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

June 12, 2015 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Myasthenia Gravis

Detailed 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).

Study Type

Observational

Enrollment (Actual)

120

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
- - Paris, France, 75013
    - Institute of Myology, La Pitié-Salpêtrière Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with auto-immune myasthenia gravis

Description

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 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

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	3 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Global quality of life evaluated via the WHOQOL-BREF scale Time Frame: 1 day	1 day
Clinical evaluation : Myasthenic Muscle Score Time Frame: 1 day	1 day
Disease severity assessed via the Myasthenic Muscle Score Time Frame: 1 day	1 day
Impact of symptoms on daily activities and daily life using the MG-ADL score Time Frame: 1day	1day

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Simone Birnbaum, Physiotherapist, Institute of Myology, La Pitié-Salpêtrière Hospital, 75013 Paris, France

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

June 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 10, 2015

First Submitted That Met QC Criteria

June 11, 2015

First Posted (Estimate)

June 12, 2015

Study Record Updates

Last Update Posted (Estimate)

June 15, 2015

Last Update Submitted That Met QC Criteria