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

NCT04822662 | Completed

• 1 other identifier: KaratayUh01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Self Management; Epilepsy; Seizure; Quality of Life

Keywords

Epilepsy; Self-Management; Chronic Disease; Adolescent; Education

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Development of the Child Attitude Toward Illness Scale

  Second measurement - After education programme (10th week)

• Seizure Self-Efficacy Scale for Children

  Second measurement - After education programme (10th week)

• The Children's Quality of Life Scale

  Second measurement - After education programme (10th week)

• Nurse-Parent Support Scale

  Second measurement - After education programme (10th week)

Study Arms (2)

Experimental Group: Epilepsy education program

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Epilepsy Education Programme BEHAVIORAL

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.

Experimental Group: Epilepsy education program

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, 42090, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 8410570 RESULT

• 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.

  PMID: 28360675 RESULT

• 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.

  PMID: 11468499 RESULT

• 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.

  PMID: 10063248 RESULT

• 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.

  RESULT

• Ersun A, Bolışık B. VALIDITY AND RELIABILITY OF THE TURKISH ADAPTATION OF THE CHILD ATTITUDE TOWARD ILLNESS SCALE. EGEHFD. 2012; 28:37-45.

  RESULT

• Sezer HK, Kucukoglu S, Canbal A. The effectiveness of an individual and family self-management theory-based education program given for adolescents with epilepsy and parents: Randomized controlled trial. J Pediatr Nurs. 2024 Nov-Dec;79:171-180. doi: 10.1016/j.pedn.2024.08.026. Epub 2024 Sep 13.

  PMID: 39276443 DERIVED

MeSH Terms

Conditions

Epilepsy; Chronic Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hilal Kurt Sezer, Master

  KTO Karatay University

  PRINCIPAL INVESTIGATOR

• Sibel KUCUKOGLU, Assoch prof

  Selcuk University

  STUDY DIRECTOR

• Abdullah Canbal, Dr

  Necmettin Erbakan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blinded (Participant, Outcomes Assessor)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 30, 2021
• Study Start: March 11, 2021
• Primary Completion: November 11, 2021
• Study Completion: March 11, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)