Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-26 @ 3:58 AM
Study NCT ID:
NCT02555202
Status:
COMPLETED
Last Update Posted:
2017-03-31
First Post:
2015-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of French Version of LCADL and Dyspnea-12
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-30', 'studyFirstSubmitDate': '2015-09-16', 'studyFirstSubmitQcDate': '2015-09-18', 'lastUpdatePostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the Saint-Georges questionnaire, item Activity', 'timeFrame': '15 days', 'description': 'by comparison with item activities of the Saint-Georges questionnaire for the LCADL'}, {'measure': 'MMRC Dyspnea scale', 'timeFrame': '15 days', 'description': 'by comparison with MMRC dyspnea scale for the dyspnea 12'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dyspnea'], 'conditions': ['Copd']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'copd patients stage 3 and 4', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD with FEV1\\< 50% of predictive value\n\nExclusion Criteria:\n\n* FEV1\\> 50% of predictive value\n* Patients with an exacerbation of COPD in the previous 30 days the inclusion'}, 'identificationModule': {'nctId': 'NCT02555202', 'acronym': 'LCADL', 'briefTitle': 'Validation of French Version of LCADL and Dyspnea-12', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Validation of the French Version of the London Chest Activity of Daily Living Scale (LCADL) and the Dyspnea-12 Questionnaire', 'orgStudyIdInfo': {'id': 'LCADL (RB 15.037)'}}, 'contactsLocationsModule': {'locations': [{'zip': '29672', 'city': 'Morlaix', 'country': 'France', 'facility': 'Brest University hospital', 'geoPoint': {'lat': 48.57784, 'lon': -3.82792}}], 'overallOfficials': [{'name': 'Francis Couturaud, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU BREST, Département de médecine interne et pneumologie EA 3878, CIC INSERM 1412, IFR 148'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}