CopdLCADLNCT02555202
Validation of French Version of LCADL and Dyspnea-12
An observational study of Copd, run by University Hospital, Brest at 1 site in France.
Trial summary
The main objective of this study is to develop and to validate a French version of the London Chest Activity of Daily Living (LCADL) and the Dyspnea 12 and to determine the reliability of this version for the evaluation of the dyspnea in the Activity of Daily Living in COPD patients (stages severe and very severe). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Copd
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2015to 30 Sep 2016
- 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: copd patients stage 3 and 4
Who may be able to join
- COPD with FEV1< 50% of predictive value
Who cannot join
- FEV1> 50% of predictive value
- Patients with an exacerbation of COPD in the previous 30 days the inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the French Version of the London Chest Activity of Daily Living Scale (LCADL) and the Dyspnea-12 Questionnaire
The main objective of this study is to develop and to validate a French version of the London Chest Activity of Daily Living (LCADL) and the Dyspnea 12 and to determine the reliability of this version for the evaluation of the dyspnea in the Activity of Daily Living in COPD patients (stages severe and very severe).
- Conditions
- Copd
- Keywords
- dyspnea
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What is being measured
The primary outcome is the main question the study is designed to answer.
the Saint-Georges questionnaire, item Activity
by comparison with item activities of the Saint-Georges questionnaire for the LCADL
Measured: 15 days
MMRC Dyspnea scale
by comparison with MMRC dyspnea scale for the dyspnea 12
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study start15 Oct 2015
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis Couturaud, MD,PhD, Principal investigator, CHU BREST, Département de médecine interne et pneumologie EA 3878, CIC INSERM 1412, IFR 148
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555202
- Sponsor's protocol ID
- LCADL (RB 15.037)
- Acronym
- LCADL
- Status last verified
- Sep 2016
- First submitted
- 16 Sep 2015
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Version of the London Chest Activity of Daily Living Scale (LCADL) and the Dyspnea-12 Questionnaire
- ClinicalTrials.gov ID
- NCT02555202
- Acronym / sponsor ID
- LCADL / LCADL (RB 15.037)
- Conditions
- Copd
- Keywords
- dyspnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 21 Sep 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 main objective of this study is to develop and to validate a French version of the London Chest Activity of Daily Living (LCADL) and the Dyspnea 12 and to determine the reliability of this version for the evaluation of the dyspnea in the Activity of Daily Living in COPD patients (stages severe and very severe).
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
- copd patients stage 3 and 4
Key inclusion criteria (1 listed)
- COPD with FEV1< 50% of predictive value
Key exclusion criteria (2 listed)
- FEV1> 50% of predictive value
- Patients with an exacerbation of COPD in the previous 30 days the inclusion
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
the Saint-Georges questionnaire, item Activity
Time frame: 15 days
by comparison with item activities of the Saint-Georges questionnaire for the LCADL
MMRC Dyspnea scale
Time frame: 15 days
by comparison with MMRC dyspnea scale for the dyspnea 12
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 31 Mar 2017.
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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.
Francis Couturaud, MD,PhD principal investigator
CHU BREST, Département de médecine interne et pneumologie EA 3878, CIC INSERM 1412, IFR 148
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 Copd, run by University Hospital, Brest 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 1 inclusion and 2 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 31 Mar 2017. 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?
the Saint-Georges questionnaire, item Activity (time frame: 15 days). The study lists 2 primary outcomes in all. 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 31 Mar 2017.