NCT04343352

Brief Summary

Introduction: support to family and child related to epilepsy, controls or when they come for urgent reasons. Solutions must be found to ensure its continuity. this support. The widespread use of the Internet today, e-health and health education is increasing day by day. Objective: The investigators research is planned to develop a mobile Epilepsy Training Program. Parents with children diagnosed with epilepsy and assessing its effectiveness. Material and Method: The research is a randomized controlled experimental study. An application was made to the Eskişehir Osmangazi University Clinical Research Ethics Committee and the ethics committee permission was obtained with the decision of 13.02.2020 dated 80558721-050.99-E.20230 and 2019-66 decision. Only volunteer participants will be included in the research. Its population study 3-6 years old children diagnosed with epilepsy Eskişehir City Hospital Child Neurology Outpatient Clinic between 01 September 2020 and 31 September 2021. The sample of the research will consist of parents who meet the inclusion criteria. research between these dates. Parents meeting research sample selection criteria The application was randomized as a control group according to the Parent Epilepsy Information Scale. Application group; will use the mobile application the investigators prepared for the parent. Control group will consist of parents who follow the hospital's treatment protocol. The investigators study Completed with a total of 60 parents, 30 of whom are determined by power analysis group. Statistical analysis will be done with SPSS package program. Keywords: Child, Epilepsy, Parent Education, Mobile Application, Child Nurse

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

October 17, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

April 4, 2020

Last Update Submit

March 30, 2022

Conditions

Keywords

ChildEpilepsyParental EducationMobile ApplicationPediatric Nurse

Outcome Measures

Primary Outcomes (2)

  • Change in the knowledge of the applicant group about epilepsy disease

    Change in the knowledge of the application group about epilepsy disease assessed with the Parent Epilepsy Information Scale "Parent Epilepsy Information Scale" will be filled in before and after the study (after 3 months) with the researcher, in order to measure the level of knowledge of parents about epilepsy. The high total score indicates that families have a high level of knowledge. Parents in the application group are expected to have an increased knowledge of epilepsy.

    12 weeks

  • Change in anxiety of the applicant group about epilepsy disease

    Change in anxiety level about epilepsy disease assessed with the The Parental Anxiety Scale for Seizures "The Parental Anxiety Scale for Seizures" will be filled with the face-to-face interview technique before and after the study (after 3 months) to determine the anxiety of the families of children with seizures. It is interpreted as the parental anxiety decreases as the score obtained from the scale increases. Anxiety levels of parents in the application group are expected to decrease.

    12 weeks

Study Arms (2)

In application group; Mobile Epilepsy Training Program Impleme

EXPERIMENTAL

* Mobile epilepsy training program will be introduced to the parents in the application group and pre-tests (Parent Epilepsy Knowledge Scale for Parents and Parental Anxiety Scale for Seizures Scale). * The participants will only use the mobile epilepsy training program application. * Parents in the application group will be monitored for 3 months using the mobile epilepsy training program. The researcher will follow the participants' use of the mobile application with the interface of the mobile epilepsy training program. During the monitoring phase, the Epilepsy Information Questions screen will be given once every 15 days, and the training module will be reopened automatically on missing or incorrect answers and the parent's information on this subject will be renewed. \- At the end of the 3rd month, posttests (Parent Epilepsy Knowledge Scale for Parents and Parental Anxiety Scale for Seizures Scale) will be applied face-to-face.

Other: implementation of mobile epilepsy training program

In the control group

NO INTERVENTION

\- The purpose of the project will be shared with the parents in the control group, and the pre-tests Parent Epilepsy Knowledge Scale for Parents and Parental Anxiety Scale for Seizures Scale). will be applied. There is no structured training program in the outpatient functioning. Routine practice of the hospital; is the education and information provided by the physician to the family during the outpatient clinic. * At the end of the 3rd month, the final tests (Parent Epilepsy Knowledge Scale for Parents and Parental Anxiety Scale for Seizures Scale). will be applied face to face. * After the work is completed, the mobile application will be installed on the phones of the control group, the application will be taught and applied.

Interventions

Mobile epilepsy training program will be applied to the application group for 3 months. The mobile epilepsy training program developed within the scope of the thesis will be introduced to the parents in the application group and the participants will be uploaded to their phones via computer, and the use of the program will be taught in practice. In addition, the participants in the application group will be informed that the mobile epilepsy training program is not open to everyone during the research process, only the application group can use it. After the work is completed, the mobile application control group will be installed on the phones of the parents via computer, their application will be taught and applied.

In application group; Mobile Epilepsy Training Program Impleme

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Can use and use Android based smart phone,
  • Literate,
  • Volunteers to participate in the study,
  • Does not have any other chronic disease other than epilepsy,
  • Parents with a child aged 3-6 years who are diagnosed with epilepsy at least six months ago (Tutar Güven, 2018) will be included in the study.

You may not qualify if:

  • without an Android-based smartphone,
  • IOS phone,
  • Not capable of using mobile applications,
  • Mentally disabled child
  • Hearing impaired and do not speak Turkish
  • Parents who are not willing to participate in the study will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskisehir City Hospital

Odunpazari, Eskişehir, 26080, Turkey (Türkiye)

Location

Related Publications (12)

  • Fazlıoğlu, K., Hocaoğlu, Ç., & Sönmez F. M. Çocukluk Çağı Epilepsisinin Aileye Etkisi. Psikiyatride Güncel Yaklaşımlar, 2010; 2(2):189-205.

    BACKGROUND
  • Çavuşoğlu, H. Çocuk sağlığı hemşireliği, 10. Baskı. Ankara: Sistem Ofset Basımevi. 2011; 330-348.

    BACKGROUND
  • Dennis TA, O'Toole L. Mental Health on the Go: Effects of a Gamified Attention Bias Modification Mobile Application in Trait Anxious Adults. Clin Psychol Sci. 2014 Sep 1;2(5):576-590. doi: 10.1177/2167702614522228.

    PMID: 26029490BACKGROUND
  • Falco-Walter JJ, Scheffer IE, Fisher RS. The new definition and classification of seizures and epilepsy. Epilepsy Res. 2018 Jan;139:73-79. doi: 10.1016/j.eplepsyres.2017.11.015. Epub 2017 Nov 28.

    PMID: 29197668BACKGROUND
  • O'Conner-Von S. Coping with cancer: a Web-based educational program for early and middle adolescents. J Pediatr Oncol Nurs. 2009 Jul-Aug;26(4):230-41. doi: 10.1177/1043454209334417. Epub 2009 May 15.

    PMID: 19448133BACKGROUND
  • Mo PK, Coulson NS. Developing a model for online support group use, empowering processes and psychosocial outcomes for individuals living with HIV/AIDS. Psychol Health. 2012;27(4):445-59. doi: 10.1080/08870446.2011.592981. Epub 2011 Aug 19.

    PMID: 21854088BACKGROUND
  • National Institue for Health and Clinical Excellence. (2004). The diagnosis and management of the epilepsis in adults and children in primary and secondary care, NICE. Available from: http://www.nice.org.uk/nicemedia/pdf/CG020NICEguideline.pdf Access Date: 01.07.2019.

    BACKGROUND
  • Rodenburg R, Marie Meijer A, Dekovic M, Aldenkamp AP. Family predictors of psychopathology in children with epilepsy. Epilepsia. 2006 Mar;47(3):601-14. doi: 10.1111/j.1528-1167.2006.00475.x.

    PMID: 16529629BACKGROUND
  • Scheffer IE, Berkovic S, Capovilla G, Connolly MB, French J, Guilhoto L, Hirsch E, Jain S, Mathern GW, Moshe SL, Nordli DR, Perucca E, Tomson T, Wiebe S, Zhang YH, Zuberi SM. ILAE classification of the epilepsies: Position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):512-521. doi: 10.1111/epi.13709. Epub 2017 Mar 8.

    PMID: 28276062BACKGROUND
  • Zararsız, M. (2009). Epilepside güvenliğin sağlanmasına ilişkin çocuğa ve ebeveynlere verilen eğitimin etkinliğinin değerlendirilmesi, Yüksek Lisans Tezi, Mersin Üniversitesi Sağlık Bilimleri Enstitüsü, Mersin

    BACKGROUND
  • Wohlrab GC, Rinnert S, Bettendorf U, Fischbach H, Heinen G, Klein P, Kluger G, Jacob K, Rahn D, Winter R, Pfafflin M; Famoses Project Group. famoses: a modular educational program for children with epilepsy and their parents. Epilepsy Behav. 2007 Feb;10(1):44-8. doi: 10.1016/j.yebeh.2006.10.005. Epub 2006 Nov 27.

    PMID: 17126082BACKGROUND
  • Tutar Güven, Ş. Ergen ve ebeveynlerine yönelik geliştirilen web tabanlı epilepsi eğitim programının etkinliğinin değerlendirilmesi, Doktora Tezi, Akdeniz Üniversitesi Sağlık Bilimleri Enstitüsü, Antalya. 2018

    BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • DILEK SAYIK, PHD STUDENT

    ESKİŞEHİR OSMANGAZİ UNIVERSITY INSTITUTE OF HEALTH SCIENCES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Researchers and family will know about all the details of the study. Verbal and written permission will be obtained from families.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The research is a randomized controlled experimental study. Pretest - posttest with control and application group
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 4, 2020

First Posted

April 13, 2020

Study Start

October 17, 2020

Primary Completion

January 15, 2022

Study Completion

January 15, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

With the mobile application, patients diagnosed with epilepsy and their parents / caregivers will be able to easily learn the correct information about epilepsy disease at any time (7/24) in any environment with a structured training program. Thanks to the mobile application, it will be possible to facilitate the compliance of diagnosis, follow-up and treatment in epilepsy disease. It is thought that mobile application will take place in child intensive care, child neurology and child clinics especially in the smartphones of children / parents / caregivers with epilepsy.

Shared Documents
STUDY PROTOCOL
Time Frame
It will be shared after the study is finished (About 2 years later)
Access Criteria
It will be shared with child / parent / caregivers with epilepsy and child intensive care, child neurology and healthcare professionals working in child clinics.

Locations