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临床试验/NCT06877403
NCT06877403Enrolling By Invitation不适用

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

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
100
试验地点
1
主要终点
Prevalence of fatigue

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Prevalence of fatigue

时间窗: 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.

次要结局

  • Impact of the fatigue(through study completion, an average of 6 month)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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