NCT04144478

Brief Summary

This study aims to develop a web-based epilepsy education program for adolescents with epilepsy and their parents and to evaluate the efficacy of eb-based epilepsy education program on health management.eb-based epilepsy education program has been proved to be a useful and reliable educational website for the development of knowledge, attitude, self-efficacy and e-health literacy of adolescents with epilepsy and their parents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

5 months

First QC Date

October 17, 2019

Last Update Submit

October 30, 2019

Conditions

Keywords

EpilepsyWeb based educationPediatric NursingParentAdolescence

Outcome Measures

Primary Outcomes (6)

  • Epilepsy Knowledge Test

    Epilepsy Knowledge test had applied pre-test and post-test. It consists of true (1), false (0) and I do not know (0) options. The minimum score to be taken from the scale is 0 and the maximum score is 25. The minimum score to be taken from the scale is 0 and the maximum score is 25. The increase in the total score indicates that the level of knowledge has increased.

    12 week

  • Seizure Self Efficacy Scale

    Seizure Self Efficacy Scale had applied pre-test and post-test. The scale is a 5-point likert with 15 items. It has been interpreterd that the higher the total score, the higher is the self-efficacy level of the individual. The minimum score to be taken from the scale is 15 and the maximum score is 75.

    12 week

  • Child Attitude Toward Ilness Scale

    Child Attitude Toward Ilness Scale had applied pre-test and post-test. The scale was a 5-point Likert type with 15 items. The minimum score to be taken from the scale is 15 and the maximum score is 75. 25. The minimum score to be taken from the scale is 0 and the maximum score is 25. The increase in the total score indicates that the child has positive attitude own illness.

    12 week

  • e-Health Literacy Scale

    e-Health Literacy Scale had applied pre-test and post-test. The lowest score that can be obtained from the 5-point Likert scale is 8 and the highest score is 40. A high score from the scale indicates a high level of e-health literacy.

    12 week

  • Website Analysis and MeasureMent Inventory

    Website Analysis and MeasureMent Inventory had applied both website under preparation and post test for control group.There are 5 dimensions that measure concepts like Attractiveness, Controllability, Efficiency, Helpfulness and Learnability. The total usability score is the weighted combination of expressions from each of the five sub-dimensions. The higher the scores obtained from the scale, the higher is the usability of the website and the more useful it is. The score obtained from the Website Analysis and MeasureMent Inventory is calculated in percentiles. the fact that each sub-dimension is above 50% means that its availability is high.

    12 week

  • Quality of Criteria for Consumer Health Information

    Quality of Criteria for Consumer Health Information scale is to be used in the assessment of the content and quality of educational material. Quality of Criteria for Consumer Health Information consists of 15 key questions plus an overall quality rating. The low total score indicates a poor quality and the high score indicates a good quality. The minimum score to be taken from the scale is 15 and the maximum score is 75.

    12 week

Study Arms (2)

experimental

EXPERIMENTAL

Web based education intervention

Other: Web based education

No intervention

NO INTERVENTION

Normal polyclinics application

Interventions

Web based education

experimental

Eligibility Criteria

Age12 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents without mental disability,
  • Followed-up for at least six months with epilepsy diagnosis,
  • No chronic disease other than epilepsy,
  • No photosensitive epilepsy diagnosis,
  • Internet access and use, and parents of these adolescents with internet access and use - were included in the study.

You may not qualify if:

  • Adolescents and parents who do not use the Internet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Süleyman Demirel University

Isparta, 32200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ayşegül İşler Dalgıç, Professor

    Akdeniz University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Nursing

Study Record Dates

First Submitted

October 17, 2019

First Posted

October 30, 2019

Study Start

November 1, 2017

Primary Completion

April 1, 2018

Study Completion

June 28, 2018

Last Updated

November 1, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will share

Research article

Shared Documents
CSR
Time Frame
2020-2021
Access Criteria
Open access

Locations