Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
Study NCT ID:
NCT06872450
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2025-02-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Informational Tool for Smoking Cessation in COPD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2025-02-25', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'motivational effectiveness', 'timeFrame': '60 days', 'description': 'Motivation to stop smoking (QMAT test)'}, {'measure': 'motivational effectiveness', 'timeFrame': '60 days', 'description': 'Anxio-depressive state (HAD scale)'}, {'measure': 'motivational effectiveness', 'timeFrame': '60 days', 'description': 'Degree of dependence (Fagerström test)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['informational and motivational tool'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'Chronic obstructive pulmonary disease (COPD) is a lung disease that affects nearly 8% of the adult population and causes 18,000 deaths per year in France. The most frequent cause of this pathology is smoking. COPD patients who stop smoking have a better quality of life, a marked a significant slowdown in disease progression and an increased life expectancy. Investigators propose to carry out a quantitative study among patients smokers suffering from COPD, by setting up a tool in the form of an motivational intervention specific to this population.', 'detailedDescription': 'implementing a tool in the form of an informational intervention with a specific motivational intervention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People suffering from chronic obstructive pulmonary disease (COPD) stage 2/3', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People suffering from chronic obstructive pulmonary disease (COPD) stage 2/3\n* People treated at HNFC\n* Smokers\n\nExclusion Criteria:\n\n* People with cognitive disorders compromising comprehension and completion of the study'}, 'identificationModule': {'nctId': 'NCT06872450', 'acronym': 'IMPACT-BPCO', 'briefTitle': 'Informational Tool for Smoking Cessation in COPD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Nord Franche-Comte'}, 'officialTitle': 'Implementation and Impact Study of an Informational Tool for Smoking Cessation in COPD Patients', 'orgStudyIdInfo': {'id': '2024-11-IMPACT BPCO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'informational intervention', 'description': 'informational intervention', 'interventionNames': ['Other: informational intervention']}], 'interventions': [{'name': 'informational intervention', 'type': 'OTHER', 'description': 'informational intervention', 'armGroupLabels': ['informational intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90400', 'city': 'Trévenans', 'country': 'France', 'facility': 'Hôpital Nord Franche-comté', 'geoPoint': {'lat': 47.56667, 'lon': 6.86667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Nord Franche-Comte', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}