EpilepsyNCT06194916
The Effect of Web-based Education Provided According to the Health Promotion Model on Self - Management in Epilepsy Patients
A study testing Education in people with Epilepsy, run by Ataturk University.
Trial summary
Epilepsy is a disease that requires long-term treatment and follow-up. Epilepsy To be successful in management, the educational needs of the patient must first be determined and the individual Treatment compliance should be increased by ensuring self-management of the disease.Interventions planned based on the model… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Sep 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who agree to participate in the research
- Being over 18 years of age
- Having been diagnosed with epilepsy for at least 1 year
- Being able to use technological devices (phone, computer, tablet)
- Having internet access,
- Being able to speak Turkish,
- Not having a psychiatric disease.
Who cannot join
- 1. Individuals who do not agree to participate in the research 2. Those under 18 years of age 3. Those with a psychiatric illness 4. Those who cannot use technological devices 5. Those who do not speak Turkish 6. Those diagnosed in less than 1 year
Trial locations and contacts
No sites are listed yet.
About this study
Epilepsy is a disease that requires long-term treatment and follow-up. Epilepsy To be successful in management, the educational needs of the patient must first be determined and the individual Treatment compliance should be increased by ensuring self-management of the disease.Interventions planned based on the model in patient education direct caregivers to specific goals and provide more planned, coordinated and safe care. The Health Promotion Model (HGM), developed by Nola Pender, is one of the models used to explain health protection and promotion behaviors. It is not aimed at preventing any disease or disability, but aims to improve health, in other words, to further increase the general health and well-being of the individual.
H0: Web-based education given to epilepsy patients according to the Health Promotion Model has no effect on self-management.
Read more
H1: Web-based education given to epilepsy patients according to the Health Promotion Model has an effect on self-management.
Research Inclusion Criteria:
- Individuals who agree to participate in the research
- Being over 18 years of age
- Having been diagnosed with epilepsy for at least 1 year
- Being able to use technological devices (phone, computer, tablet)
- Having internet access,
- Being able to speak Turkish,
- Not having any additional disease
- Being literate When starting the study, patients who apply to the outpatient clinic and meet the inclusion criteria will be given an explanation about the purpose of the research and how the research process will work. Then, written consent will be obtained indicating that they agree to participate in the study. Pretest data will be collected online. "Personal Information Form" and "Epilepsy Self-Management" scale will be used for individuals in the control and experimental groups to collect data.
In preparing the infrastructure of the web-based training program, a website called "Epilepsy Training Program" will be created with support from a professional computer engineering company. The training will include topics such as epilepsy, seizure management, medication management, safety management and lifestyle management. A training program consisting of presentations and videos will be offered on the website for a total of 4 weeks.
3 months after the training is completed, the "Epilepsy Self-Management Scale" will be applied to the experimental and control groups as a posttest.
Read the detailed description
Epilepsy; It is a chronic neurological disease characterized by epileptic seizures that occur as a result of abnormal and excessive electrical discharge in cortical neurons, develop suddenly, are repetitive, and are not triggered by an identifiable event. Epilepsy is a disease that requires long-term treatment and follow-up. To be successful in the management of epilepsy, the educational needs of the patient must first be determined and the individual's compliance with the treatment must be increased by ensuring self-management of the disease.
Patient education is supporting the patient's independence to meet his or her own health needs. In a randomized controlled study, within the scope of a modular epilepsy education program, patients were given; Information was given about the etiology, epidemiology, diagnosis, treatment options, self-control, life with epilepsy and psychosocial dimensions of epilepsy, and it was determined that there was a significant increase in coping with the disease of the patients included in the program. In a randomized controlled study conducted in Iran, when looking at the effect of self-management training given to epilepsy patients with low education levels on medication compliance, it was found that medication compliance was significantly higher in the trained group.
Interventions planned based on the model in patient education direct caregivers to specific goals and provide more planned, coordinated and safe care. The Health Promotion Model (HGM), developed by Nola Pender, is one of the models used to explain health protection and promotion behaviors. It is not aimed at preventing any disease or disability, but aims to improve health, in other words, to further increase the general health and well-being of the individual. It has been reported that training based on SGM in various chronic diseases is effective in improving health behaviors. In a study examining the effect of patient education based on SGM on breast and cervical cancer early detection behaviors, it was reported that patients developed positive behavioral changes after the training. Again, in a study conducted to standardize diabetes education, an epilepsy management model was created based on SGM.
When starting the study, patients who apply to the outpatient clinic and meet the inclusion criteria will be given an explanation about the purpose of the research and how the research process will work. Then, written consent will be obtained indicating that they agree to participate in the study. Pretest data will be collected online. "Personal Information Form" and "Epilepsy Self-Management" scale will be used for individuals in the control and experimental groups to collect data.
In preparing the infrastructure of the web-based training program, a website called "Epilepsy Training Program" will be created with support from a professional computer engineering company. The training will include topics such as epilepsy, seizure management, medication management, safety management and lifestyle management. A training program consisting of presentations and videos will be offered on the website for a total of 4 weeks.
3 months after the training is completed, the "Epilepsy Self-Management Scale" will be applied to the experimental and control groups as a posttest.
Data Collection Tools:
Personal Information Form: It was created by the researcher as a result of literature review. It includes introductory sociodemographic characteristics of the patients and questions about the disease.
Epilepsy Self-Management Scale: Developed by Dilorio et al. (2004). A Turkish validity and reliability study was conducted by Yeni (2014). The scale consists of 38 items; It has five subscales that evaluate medication (10 items), safety (8 items), information (8 items), lifestyle (6 items) and seizure (6 items) management in individuals with epilepsy. It is evaluated in a 5-point Likert format and is scored between 1-5. 38 points is the minimum score that can be obtained from the scale, 190 points is the maximum score, and high scores indicate that individuals frequently use self-management behaviors. The Cronbach Alpha reliability coefficient of the Epilepsy Self-Management Scale was found to be 0.740.
Evaluation of Data: Data will be analyzed with SPSS for Windows 17 package program. Score average, percentages, standard deviation, and other analyzes deemed appropriate will be used when analyzing the data.
- Conditions
- Epilepsy
- Being tested
- Education, CONTROL GROUP
- Keywords
- epilesy,education,self management
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
A 4-WEEK SELF-MANAGEMENT TRAINING WILL BE PROVIDED THROUGH THE WEB-BASED TRAINING SITE.
CONTROL GROUPOther
THEY WILL RECEIVE THE ROUTINE CARE GIVEN TO PATIENTS WITH EPILEPSY.
| Study group | Role | What they receive |
|---|---|---|
| education group | Experimental | A 4-week web-based self-management training will be administered to epilepsy patients in the experimental group. Receives: Other: Education |
| Control Group | Active comparator | routine interventions Receives: Other: CONTROL GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form Epilepsy Self-Management Scale
Measured: pre-educationup to 4 weeks up to 8 weeks
Secondary outcomes (1)
Epilepsy Self-Management Scale
Measured: 3 months after the education is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study startMar 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (estimated)
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.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ŞUHEDA ÜSTÜNDAĞ, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194916
- Sponsor's protocol ID
- AtaturkU-HMŞRLK-SU-01
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web-based Education Provided According to the Health Promotion Model on Self - Management in Epilepsy Patients
- ClinicalTrials.gov ID
- NCT06194916
- Acronym / sponsor ID
- AtaturkU-HMŞRLK-SU-01
- Conditions
- Epilepsy
- Keywords
- epilesy,education,self management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 8 Jan 2024 (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.
Epilepsy is a disease that requires long-term treatment and follow-up. Epilepsy To be successful in management, the educational needs of the patient must first be determined and the individual Treatment compliance should be increased by ensuring self-management of the disease.Interventions planned based on the model in patient education direct caregivers to specific goals and provide more planned, coordinated and safe care. The Health Promotion Model (HGM), developed by Nola Pender, is one of the models used to explain health protection and promotion behaviors. It is not aimed at preventing any disease or disability, but aims to improve health, in other words, to further increase the general health and well-being of the individual.
H0: Web-based education given to epilepsy patients according to the Health Promotion Model has no effect on self-management.
H1: Web-based education given to epilepsy patients according to the Health Promotion Model has an effect on self-management.
Research Inclusion Criteria:
- Individuals who agree to participate in the research
- Being over 18 years of age
- Having been diagnosed with epilepsy for at least 1 year
- Being able to use technological devices (phone, computer, tablet)
- Having internet access,
- Being able to speak Turkish,
- Not having any additional disease
- Being literate When starting the study, patients who apply to the outpatient clinic and meet the inclusion criteria will be given an explanation about the purpose of the research and how the research process will work. Then, written consent will be obtained indicating that they agree to participate in the study. Pretest data will be collected online. "Personal Information Form" and "Epilepsy Self-Management" scale will be used for individuals in the control and experimental groups to collect data.
In preparing the infrastructure of the web-based training program, a website called "Epilepsy Training Program" will be created with support from a professional computer engineering company. The training will include topics such as epilepsy, seizure management, medication management, safety management and lifestyle management. A training program consisting of presentations and videos will be offered on the website for a total of 4 weeks.
3 months after the training is completed, the "Epilepsy Self-Management Scale" will be applied to the experimental and control groups as a posttest.
Detailed description
Epilepsy; It is a chronic neurological disease characterized by epileptic seizures that occur as a result of abnormal and excessive electrical discharge in cortical neurons, develop suddenly, are repetitive, and are not triggered by an identifiable event. Epilepsy is a disease that requires long-term treatment and follow-up. To be successful in the management of epilepsy, the educational needs of the patient must first be determined and the individual's compliance with the treatment must be increased by ensuring self-management of the disease.
Patient education is supporting the patient's independence to meet his or her own health needs. In a randomized controlled study, within the scope of a modular epilepsy education program, patients were given; Information was given about the etiology, epidemiology, diagnosis, treatment options, self-control, life with epilepsy and psychosocial dimensions of epilepsy, and it was determined that there was a significant increase in coping with the disease of the patients included in the program. In a randomized controlled study conducted in Iran, when looking at the effect of self-management training given to epilepsy patients with low education levels on medication compliance, it was found that medication compliance was significantly higher in the trained group.
Interventions planned based on the model in patient education direct caregivers to specific goals and provide more planned, coordinated and safe care. The Health Promotion Model (HGM), developed by Nola Pender, is one of the models used to explain health protection and promotion behaviors. It is not aimed at preventing any disease or disability, but aims to improve health, in other words, to further increase the general health and well-being of the individual. It has been reported that training based on SGM in various chronic diseases is effective in improving health behaviors. In a study examining the effect of patient education based on SGM on breast and cervical cancer early detection behaviors, it was reported that patients developed positive behavioral changes after the training. Again, in a study conducted to standardize diabetes education, an epilepsy management model was created based on SGM.
When starting the study, patients who apply to the outpatient clinic and meet the inclusion criteria will be given an explanation about the purpose of the research and how the research process will work. Then, written consent will be obtained indicating that they agree to participate in the study. Pretest data will be collected online. "Personal Information Form" and "Epilepsy Self-Management" scale will be used for individuals in the control and experimental groups to collect data.
In preparing the infrastructure of the web-based training program, a website called "Epilepsy Training Program" will be created with support from a professional computer engineering company. The training will include topics such as epilepsy, seizure management, medication management, safety management and lifestyle management. A training program consisting of presentations and videos will be offered on the website for a total of 4 weeks.
3 months after the training is completed, the "Epilepsy Self-Management Scale" will be applied to the experimental and control groups as a posttest.
Data Collection Tools:
Personal Information Form: It was created by the researcher as a result of literature review. It includes introductory sociodemographic characteristics of the patients and questions about the disease.
Epilepsy Self-Management Scale: Developed by Dilorio et al. (2004). A Turkish validity and reliability study was conducted by Yeni (2014). The scale consists of 38 items; It has five subscales that evaluate medication (10 items), safety (8 items), information (8 items), lifestyle (6 items) and seizure (6 items) management in individuals with epilepsy. It is evaluated in a 5-point Likert format and is scored between 1-5. 38 points is the minimum score that can be obtained from the scale, 190 points is the maximum score, and high scores indicate that individuals frequently use self-management behaviors. The Cronbach Alpha reliability coefficient of the Epilepsy Self-Management Scale was found to be 0.740.
Evaluation of Data: Data will be analyzed with SPSS for Windows 17 package program. Score average, percentages, standard deviation, and other analyzes deemed appropriate will be used when analyzing the data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| education group | Experimental | Other: EducationA 4-week web-based self-management training will be administered to epilepsy patients in the experimental group. |
| Control Group | Active comparator | Other: CONTROL GROUProutine interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals who agree to participate in the research
- Being over 18 years of age
- Having been diagnosed with epilepsy for at least 1 year
- Being able to use technological devices (phone, computer, tablet)
- Having internet access,
Key exclusion criteria (1 listed)
- 1. Individuals who do not agree to participate in the research 2. Those under 18 years of age 3. Those with a psychiatric illness 4. Those who cannot use technological devices 5. Those who do not speak Turkish 6. Those diagnosed in less than 1 year
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 |
|---|---|---|
| EducationA 4-WEEK SELF-MANAGEMENT TRAINING WILL BE PROVIDED THROUGH THE WEB-BASED TRAINING SITE. | Other | education group |
| CONTROL GROUPTHEY WILL RECEIVE THE ROUTINE CARE GIVEN TO PATIENTS WITH EPILEPSY. | Other | Control Group |
Primary outcome
Personal Information Form Epilepsy Self-Management Scale
Time frame: pre-educationup to 4 weeks up to 8 weeks
1 secondary outcome
Epilepsy Self-Management Scale
Time frame: 3 months after the education is completed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: Yes
Related trials for Epilepsy
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Epilepsy, run by Ataturk University.
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 7 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: status not confirmed, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact şuheda üstündağ (05419281997, ustundagsuheda@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Information Form Epilepsy Self-Management Scale (time frame: pre-educationup to 4 weeks up to 8 weeks). 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 8 Jan 2024.