NCT02555202

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 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

First Submitted

Initial submission to the registry

September 16, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

October 15, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
Last Updated

March 31, 2017

Status Verified

September 1, 2016

Enrollment Period

12 months

First QC Date

September 16, 2015

Last Update Submit

March 30, 2017

Conditions

Copd

Keywords

dyspnea

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

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

copd patients stage 3 and 4

You may qualify if:

  • COPD with FEV1\< 50% of predictive value

You may not qualify if:

  • FEV1\> 50% of predictive value

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brest University hospital

Morlaix, 29672, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Francis Couturaud, MD,PhD

    CHU BREST, Département de médecine interne et pneumologie EA 3878, CIC INSERM 1412, IFR 148

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 16, 2015

First Posted

September 21, 2015

Study Start

October 15, 2015

Primary Completion

September 30, 2016

Study Completion

September 30, 2016

Last Updated

March 31, 2017

Record last verified: 2016-09

Locations

FR(1)