NCT05671575

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

November 27, 2022

Last Update Submit

January 3, 2023

Conditions

Keywords

EpilepsyKnowledge and AttitudeQuality of life

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

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.

Eligibility Criteria

Age16 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university hospital

Sohag, 82611, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 26556558BACKGROUND
  • 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.

    PMID: 19838443BACKGROUND
  • 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.

    PMID: 29033636BACKGROUND
  • 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.

    PMID: 9700835BACKGROUND
  • 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.

    PMID: 16675306BACKGROUND

MeSH Terms

Conditions

EpilepsyBehavior

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Mohamed A Abdellah, resident

CONTACT

Hassan Mohamed Elnady, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
neuropsychiatry resident

Study Record Dates

First Submitted

November 27, 2022

First Posted

January 4, 2023

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

January 4, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations