Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phenomenological Approach of Epilepsy in Patients With Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02952456
Recruitment Status : Unknown
Verified October 2016 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : November 2, 2016
Last Update Posted : March 6, 2017
Sponsor:
Collaborator:
Université Montpellier
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

Rationale : Persons with epilepsy have a greater risk of incurring accidental injury and a higher mortality risk than the general population.

The main objective of the study is to understand life experience of the disease or risks associated with epilepsy in patients with epilepsy, relatives of patients and bereaved families.

Study design: Qualitative study (study based on interviews) Population: Three groups will be interviewed: bereaved families, patients with epilepsy and relatives of patient. Bereaved family: relatives who contact the French sentinel network "Réseau Sentinelle Mortalité Epilepsie" (RSME) notifying an epilepsy-related death (regardless the cause of the death and the timeframe between death and interview). Patients with epilepsy: patients having a secure diagnostic of epilepsy from 15 years old to 65 years old. Relatives of patients with epilepsy: spouse/husband or parents invited by a patient with epilepsy to participate to the interview who consent to participate.

Method: Semi structured in-depth interviews will be conducted by an experienced qualitative psychologist in face to face, at home, at the hospital or at any other place (depending on the choice of the participants). The interview topic guide will be centered on participants'personal experience. Interviews will be digitally recorded and will be transcribed by a secretary.

The results of this study will be integrated in educational therapeutic programs regarding prevention of risks related to epilepsy.


Condition or disease Intervention/treatment
Epilepsy Other: interview with a psychologist

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Phenomenological Approach of Epilepsy in Patients With Epilepsy and Their Relatives for Risk Prevention
Study Start Date : September 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Group/Cohort Intervention/treatment
Bereaved families
Person who have lost a loved one from an epilepsy-related death with interview with a psychologist
Other: interview with a psychologist
interview with a psychologist in Bereaved families, Patients with épilepsy and relatives of patients with epilepsy Relatives (Parents / spouse/ Husband) of patients with epilepsy

Patients with épilepsy
Patients with épilepsy with interview with a psychologist
Other: interview with a psychologist
interview with a psychologist in Bereaved families, Patients with épilepsy and relatives of patients with epilepsy Relatives (Parents / spouse/ Husband) of patients with epilepsy

Relatives of patients with epilepsy
Relatives (Parents / spouse/ Husband) of patients with epilepsy with interview with a psychologist
Other: interview with a psychologist
interview with a psychologist in Bereaved families, Patients with épilepsy and relatives of patients with epilepsy Relatives (Parents / spouse/ Husband) of patients with epilepsy




Primary Outcome Measures :
  1. interview with a psychologist [ Time Frame: 1 day ]

    The aim of this approach is to collect participants 'life-experiences in their own real and personal situation. Semistructured interviews with an in-depth questioning will be conducted by a psychologist The interview topic guide using open questions will be centered on participants' personal experience.

    The same topic guide will be used for the first group (epileptic patients) and the second group (relatives group). However, for the third group (bereaved families), the interview guide will be adapted, looking at life experience before death: focusing circumstances, particular events, behaviors or clinical signs which could give alarm.

    Interviews will be digitally recorded




Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The identification of bereaved families will be based on the French sentinel network "Réseau Sentinelle Mortalité Epilepsie". This network was initially established by the French League Against Epilepsy under the leadership of bereaved families in 2010 and supported by the French Foundation for Epilepsy Research . The primary aim of the RSME is to detail the causes and circumstances of epilepsy-related deaths in France. Secondary objectives are to evaluate the expectations and needs of bereaved families. Epilepsy-related deaths are reported by physicians but also by bereaved families. The interview will be proposed at this moment. Moreover the RSME includes a national network of bereaved families. The interview will be also proposed to the participants of this network.Patients with epilepsy and relatives of patients will be recruited from tertiary epilepsy units, private neurologists or general practitioners and thanks from patients associations.
Criteria

Inclusion Criteria:

  • Bereaved family: Parents or spouse/husband who contact the coordination unit of the RSME in order to notify an epilepsy related death and who consent for an interview regardless of the cause of death and timeframe between death and interview.
  • Patients with epilepsy: Patients having a secure diagnostic of epilepsy with active epilepsy (treated or not) or in remission under treatment or without treatment aged from 15 years to 65 years old.
  • Relatives of patients with epilepsy: Parents or spouse/husband invited by a patient with epilepsy to participate to the interview who consent to participate.

Exclusion Criteria:

  • Patients or relatives with learning difficulties
  • Refusal of participation of the patients or relatives or legal representatives for patients aged under 18 years old
  • Refusal for audio recording

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952456


Contacts
Layout table for location contacts
Contact: GERALD GB BOURREL, MD PhD 411757065 ext 33 g.bourrel@wanadoo.fr
Contact: Marie-Christine MP PICOT, MD PhD 467338978 ext 33 mc-picot@chu-montpellier.fr

Locations
Layout table for location information
France
Uhmontpellier Recruiting
Montpellier, France, 34295
Contact: GERARD BOURREL         
Sponsors and Collaborators
University Hospital, Montpellier
Université Montpellier
Investigators
Layout table for investigator information
Study Director: GERALD BOURREL, MD PhD University of Montpellier

Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02952456     History of Changes
Other Study ID Numbers: UF9682
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital, Montpellier:
SUDEP
Epilepsy
Qualitative research
Risks associated with epilepsy
Epilepsy-related deaths
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases