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

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ClinicalTrials.gov Identifier: NCT02470364
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : June 15, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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
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).


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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 : June 2014
Actual Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine





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 [ Time Frame: 3 days ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with auto-immune myasthenia gravis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470364


Locations
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France
Institute of Myology, La Pitié-Salpêtrière Hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Simone Birnbaum, Physiotherapist Institute of Myology, La Pitié-Salpêtrière Hospital, 75013 Paris, France

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02470364     History of Changes
Other Study ID Numbers: MGQOL-15
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: June 15, 2015
Last Verified: October 2014
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Myasthenia gravis
Quality of life
Additional relevant MeSH terms:
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Myasthenia Gravis
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases