NCT02470364

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
Last Updated

June 15, 2015

Status Verified

October 1, 2014

Enrollment Period

6 months

First QC Date

June 10, 2015

Last Update Submit

June 12, 2015

Conditions

Myasthenia Gravis

Keywords

Myasthenia gravisQuality of life

Outcome Measures

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

    3 days

Secondary Outcomes (4)

  • Global quality of life evaluated via the WHOQOL-BREF scale

    1 day

  • Clinical evaluation : Myasthenic Muscle Score

    1 day

  • Disease severity assessed via the Myasthenic Muscle Score

    1 day

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

    1day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with auto-immune myasthenia gravis

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Myology, La Pitié-Salpêtrière Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Simone Birnbaum, Physiotherapist

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 12, 2015

Study Start

June 1, 2014

Primary Completion

December 1, 2014

Last Updated

June 15, 2015

Record last verified: 2014-10

Locations

FR(1)