Translation, Cross-cultural Adaptation and Validation of... | NCT02470364

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

NCT02470364

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Jun 15, 2015Estimated

Enrollment

120Actual

Phase

Not provided

Conditions

Myasthenia Gravis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Not provided

First Submitted Date

Jun 10, 2015

First Submission Date that Met QC Criteria

Jun 11, 2015

First Posted Date

Jun 12, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2015

Last Update Posted Date

Jun 15, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Outcomes Module

Primary Outcomes

Measure	Description	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		3 days

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with auto-immune myasthenia gravis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Myology, La Pitié-Salpêtrière Hospital		Paris		75013	France

Condition Browse Module

MeSH Terms

ID	Term
D009157	Myasthenia Gravis

Ancestor Terms

ID	Term
D020361	Paraneoplastic Syndromes, Nervous System
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided