Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-31 @ 8:02 PM
Study NCT ID:
NCT01296295
Status:
UNKNOWN
Last Update Posted:
2011-02-15
First Post:
2010-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Regular Reporting of Spirometric Results on Smoking Quit Rate.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 466}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-02-13', 'studyFirstSubmitDate': '2010-07-30', 'studyFirstSubmitQcDate': '2011-02-13', 'lastUpdatePostDateStruct': {'date': '2011-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking abstinence: self reported abstinence (12 or more months smoking free.', 'timeFrame': '24 months after last recruitment', 'description': 'Smoking cessation confirmed by air carbon monoxide concentration. Safety Issue?: (FDAAA) No'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['smoking cessation advice', 'spirometry', 'primary health care'], 'conditions': ['Smoking Cessation', 'COPD']}, 'referencesModule': {'references': [{'pmid': '21708047', 'type': 'DERIVED', 'citation': 'Rodriguez-Alvarez M, Toran-Monserrat P, Munoz-Ortiz L, Negrete-Palma A, Montero-Alia JJ, Jimenez-Gonzalez M, Zurilla-Leonarte E, Marina-Ortega V, Olle-Borque M, Valentin-Moya E, Cortada-Cabrera A, Tena-Domingo A, Martinez-Gonzalez S, Vila-Palau V, Ramos-Ordonez A, Rotllant-Estelrich G, Forcada-Vega C, Borrell-Thio E. Effectiveness of regular reporting of spirometric results combined with a smoking cessation advice by a primary care physician on smoking quit rate in adult smokers: a randomized controlled trial. ESPIROTAB study. BMC Fam Pract. 2011 Jun 28;12:61. doi: 10.1186/1471-2296-12-61.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of regular reporting of spirometric results combined with smoking cessation advice on smoking quit rate in adult smokers in primary care.\n\nHypothesis: In adult smokers, regular reporting of spirometric test results in addition with smoking cessation advice will increase smoking quit rate.\n\nExpected outcome: increase of smoking cessation rate .', 'detailedDescription': 'Design: Intervention study with two randomized arms in 5 primary care centers of two health areas.\n\nStudy population: 466 smokers over the age of 18 consulting their primary care physician for any reason and who do not fulfil the exclusion criteria.\n\nMeasurements and interventions: The study data will be collected using a structured questionnaire and data collection sheets specifically designed for the study The structured questionnaire will include the following data: sociodemographics, clinical history, smoking habit, respiratory symptomatology, smoking dependence test and smoking cessation motivation test.\n\nThe data collection sheets will include information related to the spirometric results, peak expiratory flow rate and the carbon monoxide test when performed.\n\nOn visit 0, the primary care physician will give a brief structured smoking cessation advice to all patients combined with a detailed and structured discussion of the spirometric results. After this visit the patients will be randomised in two arms (control and intervention groups).\n\nRandomisation will be performed using a computer programme.\n\nRandomisation will be carried out by the Coordinating Centre.\n\nBoth groups will be followed up by telephone at three (visit 1) and six months (visit 2) and at one-year (visit 3) and two-year(visit 4).\n\nDuring the follow up visits brief structured smoking cessation advice will be reinforced in the control group but the spirometric results will not be discussed. In the intervention group brief structured smoking cessation advice will be reinforced with a detailed structured reminder discussion of the results obtained from the spyrometry of visit 0.\n\nFollow up visits 1 and 2 will be undertaken by telephone and the patients will be asked about their smoking habit and will be given a brief questionnaire.\n\nOne month before visits 3 and 4 both groups will undergo the same series of tests performed prior to visit 0 with the exception of the peak expiratory flow rate. Spirometry will be done only in the intervention group.\n\nOn visits 3 and 4, the same intervention will be done. On both visits 3 and 4 all the participants who report smoking withdrawal will undergo the carbon monoxide test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult smoker population over the age of 18 years attended by their primary care physician for any reason and who do not fulfil exclusion criteria\n\nExclusion Criteria:\n\n* Previous diagnosis of COPD by spirometry.\n* Patients contraindicated to undertake spirometry.\n* Patients without a telephone.\n* Patients with communication difficulties: cognitive and/or sensorial deterioration, language.\n* Patients with severe disease of poor prognosis (life expectancy of less than one year).\n* Patients with another respiratory disease: asthma, COPD, neoplasm of the respiratory tract, pulmonary thromboembolism, pulmonary tuberculosis, interstitial diseases.\n* Patients who do not give written informed consent to participate in the study.'}, 'identificationModule': {'nctId': 'NCT01296295', 'acronym': 'ESPIROTAB', 'briefTitle': 'Effectiveness of Regular Reporting of Spirometric Results on Smoking Quit Rate.', 'organization': {'class': 'OTHER', 'fullName': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}, 'officialTitle': 'Effectiveness of Regular Reporting of Spirometric Results Combined With a Smoking Cessation Advice by a Primary Care Physician on Smoking Quit Rate in Adult Smokers: a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'P10/40.'}, 'secondaryIdInfos': [{'id': 'Jordi Gol i Gurina Foundation', 'type': 'REGISTRY', 'domain': 'P10/40'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spirometry and lifestyle counseling', 'description': 'Intervention group: The intervention is to give brief structured smoking cessation advice combined with a detailed and structured discussion of the spirometric results.', 'interventionNames': ['Behavioral: Lifestyle counseling and spirometry']}, {'type': 'NO_INTERVENTION', 'label': 'Lifestyle counseling', 'description': 'No intervention group: the patients of the control group will receive a brief structured smoking cessation advice.', 'interventionNames': ['Behavioral: Smoking cessation advice']}], 'interventions': [{'name': 'Lifestyle counseling and spirometry', 'type': 'BEHAVIORAL', 'description': 'The patients of the intervention group will be given a brief structured smoking cessation advice by their primary care physician combined with a detailed and structured discussion of the spirometry results.', 'armGroupLabels': ['Spirometry and lifestyle counseling']}, {'name': 'Smoking cessation advice', 'type': 'BEHAVIORAL', 'description': 'Brief smoking cessation advice', 'armGroupLabels': ['Lifestyle counseling']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Jordi Gol i Gurina Foundation', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Mar Rodriguez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Catalá de la Salut'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina", 'class': 'OTHER'}, 'collaborators': [{'name': 'Catalan Institute of Health', 'class': 'OTHER_GOV'}, {'name': 'Research Support Unit Metropolitana Nord, Barcelona, Spain', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Maria del Mar Rodriguez Alvarez', 'oldOrganization': 'Catalan Health Institute'}}}}