- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04144478
Web-Based Epilepsy Education Program for Adolescents and Parents
Web-Based Epilepsy Education Program for Adolescents and Parents: A Randomized Controlled Trial
Study Overview
Detailed Description
This study aims to develop a web-based epilepsy education program for adolescents with epilepsy and their parents and to evaluate the efficacy of web-based epilepsy education program on health management.
This randomized controlled study was conducted with 69 adolescents with epilepsy aged between 9-18 and their parents (n=71) who were accepted to Pediatric Neurology Policlinic of Antalya Training and Research Hospital of Health Science University between November 2017 and April 2018. The study sample was divided into two groups as study (35 adolescents, 37 parents) and control (34 adolescents, 34 parents) groups using simple randomization method. The web-based epilepsy training program which was developed during the preparation stage of the study was evaluated by 13 experts using the Quality of Criteria for Consumer Health Information measurement instrument. The data collection materials (Seizure Self efficacy scale, E-Health literacy scale, Child Attitude Toward Illness Scale, Website Analysis and MeasureMent Inventory Scale) were administered by the researcher to the adolescents and parents in both groups before applying eb-based epilepsy education program. Following the administration of eb-based epilepsy education program to the initiative group, all participants were observed for three months. The data collection materials were reapplied to all the participants at the end of the third month. In addition, the adolescents and their parents in the study group were applied Website Analysis and Measurement Inventory measurement tool for the evaluation of usability of the site.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Isparta, Turkey, 32200
- Suleyman Demirel University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Adolescents and parents who do not use the Internet
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental
Web based education intervention
|
Web based education
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No Intervention: No intervention
Normal polyclinics application
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Epilepsy Knowledge Test
Time Frame: 12 week
|
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.
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12 week
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Seizure Self Efficacy Scale
Time Frame: 12 week
|
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
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Child Attitude Toward Ilness Scale
Time Frame: 12 week
|
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.
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12 week
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e-Health Literacy Scale
Time Frame: 12 week
|
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.
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12 week
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Website Analysis and MeasureMent Inventory
Time Frame: 12 week
|
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.
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12 week
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Quality of Criteria for Consumer Health Information
Time Frame: 12 week
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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.
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12 week
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Suleyman Demirel University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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