Clinical trial NCT06877403: Prevalence and Impact of Fatigue in Myasthenic Patients Followed At Clermont-Ferrand University Hospital - "My" Asthenia
Official title: Prospective Study on the Prevalence and Impact of Fatigue in Myasthenic Patients Followed At Clermont-Ferrand University Hospital - "My" Asthenia
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Myasthenia Gravis
Keywords: observationnal
fatigue
self-questionnaires
myasthenia gravis
ocular myasthenia gravis
generalized myasthenia gravis
comorbidities
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Myasthenic patients with ocular or generalized form followed in Clermont Ferrand University Hospital (MGFA I to IV)

Brief summary: After identifying myasthenic patients meeting the inclusion criteria, telephone contact with patients to suggest that they participate in the study by responding to various questionnaires composed of validated scales used in current practice (MG-ADL, MG-QoL-15, MFIS, FSS, PASS, HADS, Godin-Leisure Exercise Time) which will be completed either digitally (REDCap link) or by paper form if necessary. Consultation of patients' medical records to collect information relating to factors associated with fatigue or intrinsic illness (demographic data, comorbidities, progression of the illness, treatments, etc.).

As part of their usual care, myasthenia patients answer questionnaires according to the following procedure :

1. Mailing of questionnaires to all eligible patients before their consultation The questionnaires are composed of scales validated and used in current practice (MG-ADL, MG-QoL-15, MFIS, FSS, PASS, HADS, Godin-Leisure Exercise Time).
2. Collection of questionnaires When patients come for consultation, the completed questionnaires are collected by the medical team.
3. Collection of questionnaires The responses to the questionnaires and the scores and results obtained from these questionnaires are integrated into the patients' medical records.

As part of our study and in parallel with the patient's clinical follow-up, data relating to factors associated with fatigue or intrinsic illness (demographic data, comorbidities, progression of the disease, treatments, etc.) as well as responses to questionnaires will be collected.


Eligibility criteria: Inclusion Criteria:

* Adult patients who consulted the neurology department of the Clermont-Ferrand University Hospital between 01/01/2022 and 12/31/2024 in the context of their myasthenia and identified by the BAMARA and PMSI databases of the Clermont-Ferrand University Hospital
* Diagnosis of autoimmune myasthenia gravis based on biological and/or electromyographic criteria
* MGFA class from I to IV

Exclusion Criteria:

* Patients under guardianship or curatorship
* Non-French speaking patients
* Patients refusing to participate in the study

Primary outcomes:
measure: Prevalence of fatigue
timeFrame: through study completion, an average of 6 month
Secondary outcomes:
measure: Impact of the fatigue
timeFrame: through study completion, an average of 6 month
Other outcomes:
measure: Associated factors with fatigue
timeFrame: through study completion, an average of 6 month
measure: Associated factors with fatigue
timeFrame: through study completion, an average of 6 month
measure: Associated factors with fatigue
timeFrame: through study completion, an average of 6 month
measure: Associated factors with fatigue
timeFrame: through study completion, an average of 6 month
measure: Associated factors with fatigue
timeFrame: through study completion, an average of 6 month
measure: Associated factors with fatigue
timeFrame: through study completion, an average of 6 month
measure: Associated factors with fatigue
timeFrame: through study completion, an average of 6 month
measure: Associated factors with fatigue
timeFrame: through study completion, an average of 6 month
measure: Associated factors with fatigue
timeFrame: through study completion, an average of 6 month
measure: Associated factors with fatigue
timeFrame: through study completion, an average of 6 month
measure: Associated factors with fatigue
timeFrame: through study completion, an average of 6 month
measure: Associated factors with fatigue
timeFrame: through study completion, an average of 6 month
measure: Associated factors with fatigue
timeFrame: through study completion, an average of 6 month
measure: Associated factors with fatigue
timeFrame: through study completion, an average of 6 month
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Frédéric Taithe
role: PRINCIPAL_INVESTIGATOR
References: