AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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.

şuheda üstündağ contact

05419281997

ustundagsuheda@gmail.com

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:

  1. Individuals who agree to participate in the research
  2. Being over 18 years of age
  3. Having been diagnosed with epilepsy for at least 1 year
  4. Being able to use technological devices (phone, computer, tablet)
  5. Having internet access,
  6. Being able to speak Turkish,
  7. Not having any additional disease
  8. 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 groups in NCT06194916
Study groupRoleWhat they receive
education groupExperimentalA 4-week web-based self-management training will be administered to epilepsy patients in the experimental group.
Receives: Other: Education
Control GroupActive comparatorroutine interventions
Receives: Other: CONTROL GROUP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Personal Information Form Epilepsy Self-Management Scale

    Measured: pre-educationup to 4 weeks up to 8 weeks

Secondary outcomes (1)
  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.

  1. First posted8 Jan 2024
  2. Study startMar 2024 (estimated)
  3. Primary completionJun 2024 (estimated)
  4. Study completionSep 2024 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in