EpilepsyNCT04144478
Web-Based Epilepsy Education Program for Adolescents and Parents
A study testing Web based education in people with Epilepsy, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Web based education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 28 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Adolescents and parents who do not use the Internet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Web-Based Epilepsy Education Program for Adolescents and Parents: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Web based education
- Keywords
- Epilepsy, Web based education, Pediatric Nursing, Parent, Adolescence
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web based educationOther
Web based education
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Web based education intervention Receives: Other: Web based education |
| No intervention | No intervention | Normal polyclinics application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Nov 2017
- Primary completion1 Apr 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şerife TUTAR GÜVEN, Suleyman Demirel University
- Investigators
- Ayşegül İşler Dalgıç, Professor, Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144478
- Sponsor's protocol ID
- Suleyman Demirel University
- Status last verified
- Oct 2019
- First submitted
- 17 Oct 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research article
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-Based Epilepsy Education Program for Adolescents and Parents: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04144478
- Acronym / sponsor ID
- Suleyman Demirel University
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Web based education, Pediatric Nursing, Parent, Adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: Web based educationWeb based education intervention |
| No intervention | No intervention | –Normal polyclinics application |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Adolescents and parents who do not use the Internet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web based educationWeb based education | Other | experimental |
Primary outcome
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.
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.
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.
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.
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.
Quality of Criteria for Consumer Health Information
Time frame: 12 week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Individual participant dataSharing planned: Yes. Research article
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşegül İşler Dalgıç, Professor study director
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web based education in people with Epilepsy, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epilepsy Knowledge Test (time frame: 12 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.