Skip to main content
OpenTrials
Completed

NCT Number: NCT02470364

Translation, Cross-cultural Adaptation and Validation of the MGQOL-15-F

The purpose of this study is to translate and culturally adapt the MGQOL-15 (health-related quality of life scale for myasthenia gravis) for use with French-speaking patients in France and to evaluate its psychometric properties to ensure reliability and validity.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myasthenia Gravis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Myology, La Pitié-Salpêtrière Hospital

Paris, 75013, France

About this study

It is a translation and validation of a quality of life scale.

Step 1: Translation and cultural adaptation (Forward and back translation, committee review, pre-testing with 10 patients for content and face validity).

Step 2 : Psychometric testing : Test-retest with a 2 day interval, correlation with clinical scores - the Myasthenic Muscle Score and the (MG-ADL) score and with a global quality of life score (WHOQOL-BREF).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Auto-immune myasthenia gravis
  • Age ≥ 18 years old
  • Clinical Classification (MGFA) I-IV
  • French speaking

Exclusion criteria

  • cognitive or visual impairment which would limit the capacity to fill out the MGQOL-15-F

Treatment and study plan

Primary outcomes

  1. Perceived quality of life measured via the MGQOL-15-F (French version of the MGQOL-15), a myasthenia-specific quality of life auto-questionnaire

    Time frame: 3 days

Secondary outcomes

  1. Global quality of life evaluated via the WHOQOL-BREF scale

    Time frame: 1 day

  2. Clinical evaluation : Myasthenic Muscle Score

    Time frame: 1 day

  3. Disease severity assessed via the Myasthenic Muscle Score

    Time frame: 1 day

  4. Impact of symptoms on daily activities and daily life using the MG-ADL score

    Time frame: 1day

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: MGQOL-15-F

Important dates

Study start
2014
Primary completion
2014
First posted
Jun 12, 2015
Registry last updated
Jun 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.