EpilepsyNCT05671575
Study The Knowledge and Attitude Towards Epilepsy Among Relatives of People With Epilepsy and Their Impact on The Patient's Quality of Life
An observational study of Epilepsy, run by Mohamed Adel Abdellah at 1 site in Egypt.
Trial summary
Epilepsy is a common neurological condition that affects personal and familial behavior and social support . About 50 million people worldwide suffer from epilepsy and the prevalence of active epilepsy in developing countries is 5 to 10 per 100 persons . Read more about this study
- Who is it for?
- Ages 16 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Questionnaire about Epilepsy
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2023to Jan 2024
- Phase
- Observational
- 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 16 to 110 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: participants Will be the close relatives of people with epilepsy who had a close relationship with the patient and living in the same house. The respondents will include the mothers, fathers, brothers, sisters, or the husband/wife, sons of patients. The patients will be patients diagnosed of epilepsy for at least 6 months, who were using antiepileptic drugs. The patients will be patients diagnosed of epilepsy for at least 6 months, who were using antiepileptic drugs.
Who may be able to join
- The participants Will be the close relatives of people with epilepsy who had a close relationship with the patient and living in the same house. The respondents will include the mothers, fathers, brothers, sisters, or the husband/wife, sons of patients.
- The patients will be patients diagnosed of epilepsy for at least 6 months, who were using antiepileptic drugs.
Who cannot join
- The Relatives not living in the same house or not in direct contact with the patients or younger than 16 years old will be excluded from the study.
- The persons who had major medical or mental health problems other than epilepsy that would affect QOL will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of The Knowledge and Attitude Towards Epilepsy Among Close Relatives of People With Epilepsy and Their Impact on The Patient's Quality of Life
Epilepsy is a common neurological condition that affects personal and familial behavior and social support . About 50 million people worldwide suffer from epilepsy and the prevalence of active epilepsy in developing countries is 5 to 10 per 100 persons . Individuals with epilepsy may suffer from psychological issues such as depression, anxiety, and psychosis . Accordingly, living with a person with epilepsy will provide some challenges, particularly at home. Studies have reported that relatives of people with epilepsy have an increased risk of anxiety. Epilepsy can inflict an enormous burden on both the people with epilepsy (PWE) and their family caregivers, decreasing their quality of life and daily efficiency.
- Conditions
- Epilepsy
- Being tested
- Questionnaire about Epilepsy
- Keywords
- Epilepsy, Knowledge and Attitude, Quality of life
- Medical subject headings
- Epilepsy, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire about EpilepsyOther
After obtaining informed consent, a structured questionnaire will be administered to the accompanying relative. The questionnaire consists of 5 sections: participants socio-demographic characteristics, patient demographic and clinical characteristics, participants knowledge about epilepsy including sources of knowledge and management of an acute seizure, general attitudes, and behaviors towards the People with epilepsy, Stigma scale of epilepsy.[14], and Quality of life in epilepsy-10 inventory (QOLIE-10) as the main data collection tool as regard quality of life of patients with epilepsy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge and attitudes toward epilepsy among close Relatives of people with Epilepsy.
This study will be conducted to assess the degree of knowledge and attitudes toward epilepsy among close Relatives of people with Epilepsy. A structured questionnaire will be administered to the accompanying relative. The questionnaire will assess this knowledge and the sources that close relatives obtain this knowledge from, including general attitude towards the People with epilepsy, and contains section that assess sigma about epilepsy using Stigma scale of epilepsy.
Measured: 1 year
Quality of life of people with epilepsy.
We will use the Quality of life in epilepsy-10 inventory (QOLIE-10) as the main collection tool as regard quality of life of people with epilepsy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Adel Abdellah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Adel Abdellah, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671575
- Sponsor's protocol ID
- Soh-Med-22-11-05
- Status last verified
- Jan 2023
- First submitted
- 27 Nov 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ekeh BC, Ekrikpo UE. The Knowledge, Attitude, and Perception towards Epilepsy amongst Medical Students in Uyo, Southern Nigeria. Adv Med. 2015;2015:876135. doi: 10.1155/2015/876135. Epub 2015 Mar 31.
PubMed 26556558Ohaeri JU, Awadalla AW, Farah AA. Quality of life in people with epilepsy and their family caregivers. An Arab experience using the short version of the World Health Organization quality of life instrument. Saudi Med J. 2009 Oct;30(10):1328-35.
PubMed 19838443Mollaoglu M, Mollaoglu M, Durna Z. Validity and Reliability of the Quality of Life in Epilepsy Inventory (QOLIE-10) For Turkey. Noro Psikiyatr Ars. 2017 Sep;54(3):239-243. doi: 10.5152/npa.2016.13809. Epub 2017 Jan 12.
PubMed 29033636Bener A, al-Marzooqi FH, Sztriha L. Public awareness and attitudes towards epilepsy in the United Arab Emirates. Seizure. 1998 Jun;7(3):219-22. doi: 10.1016/s1059-1311(98)80039-3.
PubMed 9700835Wheless JW. Intractable epilepsy: A survey of patients and caregivers. Epilepsy Behav. 2006 Jun;8(4):756-64. doi: 10.1016/j.yebeh.2006.03.010. Epub 2006 May 3.
PubMed 16675306
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of The Knowledge and Attitude Towards Epilepsy Among Close Relatives of People With Epilepsy and Their Impact on The Patient's Quality of Life
- ClinicalTrials.gov ID
- NCT05671575
- Acronym / sponsor ID
- Soh-Med-22-11-05
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Knowledge and Attitude, Quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mohamed Adel AbdellahUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 4 Jan 2023 (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 common neurological condition that affects personal and familial behavior and social support . About 50 million people worldwide suffer from epilepsy and the prevalence of active epilepsy in developing countries is 5 to 10 per 100 persons . Individuals with epilepsy may suffer from psychological issues such as depression, anxiety, and psychosis . Accordingly, living with a person with epilepsy will provide some challenges, particularly at home. Studies have reported that relatives of people with epilepsy have an increased risk of anxiety. Epilepsy can inflict an enormous burden on both the people with epilepsy (PWE) and their family caregivers, decreasing their quality of life and daily efficiency.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- participants Will be the close relatives of people with epilepsy who had a close relationship with the patient and living in the same house. The respondents will include the mothers, fathers, brothers, sisters, or the husband/wife, sons of patients. The patients will be patients diagnosed of epilepsy for at least 6 months, who were using antiepileptic drugs. The patients will be patients diagnosed of epilepsy for at least 6 months, who were using antiepileptic drugs.
Key inclusion criteria (2 listed)
- The participants Will be the close relatives of people with epilepsy who had a close relationship with the patient and living in the same house. The respondents will include the mothers, fathers, brothers, sisters, or the husband/wife, sons of patients.
- The patients will be patients diagnosed of epilepsy for at least 6 months, who were using antiepileptic drugs.
Key exclusion criteria (2 listed)
- The Relatives not living in the same house or not in direct contact with the patients or younger than 16 years old will be excluded from the study.
- The persons who had major medical or mental health problems other than epilepsy that would affect QOL will be excluded.
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 |
|---|---|---|
| Questionnaire about EpilepsyAfter obtaining informed consent, a structured questionnaire will be administered to the accompanying relative. The questionnaire consists of 5 sections: participants socio-demographic characteristics, patient demographic and clinical characteristics, participants knowledge about epilepsy including sources of knowledge and management of an acute seizure, general attitudes, and behaviors towards the People with epilepsy, Stigma scale of epilepsy.[14], and Quality of life in epilepsy-10 inventory (QOLIE-10) as the main data collection tool as regard quality of life of patients with epilepsy. | Other | – |
Primary outcome
Knowledge and attitudes toward epilepsy among close Relatives of people with Epilepsy.
Time frame: 1 year
This study will be conducted to assess the degree of knowledge and attitudes toward epilepsy among close Relatives of people with Epilepsy. A structured questionnaire will be administered to the accompanying relative. The questionnaire will assess this knowledge and the sources that close relatives obtain this knowledge from, including general attitude towards the People with epilepsy, and contains section that assess sigma about epilepsy using Stigma scale of epilepsy.
Quality of life of people with epilepsy.
Time frame: 1 year
We will use the Quality of life in epilepsy-10 inventory (QOLIE-10) as the main collection tool as regard quality of life of people with epilepsy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Background: PubMed 26556558Ekeh BC, Ekrikpo UE. The Knowledge, Attitude, and Perception towards Epilepsy amongst Medical Students in Uyo, Southern Nigeria. Adv Med. 2015;2015:876135. doi: 10.1155/2015/876135. Epub 2015 Mar 31.
- Background: PubMed 19838443Ohaeri JU, Awadalla AW, Farah AA. Quality of life in people with epilepsy and their family caregivers. An Arab experience using the short version of the World Health Organization quality of life instrument. Saudi Med J. 2009 Oct;30(10):1328-35.
- Background: PubMed 29033636Mollaoglu M, Mollaoglu M, Durna Z. Validity and Reliability of the Quality of Life in Epilepsy Inventory (QOLIE-10) For Turkey. Noro Psikiyatr Ars. 2017 Sep;54(3):239-243. doi: 10.5152/npa.2016.13809. Epub 2017 Jan 12.
- Background: PubMed 9700835Bener A, al-Marzooqi FH, Sztriha L. Public awareness and attitudes towards epilepsy in the United Arab Emirates. Seizure. 1998 Jun;7(3):219-22. doi: 10.1016/s1059-1311(98)80039-3.
- Background: PubMed 16675306Wheless JW. Intractable epilepsy: A survey of patients and caregivers. Epilepsy Behav. 2006 Jun;8(4):756-64. doi: 10.1016/j.yebeh.2006.03.010. Epub 2006 May 3.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Mohamed Adel Abdellah at 1 site in Egypt.
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 2 inclusion and 2 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 4 Jan 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A Abdellah, resident (01003826960, mohamedadel@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge and attitudes toward epilepsy among close Relatives of people with Epilepsy. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05671575, which also lists 5 linked publications.
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 4 Jan 2023.