Phenomenological Approach of Epilepsy in Patients With Epilepsy

NCT02952456 | Completed DMC

• 1 other identifier: UF9682
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

SUDEP; Epilepsy; Qualitative research; Risks associated with epilepsy; Epilepsy-related deaths

Outcome Measures

Primary Outcomes (1)

• interview with a psychologist

  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

  1 day

Study Arms (3)

Bereaved families

Person who have lost a loved one from an epilepsy-related death with interview with a psychologist

Other: interview with a psychologist

Patients with épilepsy

Patients with épilepsy with interview with a psychologist

Other: interview with a psychologist

Relatives of patients with epilepsy

Relatives (Parents / spouse/ Husband) of patients with epilepsy with interview with a psychologist

Other: interview with a psychologist

Interventions

interview with a psychologist OTHER

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

Bereaved families; Patients with épilepsy; Relatives of patients with epilepsy

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Université Montpellier: collaborator

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Epilepsy; Sudden Unexpected Death in Epilepsy

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GERALD BOURREL, MD PhD

  University of Montpellier

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 2, 2016
• Study Start: September 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2021
• Last Updated: August 11, 2022

Record last verified: 2022-08

Locations

FR (1)