Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT00954967
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2009-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial for Tobacco Cessation With Intensive Advice in Diabetic Patients: the ITADI Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 722}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-05', 'studyFirstSubmitDate': '2009-08-06', 'studyFirstSubmitQcDate': '2009-08-06', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking abstinence: Self reported abstinence (6 or more months without smoking) confirmed by an expired air carbon monoxide concentration of 6 parts per millions or less', 'timeFrame': '12 months after initiation of study'}], 'secondaryOutcomes': [{'measure': 'Evolution of the phases of change of the Prochaska and DiClemente model', 'timeFrame': '12 months after initiation of the study'}, {'measure': 'Number of cigarettes per day', 'timeFrame': '12 months after initiation of the study'}, {'measure': 'Total time (minutes) spent in the intensive smoking cessation intervention', 'timeFrame': '12 months after initiation of the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Smoking Cessation', 'Primary Health Care', 'Motivational Interview'], 'conditions': ['Diabetes Mellitus', 'Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '20132540', 'type': 'DERIVED', 'citation': 'Roig L, Perez S, Prieto G, Martin C, Advani M, Armengol A, Roura P, Manresa JM, Briones E; ITADI Study Group. Cluster randomized trial in smoking cessation with intensive advice in diabetic patients in primary care. ITADI Study. BMC Public Health. 2010 Feb 4;10:58. doi: 10.1186/1471-2458-10-58.'}]}, 'descriptionModule': {'briefSummary': 'This study addresses an important problem in public health, smoking in diabetics. The morbidity and mortality observed in diabetics is linked to macro and microvascular problems. The consumption of tobacco has a multiplying effect on these vascular problems in diabetics. This study aims to evaluate the effectiveness of an intensive intervention in tobacco addiction in diabetic patients in primary care.', 'detailedDescription': 'Other objectives of the study are:\n\n1. To study the effectiveness of an intensive smoking cessation intervention in the evolution of the phases of change, as based on the Prochaska and DiClemente model, in diabetic patients attended in primary care.\n2. To evaluate the effectiveness of an intensive smoking cessation intervention in the evolution of tabacco consumption in diabetic patients attended in primary care.\n3. To quantify the time spent in the intensive smoking cessation intervention compared with the usual care in primary care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetic patients who are active smokers\n* over the age of 14\n* receive routine care in their respective health center\n\nExclusion Criteria:\n\n* patients with communication difficulties (cognitive deterioration, language barrier)\n* patients who normally receive their habitual care in a different health center\n* patients with terminal diseases, psychiatric diseases that are unstable, or with addictions to other substances\n* patients that are already receiving treatment to quit smoking at the time of recruitment\n* patients that are difficult to locate during the study period\n* patients that refuse to participate in the study'}, 'identificationModule': {'nctId': 'NCT00954967', 'acronym': 'ITADI', 'briefTitle': 'Trial for Tobacco Cessation With Intensive Advice in Diabetic Patients: the ITADI Project', 'organization': {'class': 'OTHER', 'fullName': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}, 'officialTitle': 'Community Intervention Trial for Smoking Cessation With Intensive Advice in Diabetic Patients in Primary Health Care', 'orgStudyIdInfo': {'id': 'PI08/90345'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'The subjects in the control group will receive the usual care for smoking cessation in diabetic smokers.'}, {'type': 'EXPERIMENTAL', 'label': 'Lifestyle Counseling', 'description': 'The intervention is based on lifestyle advice, motivational interviewing and the use of medications, using the Clinical Practice Guidelines of the Catalan Institute of Health. Health professionals in the intervention group receive a training on the abovementioned techniques.', 'interventionNames': ['Behavioral: Lifestyle Counseling']}], 'interventions': [{'name': 'Lifestyle Counseling', 'type': 'BEHAVIORAL', 'description': 'The intervention is based on lifestyle advice, motivational interviewing and the use of medications, using the Clinical Practice Guidelines of the Catalan Institute of Health. Health professionals in the intervention group receive a training on the abovementioned techniques.', 'armGroupLabels': ['Lifestyle Counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08007', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'IDIAP Jordi Gol', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Santiago Pérez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CAP La Llagosta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina", 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut Catala de Salut', 'class': 'OTHER_GOV'}, {'name': 'Consorci Sanitari de Terrassa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'USR Metropolitana Nord', 'investigatorAffiliation': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}}}}