Epilepsy-Associated Stigma (EPISTIGMA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01374204
First received: June 14, 2011
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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 .


Condition
Epilepsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: EPILEPSY-ASSOCIATED STIGMA AND ILLNESS EXPERIENCE IN PEOPLE WITH EPILEPSY

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • score of perceived stigma [ Time Frame: Day one ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Evaluation of the illness experience will be performed by the first section of the EMIC. [ Designated as safety issue: No ]
  • Evaluation of the representations of epilepsy (perceived causes) will be done by the second section of the EMIC [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed Description:

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.

This 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.

It is therefore urgent to consider both medical and social dimension of consequences of epilepsy especially in patients with uncontrolled seizures.

It 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.

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 .

The primary outcome will be the score of perceived stigma obtained from the Stigma Scale.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374204

Locations
France
Service de neurologie
Limoges, France, 87042
Sponsors and Collaborators
University Hospital, Limoges
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01374204     History of Changes
Other Study ID Numbers: I09004
Study First Received: June 14, 2011
Last Updated: July 14, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Limoges:
Epilepsy
Stigma

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 01, 2014