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

March 30, 2022 updated by: DILEK SAYIK

Randomized Controlled Study: Evaluation of the Efficiency of Mobile Application for Parents of Children With Epilepsy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Eskisehir
      • Odunpazari, Eskisehir, Turkey, 26080
        • Eskişehir City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: In application group; Mobile Epilepsy Training Program Impleme
  • 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

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.
No Intervention: In the control group

- 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the knowledge of the applicant group about epilepsy disease
Time Frame: 12 weeks

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
Time Frame: 12 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DILEK SAYIK

Investigators

  • Principal Investigator: DILEK SAYIK, PHD STUDENT, ESKİŞEHİR OSMANGAZİ UNIVERSITY INSTITUTE OF HEALTH SCIENCES

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2020

Primary Completion (Actual)

January 15, 2022

Study Completion (Actual)

January 15, 2022

Study Registration Dates

First Submitted

April 4, 2020

First Submitted That Met QC Criteria

April 9, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSAYIK
  • Ayfer AÇIKGÖZ (Other Identifier: ESKİŞEHİR OSMANGAZİ ÜNİVERSİTESİ)
  • Sevgi YİMENİCİOĞLU (Other Identifier: Eskısehir City Hospıtal)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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