Validation of French Version of LCADL and Dyspnea-12 | NCT02555202

Studies
Validation of French Version of LCADL and Dyspnea-12

NCT02555202

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Mar 31, 2017Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Copd

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

Sep 2016

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

Oct 15, 2015Actual

Primary Completion Date

Sep 30, 2016Actual

Completion Date

Sep 30, 2016Actual

First Submitted Date

Sep 16, 2015

First Submission Date that Met QC Criteria

Sep 18, 2015

First Posted Date

Sep 21, 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

Mar 30, 2017

Last Update Posted Date

Mar 31, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 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).

Detailed Description

Not provided

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

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the Saint-Georges questionnaire, item Activity	by comparison with item activities of the Saint-Georges questionnaire for the LCADL	15 days
MMRC Dyspnea scale	by comparison with MMRC dyspnea scale for the dyspnea 12	15 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COPD with FEV1< 50% of predictive value

Exclusion Criteria:

FEV1> 50% of predictive value
Patients with an exacerbation of COPD in the previous 30 days the inclusion

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

copd patients stage 3 and 4

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francis Couturaud, MD,PhD	CHU BREST, Département de médecine interne et pneumologie EA 3878, CIC INSERM 1412, IFR 148	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brest University hospital		Morlaix		29672	France

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D004417	Dyspnea

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided