description
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.
Time Frame
First measurement - Before education programme (1st week)
Title
Nurse-Parent Support Scale
Description
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".
Time Frame
First measurement - Before education programme (1st week)
Secondary Outcome Measure Information:
Title
Development of the Child Attitude Toward Illness Scale
Description
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.
Time Frame
Second measurement - After education programme (10th week)
Title
Seizure Self-Efficacy Scale for Children
Description
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.
Time Frame
Second measurement - After education programme (10th week)
Title
The Children's Quality of Life Scale
Description
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.
Time Frame
Second measurement - After education programme (10th week)
Title
Nurse-Parent Support Scale
Description
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".
Time Frame
Second measurement - After education programme (10th week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilal Kurt Sezer, Master
Organizational Affiliation
KTO Karatay University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sibel KUCUKOGLU, Assoch prof
Organizational Affiliation
Selcuk University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abdullah Canbal, Dr
Organizational Affiliation
Necmettin Erbakan University
Official's Role
Study Director
Facility Information:
Facility Name
Necmettin Erbakan University
City
Konya
State/Province
Meram
ZIP/Postal Code
42090
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It will be shared after the article is published.
Citations:
PubMed Identifier
8410570
Citation
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.
Results Reference
result
PubMed Identifier
28360675
Citation
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.
Results Reference
result
PubMed Identifier
11468499
Citation
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.
Results Reference
result
PubMed Identifier
10063248
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
Ersun A, Bolışık B. VALIDITY AND RELIABILITY OF THE TURKISH ADAPTATION OF THE CHILD ATTITUDE TOWARD ILLNESS SCALE. EGEHFD. 2012; 28:37-45.
Results Reference
result

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

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