NCT01374204

Brief Summary

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 .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

7.4 years

First QC Date

June 14, 2011

Last Update Submit

July 2, 2019

Conditions

Keywords

EpilepsyStigma

Outcome Measures

Primary Outcomes (1)

  • score of perceived stigma

    This scale estimates a score of perceived stigma for each individual and allows classifying individuals in 3 categories. Thus, 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. A positive response is characterized by threshold ≥ 1.

    Day one

Secondary Outcomes (2)

  • Evaluation of the illness experience will be performed by the first section of the EMIC.

  • Evaluation of the representations of epilepsy (perceived causes) will be done by the second section of the EMIC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a, descriptive and analytical study, based on a semi-directive interview among people suffering from epilepsy.

You may qualify if:

  • years and above
  • diagnosed by a neurologist as suffering from drug-resistant epilepsy (all types of seizures) outpatient in Neurology service of the investigation centres
  • inhabitant in the Limousin region
  • having signed the informed consent
  • affiliated or profiting of a social security system

You may not qualify if:

  • patients that are deprived of their freedom
  • patients with disabilities
  • patients suffering from a chronic or an acute delusional disorder
  • patients suffering from others handicaps

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de neurologie

Limoges, 87042, France

Location

MeSH Terms

Conditions

EpilepsySocial Stigma

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesSocial BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2011

First Posted

June 15, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations