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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05671575
Other study ID # Soh-Med-22-11-05
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2023
Est. completion date January 2024

Study information

Verified date January 2023
Source Sohag University
Contact Mohamed A Abdellah, resident
Phone 01003826960
Email mohamedadel@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 . 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date January 2024
Est. primary completion date January 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 110 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire about Epilepsy
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.

Locations

Country Name City State
Egypt Sohag university hospital Sohag

Sponsors (1)

Lead Sponsor Collaborator
Mohamed Adel Abdellah

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Bener 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. — View Citation

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. — View Citation

Mollaoglu 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. — View Citation

Ohaeri 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. — View Citation

Wheless 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year
Primary 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. 1 year
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