Myasthenia GravisMGQOL-15-FNCT02470364
Translation, Cross-cultural Adaptation and Validation of the MGQOL-15-F
An observational study of Myasthenia Gravis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with auto-immune myasthenia gravis
Who may be able to join
- Auto-immune myasthenia gravis
- Age ≥ 18 years old
- Clinical Classification (MGFA) I-IV
- French speaking
Who cannot join
- cognitive or visual impairment which would limit the capacity to fill out the MGQOL-15-F
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Myasthenia Gravis
- Keywords
- Myasthenia gravis, Quality of life
- Medical subject headings
- Myasthenia Gravis
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived quality of life measured via the MGQOL-15-F (French version of the MGQOL-15), a myasthenia-specific quality of life auto-questionnaire
Measured: 3 days
Secondary outcomes (4)
Global quality of life evaluated via the WHOQOL-BREF scale
Measured: 1 day
Clinical evaluation : Myasthenic Muscle Score
Measured: 1 day
Disease severity assessed via the Myasthenic Muscle Score
Measured: 1 day
Impact of symptoms on daily activities and daily life using the MG-ADL score
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startJun 2014
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone Birnbaum, Physiotherapist, Principal investigator, Institute of Myology, La Pitié-Salpêtrière Hospital, 75013 Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470364
- Sponsor's protocol ID
- MGQOL-15
- Acronym
- MGQOL-15-F
- Status last verified
- Oct 2014
- First submitted
- 10 Jun 2015
- Last updated
- 15 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Cross-cultural Adaptation and Validation of the MGQOL-15-F
- ClinicalTrials.gov ID
- NCT02470364
- Acronym / sponsor ID
- MGQOL-15-F / MGQOL-15
- Conditions
- Myasthenia Gravis
- Keywords
- Myasthenia gravis, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with auto-immune myasthenia gravis
Key inclusion criteria (4 listed)
- Auto-immune myasthenia gravis
- Age ≥ 18 years old
- Clinical Classification (MGFA) I-IV
- French speaking
Key exclusion criteria (1 listed)
- cognitive or visual impairment which would limit the capacity to fill out the MGQOL-15-F
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Global quality of life evaluated via the WHOQOL-BREF scale
Time frame: 1 day
Clinical evaluation : Myasthenic Muscle Score
Time frame: 1 day
Disease severity assessed via the Myasthenic Muscle Score
Time frame: 1 day
Impact of symptoms on daily activities and daily life using the MG-ADL score
Time frame: 1day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Birnbaum, Physiotherapist principal investigator
Institute of Myology, La Pitié-Salpêtrière Hospital, 75013 Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2015.