Clinical trial NCT04822662: 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
Overall status: COMPLETED
Phase: NA
Conditions: Self Management
Epilepsy; Seizure
Quality of Life
Keywords: Epilepsy
Self-Management
Chronic Disease
Adolescent
Education
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 36
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Child Introduction Form
timeFrame: First measurement - Before education programme (1st week)
measure: Development of the Child Attitude Toward Illness Scale
timeFrame: First measurement - Before education programme (1st week)
measure: Seizure Self-Efficacy Scale for Children
timeFrame: First measurement - Before education programme (1st week)
measure: The Children's Quality of Life Scale
timeFrame: First measurement - Before education programme (1st week)
measure: Parents Information Form
timeFrame: First measurement - Before education programme (1st week)
measure: Nurse-Parent Support Scale
timeFrame: First measurement - Before education programme (1st week)
Secondary outcomes:
measure: Development of the Child Attitude Toward Illness Scale
timeFrame: Second measurement - After education programme (10th week)
measure: Seizure Self-Efficacy Scale for Children
timeFrame: Second measurement - After education programme (10th week)
measure: The Children's Quality of Life Scale
timeFrame: Second measurement - After education programme (10th week)
measure: Nurse-Parent Support Scale
timeFrame: Second measurement - After education programme (10th week)
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
state: Meram
Study officials:
affiliation: KTO Karatay University
name: Hilal Kurt Sezer, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Selcuk University
name: Sibel KUCUKOGLU, Assoch prof
role: STUDY_DIRECTOR
affiliation: Necmettin Erbakan University
name: Abdullah Canbal, Dr
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
citation: Ersun A, Bolışık B. VALIDITY AND RELIABILITY OF THE TURKISH ADAPTATION OF THE CHILD ATTITUDE TOWARD ILLNESS SCALE. EGEHFD. 2012; 28:37-45.