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

Myasthenia Gravis Clinical Trial

— MGQOL-15-F  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470364
• Other study ID #: MGQOL-15
• Status: Completed
• Phase: N/A
• First received: June 10, 2015
• Last updated: June 12, 2015
• Start date: June 2014

Study information

• Verified date: October 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myasthenia Gravis

Locations

Country	Name	City	State
France	Institute of Myology, La Pitié-Salpêtrière Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived quality of life measured via the MGQOL-15-F (French version of the MGQOL-15), a myasthenia-specific quality of life auto-questionnaire		3 days	No
Secondary	Global quality of life evaluated via the WHOQOL-BREF scale		1 day	No
Secondary	Clinical evaluation : Myasthenic Muscle Score		1 day	No
Secondary	Disease severity assessed via the Myasthenic Muscle Score		1 day	No
Secondary	Impact of symptoms on daily activities and daily life using the MG-ADL score		1day	No