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Evaluation of the Efficiency of Mobile Application for Parents of Children With Epilepsy

Primary Purpose

Child, Epilepsy, Education

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
implementation of mobile epilepsy training program
Sponsored by
DILEK SAYIK
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Child focused on measuring Child, Epilepsy, Parental Education, Mobile Application, Pediatric Nurse

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Eskisehir City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

In application group; Mobile Epilepsy Training Program Impleme

In the control group

Arm Description

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.

- 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 4, 2020
Last Updated
March 30, 2022
Sponsor
DILEK SAYIK
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1. Study Identification

Unique Protocol Identification Number
NCT04343352
Brief Title
Evaluation of the Efficiency of Mobile Application for Parents of Children With Epilepsy
Official Title
Randomized Controlled Study: Evaluation of the Efficiency of Mobile Application for Parents of Children With Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 17, 2020 (Actual)
Primary Completion Date
January 15, 2022 (Actual)
Study Completion Date
January 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
DILEK SAYIK

4. Oversight

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

5. Study Description

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
Detailed Description
Chronic disease is defined as a condition that deviates from the normal, results from pathological changes and leaves permanent insufficiency, continues for a long time, and requires special training, long-term care and treatment for the patient's rehabilitation. Epilepsy, one of the chronic diseases, is one of the most common neurological disorders in childhood. The main goal in the treatment of epilepsy; It is based on the principle of ensuring seizure without harming the child's growth and development potential. In other words, controlling the seizures is to correctly identify the cause of the seizure and to help the child live a normal life. According to the National Institute for Health and Clinical Excellence, the role of the epilepsy specialist nurse in epilepsy management is not limited to seizure control, but requires multi-dimensional care planning. It is an important nursing role to regulate the lifestyle and increase the compliance with the treatment to increase the patients' non-seizure. At the same time, the key roles of the epilepsy nurse include continuing cooperation with other healthcare team members, collaborating with the public and epilepsy-related organizations, and providing necessary information and educational support to families and children. However, the support given to the family and the child is limited to the times that may come only with controls or for urgent reasons. Detailed solutions will be found to ensure the continuity of this support. Today, with the widespread use of the internet, healthcare education is increasing day by day. Web-based training applications prepared by professional experts are for information such as guidance, information and encouragement for patients with limited time and their parents. Participants phone contains at least one smartphone in almost every home in the internet age. there may be mobile applications to install. With the use of mobile applications in health care services, it is seen that the quality of life of the patients and their relatives and the quality of health care services increase, but also contributes economically to health institutions. The aim of the research is to develop and evaluate the effectiveness of the mobile epilepsy education program for parents with children diagnosed with epilepsy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child, Epilepsy, Education, Mobile Application, Nursing
Keywords
Child, Epilepsy, Parental Education, Mobile Application, Pediatric Nurse

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The research is a randomized controlled experimental study. Pretest - posttest with control and application group
Masking
None (Open Label)
Masking Description
Researchers and family will know about all the details of the study. Verbal and written permission will be obtained from families.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In application group; Mobile Epilepsy Training Program Impleme
Arm Type
Experimental
Arm Description
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.
Arm Title
In the control group
Arm Type
No Intervention
Arm Description
- 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.
Intervention Type
Other
Intervention Name(s)
implementation of mobile epilepsy training program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the knowledge of the applicant group about epilepsy disease
Description
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.
Time Frame
12 weeks
Title
Change in anxiety of the applicant group about epilepsy disease
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DILEK SAYIK, PHD STUDENT
Organizational Affiliation
ESKİŞEHİR OSMANGAZİ UNIVERSITY INSTITUTE OF HEALTH SCIENCES
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskisehir City Hospital
City
Odunpazari
State/Province
Eskisehir
ZIP/Postal Code
26080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
It will be shared after the study is finished (About 2 years later)
IPD Sharing 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.
Citations:
Citation
Fazlıoğlu, K., Hocaoğlu, Ç., & Sönmez F. M. Çocukluk Çağı Epilepsisinin Aileye Etkisi. Psikiyatride Güncel Yaklaşımlar, 2010; 2(2):189-205.
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PubMed Identifier
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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.
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Evaluation of the Efficiency of Mobile Application for Parents of Children With Epilepsy

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