Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT03527004
Status:
TERMINATED
Last Update Posted:
2024-02-28
First Post:
2018-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cross-Sectional Survey on the Use of Tobacco Products - Italy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064424', 'term': 'Tobacco Use'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6107}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The study was terminated prematurely after 2 years because during to the COVID-19 pandemic, the face-to-face mode of administration of the interviews in the General Adult Population Sample was not feasible.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2018-05-04', 'studyFirstSubmitQcDate': '2018-05-15', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of current tobacco use', 'timeFrame': 'Study duration (3 years).', 'description': 'Prevalence of current tobacco use status in the study population.'}, {'measure': 'Past tobacco use status', 'timeFrame': 'Study duration (3 years).', 'description': 'Past tobacco use status (cigarette, IQOS and other innovative products) in the study population.'}, {'measure': 'Self-reported health status', 'timeFrame': 'Study duration (3 years).', 'description': 'Association between self-reported health status and use of tobacco products in the study population.'}, {'measure': 'Perceived risk', 'timeFrame': 'Study duration (3 years).', 'description': 'Association between patterns of use with perceived risk.'}, {'measure': 'IQOS use experience', 'timeFrame': 'Study duration (3 years).', 'description': 'Describe the IQOS user experience, including motivation to use, mis-use, satisfaction, and self-reported changes since switching to the product (in a number of relevant domains where IQOS may have potential benefits).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tobacco Use', 'IQOS'], 'conditions': ['Tobacco Use']}, 'descriptionModule': {'briefSummary': 'The main purpose of the research study is to estimate the prevalence of tobacco product use and describe the tobacco use patterns in adults in Italy.', 'detailedDescription': "The aim of the survey is to describe the current and past patterns of use of tobacco products in the general adult population of Italy and in adult IQOS users registered in the IQOS user database of Philip Morris Italia S.r.l. (Italy IQOS User Database), and explore their association with key independent variables. More specifically, the objectives are:\n\n1. Estimate the prevalence of current tobacco use status in the study population.\n2. Describe the past tobacco use status (cigarette, IQOS and other innovative products, including e-cigarettes) in the study population (i.e. never-use, initiation, product use transition, cessation, re-initiation, and relapse).\n3. Explore the association between self-reported health status and use of tobacco products in the study population.\n4. Explore the association between patterns of use (including misuse) with motivation to use, perceived quality attributes of IQOS (e.g. risk and self-reported changes since switching to the product, in a number of relevant domains where IQOS may have potential benefits), and consumer's satisfaction in the population of IQOS users in Italy registered in the Italy IQOS User Database."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be limited to residents of Italy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (all participants, including IQOS users):\n\n* Legally permitted to buy tobacco products in Italy (≥18 years of age).\n* Currently residing in Italy.\n* Able to read, write and understand Italian.\n* Consent to participate in the survey\n\nInclusion Criteria (IQOS users only):\n\n* Has used more than 100 HEETS tobacco sticks in his or her lifetime.\n* Is currently using IQOS.\n* Has access to the internet.\n* Is not currently employed by Philip Morris International or any of its affiliates\n\nExclusion Criteria:\n\n* Not meeting the inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT03527004', 'briefTitle': 'Cross-Sectional Survey on the Use of Tobacco Products - Italy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philip Morris Products S.A.'}, 'officialTitle': 'Cross Sectional Survey on the Use of Tobacco Products in the General Population and in Users of IQOS in Italy (2018-2020)', 'orgStudyIdInfo': {'id': 'P1-PMX-02-IT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General Population', 'description': 'Survey on use of tobacco products in the general population of adults living in Italy.', 'interventionNames': ['Other: Survey on Use of Tobacco Products in the General Population']}, {'label': 'IQOS Users', 'description': 'Survey on use of tobacco products in adult current IQOS Users (at the time of survey) living in Italy who are registered in the Italy IQOS User Database and agreed to be contacted for research purposes at the time of registration.', 'interventionNames': ['Other: Survey on Use of Tobacco Products in IQOS Users']}], 'interventions': [{'name': 'Survey on Use of Tobacco Products in the General Population', 'type': 'OTHER', 'description': 'Face-to-face survey to estimate the prevalence of current tobacco use status in the general population of Italy.', 'armGroupLabels': ['General Population']}, {'name': 'Survey on Use of Tobacco Products in IQOS Users', 'type': 'OTHER', 'description': 'Online survey to describe patterns of use in IQOS users residing in Italy.', 'armGroupLabels': ['IQOS Users']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Philip Morris Products S.A.', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Pierpaolo Magnani', 'role': 'STUDY_CHAIR', 'affiliation': 'Philip Morris Products S.A.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philip Morris Products S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}