Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2026-01-01 @ 2:48 PM
Study NCT ID:
NCT01374204
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2011-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epilepsy-Associated Stigma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D057545', 'term': 'Social Stigma'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-02', 'studyFirstSubmitDate': '2011-06-14', 'studyFirstSubmitQcDate': '2011-06-14', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'score of perceived stigma', 'timeFrame': 'Day one', 'description': 'This scale estimates a score of perceived stigma for each individual and allows classifying individuals in 3 categories.\n\nThus, individuals who obtain a total score of 0 will be those who do not feel stigmatized. Those whose scores will be over or equal to 1will be those who feel stigmatized. Finally, respondents whose the score is equal to 3 will be considered as having a strong perception of stigma.\n\nA positive response is characterized by threshold ≥ 1.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the illness experience will be performed by the first section of the EMIC.'}, {'measure': 'Evaluation of the representations of epilepsy (perceived causes) will be done by the second section of the EMIC'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epilepsy', 'Stigma'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'Few data about epilepsy-associated stigma in France are available. The only study we have found showed that in France 66% of people with epilepsy felt stigmatized by their condition and are often single, compared with the other European patients interviewed (Baker et al., 2000). The purpose of this study is to assess the association between type of epilepsy (drug resistant-epilepsy and stabilized epilepsy) and perceived stigma (using the Stigma Scale) in patients recruited in the Limousin region .', 'detailedDescription': 'Epilepsy-associated stigma leads important problems in terms of public health because it can provoke significant cognitive repercussions, impairment of quality of life and it causes physical injuries and serious disabilities. These social consequences often cause more suffering for patients than seizures themselves.\n\nThis heavy medical and social burden is associated with significant economic cost in terms of care and disability. It is also noted that mortality rate is 2 to 10 times higher than the general population.\n\nIt is therefore urgent to consider both medical and social dimension of consequences of epilepsy especially in patients with uncontrolled seizures.\n\nIt is also essential to detect a potential psychiatric disorder associated with epilepsy, especially depression and anxiety which are the most prevalent psychiatric comorbidities. These disorders are often under-diagnosed that can frequently leads to an inappropriate care.\n\nThe purpose of this study is to assess the association between type of epilepsy (drug resistant-epilepsy and stabilized epilepsy) and perceived stigma (using the Stigma Scale) in patients recruited in the Limousin region .\n\nThe primary outcome will be the score of perceived stigma obtained from the Stigma Scale.\n\nThis scale estimates a score of perceived stigma for each individual and allows classifying individuals in 3 categories.\n\nThus, individuals who obtain a total score of 0 will be those who do not feel stigmatized. Those whose scores will be over or equal to 1will be those who feel stigmatized. Finally, respondents whose the score is equal to 3 will be considered as having a strong perception of stigma.\n\nA positive response is characterized by threshold ≥ 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a, descriptive and analytical study, based on a semi-directive interview among people suffering from epilepsy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and above\n* diagnosed by a neurologist as suffering from drug-resistant epilepsy (all types of seizures) outpatient in Neurology service of the investigation centres\n* inhabitant in the Limousin region\n* having signed the informed consent\n* affiliated or profiting of a social security system\n\nExclusion Criteria:\n\n* patients that are deprived of their freedom\n* patients with disabilities\n* patients suffering from a chronic or an acute delusional disorder\n* patients suffering from others handicaps'}, 'identificationModule': {'nctId': 'NCT01374204', 'acronym': 'EPISTIGMA', 'briefTitle': 'Epilepsy-Associated Stigma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'EPILEPSY-ASSOCIATED STIGMA AND ILLNESS EXPERIENCE IN PEOPLE WITH EPILEPSY', 'orgStudyIdInfo': {'id': 'I09004'}}, 'contactsLocationsModule': {'locations': [{'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Service de neurologie', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}