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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT02470364
Collaborator
(none)
120
Enrollment
1
Location

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Translation, Cross-cultural Adaptation and Validation of the MGQOL-15-F
    Study Start Date :
    Jun 1, 2014
    Actual Primary Completion Date :
    Dec 1, 2014

    Outcome Measures

    Primary Outcome Measures

    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 [3 days]

    Secondary Outcome Measures

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

    2. Clinical evaluation : Myasthenic Muscle Score [1 day]

    3. Disease severity assessed via the Myasthenic Muscle Score [1 day]

    4. Impact of symptoms on daily activities and daily life using the MG-ADL score [1day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institute of Myology, La Pitié-Salpêtrière Hospital Paris France 75013

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT02470364
    Other Study ID Numbers:
    • MGQOL-15
    First Posted:
    Jun 12, 2015
    Last Update Posted:
    Jun 15, 2015
    Last Verified:
    Oct 1, 2014
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Myasthenia gravis
    Quality of life
    Additional relevant MeSH terms:
    Myasthenia Gravis

    Study Results

    No Results Posted as of Jun 15, 2015