Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06194916 |
| Other study ID # |
AtaturkU-HMSRLK-SU-01 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2024 |
| Est. completion date |
September 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Ataturk University |
| Contact |
suheda üstündag |
| Phone |
05419281997 |
| Email |
ustundagsuheda[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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:
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.
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.
