Prevalence and Impact of Fatigue in Myasthenic Patients Followed At Clermont-Ferrand University Hospital - "My" Asthenia

March 10, 2025 updated by: University Hospital, Clermont-Ferrand

Prospective Study on the Prevalence and Impact of Fatigue in Myasthenic Patients Followed At Clermont-Ferrand University Hospital - "My" Asthenia

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.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Myasthenic patients with ocular or generalized form followed in Clermont Ferrand University Hospital (MGFA I to IV)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patients suffering from myasthenia gravis (MGFA I to IV) followed in Clermont-Ferrand
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of fatigue
Time Frame: through study completion, an average of 6 month
Determine the prevalence of fatigue in myasthenic patients followed at the Clermont-Ferrand University Hospital by the Fatigue Severity Scale from 1 to 7. 1 = not significative fatigue. 7 = extreme fatigue. Significant if FSS > 4.
through study completion, an average of 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of the fatigue
Time Frame: through study completion, an average of 6 month
Describe the impact of fatigue on daily life by the Modified Fatigue Impact Scale from 21 to 84. 21 = not significative impact of fatigue on daily life, 84 = severe impact of the fatigue. Significant if MFIS > 45.
through study completion, an average of 6 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Associated factors with fatigue
Time Frame: through study completion, an average of 6 month
Study the factors associated with fatigue. Disease severity by MG-ADL (from 0 to 24), 0 means no symptom, 24 means severe symptoms. No specific threshold.
through study completion, an average of 6 month
Associated factors with fatigue
Time Frame: through study completion, an average of 6 month
Study the factors associated with fatigue. Impact of the disease on the daily-life activities by the MG-QoL-15 (from 0 to 60), 0 means no repercussion, 60 means massive repercussion. No specific threshold.
through study completion, an average of 6 month
Associated factors with fatigue
Time Frame: through study completion, an average of 6 month
Study the factors associated with fatigue. Level of anxiety and depression by HADS (< 7 : no symptoms, 8 -11 doubt, > 11 symptoms of anxiety and depression)
through study completion, an average of 6 month
Associated factors with fatigue
Time Frame: through study completion, an average of 6 month
Study the factors associated with fatigue. level of physical activity by Godin Leisure Time Activity Questionnaire (> 24 : active, 14-23 moderate activity, < 14 sedentary)
through study completion, an average of 6 month
Associated factors with fatigue
Time Frame: through study completion, an average of 6 month
Study the factors associated with fatigue. Global feeling about the myasthenia by a simple question with the PASS (yes / no)
through study completion, an average of 6 month
Associated factors with fatigue
Time Frame: through study completion, an average of 6 month
Study the factors associated with fatigue. Analysis of the medical record for demographic : age in years.
through study completion, an average of 6 month
Associated factors with fatigue
Time Frame: through study completion, an average of 6 month
Study the factors associated with fatigue. Analysis of the medical record for demographic : weight in kilograms, height in meters, BMI in kg/m2
through study completion, an average of 6 month
Associated factors with fatigue
Time Frame: through study completion, an average of 6 month
Study the factors associated with fatigue. Analysis of the medical record for demographic : duration of the disease in years
through study completion, an average of 6 month
Associated factors with fatigue
Time Frame: through study completion, an average of 6 month
Study the factors associated with fatigue. Analysis of the medical record for demographic : type of actual or passed treatment : corticoids, anticholinesterasic, immunosuppressive (Azathioprine, Mycophenolate mofetil, Ciclosporine, Rituximab), novel therapy (Efgartigimod-alpha, Zilucoplan, Ravulizumab). Yes or No for each treatment.
through study completion, an average of 6 month
Associated factors with fatigue
Time Frame: through study completion, an average of 6 month
Study the factors associated with fatigue. Analysis of the medical record for demographic : dosage of actual or passed treatment (corticoids, anticholinesterasic, immunosuppressive (Azathioprine, Mycophenolate mofetil, Ciclosporine, Rituximab), novel therapy (Efgartigimod-alpha, Zilucoplan, Ravulizumab). Dosage in mg per day
through study completion, an average of 6 month
Associated factors with fatigue
Time Frame: through study completion, an average of 6 month
Study the factors associated with fatigue. Analysis of the medical record for demographic and notably comorbidities : auto-immune (dysthyroiditis, diabete, lupus, rheumatoid arthritis, other). Yes or No.
through study completion, an average of 6 month
Associated factors with fatigue
Time Frame: through study completion, an average of 6 month
Study the factors associated with fatigue. Analysis of the medical record for demographic and notably comorbidities : thymectomy. Yes or No.
through study completion, an average of 6 month
Associated factors with fatigue
Time Frame: through study completion, an average of 6 month
Study the factors associated with fatigue. Analysis of the medical record for demographic and notably comorbidities : date of the last myasthenic crisis. Month and years or the year exclusively.
through study completion, an average of 6 month
Associated factors with fatigue
Time Frame: through study completion, an average of 6 month
Study the factors associated with fatigue. Analysis of the medical record for demographic and notably comorbidities : date of the last use of crisis treatment (Immunoglobulin, Plasmatic Exchange). Date in month and years or the year exclusively.
through study completion, an average of 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Frédéric Taithe, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2025

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025 TAITHE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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