EpilepsyEPISTIGMANCT01374204
Epilepsy-Associated Stigma
An observational study of Epilepsy, run by University Hospital, Limoges at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a, descriptive and analytical study, based on a semi-directive interview among people suffering from epilepsy.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EPILEPSY-ASSOCIATED STIGMA AND ILLNESS EXPERIENCE IN PEOPLE WITH EPILEPSY
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 .
Read the 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.
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Stigma
- Medical subject headings
- Epilepsy, Social Stigma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2018
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374204
- Sponsor's protocol ID
- I09004
- Acronym
- EPISTIGMA
- Status last verified
- Jul 2019
- First submitted
- 14 Jun 2011
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPILEPSY-ASSOCIATED STIGMA AND ILLNESS EXPERIENCE IN PEOPLE WITH EPILEPSY
- ClinicalTrials.gov ID
- NCT01374204
- Acronym / sponsor ID
- EPISTIGMA / I09004
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Stigma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 15 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a, descriptive and analytical study, based on a semi-directive interview among people suffering from epilepsy.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
score of perceived stigma
Time frame: Day one
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.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score of perceived stigma (time frame: Day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.