Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-01 @ 11:37 PM
Study NCT ID:
NCT01746069
Status:
COMPLETED
Last Update Posted:
2015-10-21
First Post:
2012-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Messages to Mobile Phone in Smoke Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-02-14', 'releaseDate': '2016-12-23'}, {'resetDate': '2020-03-25', 'releaseDate': '2020-03-13'}], 'estimatedResultsFirstSubmitDate': '2016-12-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D058496', 'term': 'Smith-Magenis Syndrome'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D021081', 'term': 'Chronobiology Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-20', 'studyFirstSubmitDate': '2012-12-07', 'studyFirstSubmitQcDate': '2012-12-07', 'lastUpdatePostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'other variables', 'timeFrame': 'at baseline', 'description': 'Sex (male / female), age (years), number of cigarettes per day before starting program, age of start smoking (years), smoke related pathology (Yes/No), score on the anxiety scale Goldberg, previous attempts to quit smoking (Yes / No if yes, specify number of attempts and reasons for relapse), ), smoking dependence fagerström test score), type of smoker (occasional / daily).'}], 'primaryOutcomes': [{'measure': 'Coximetry test (positive/negative)', 'timeFrame': 'at 6 months'}], 'secondaryOutcomes': [{'measure': 'Continuous abstinence at 6 months: Yes / No', 'timeFrame': 'At 6 months', 'description': 'Continuous Abstinence is defined as smoking more than 5 cigarettes since the beginning of the follow-up period self-reported by the patient.'}, {'measure': 'Abstinence point during the first 7 days self-reported by the patient: Yes / No.', 'timeFrame': 'at first week', 'description': 'Abstinence is defined as not smoking anything punctual during the last seven days.'}, {'measure': '-Prevalence abstinence at the 4th week self-reported by the patient: Yes / No.', 'timeFrame': 'At 4th week'}, {'measure': '-Prevalence abstinence at 12th week self-reported by the patient: Yes / No.', 'timeFrame': 'At 12th week'}, {'measure': '-Outcome of coxymetry test at 12 months of start: Positive / Negative.', 'timeFrame': 'at 12 months', 'description': 'Only in patients with a negative result in the 6 months test'}, {'measure': 'Number of messages requested by the patient anxiety.', 'timeFrame': 'at 12 months'}, {'measure': 'slip: Yes / No.', 'timeFrame': 'at 12 months', 'description': 'Treated as the first use (consumption point) after a period of abstinence'}, {'measure': '- Relapse: Yes / No.', 'timeFrame': 'At 12 months', 'description': 'Relapse is defined to return dependent behavior that had tried to change, recovering or not the baseline levels before treatment.'}, {'measure': 'Number of messages relapse-slip timely requested by the patient.', 'timeFrame': 'At 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['smoking', 'smoke cessation', 'sms', 'quit smoke'], 'conditions': ['Smoking']}, 'descriptionModule': {'briefSummary': 'Smoking remains a major risk factor for chronic diseases and is a real problem for health systems. The use of emerging technologies, such as mobile phone , may have a important role in smoking cessation programs through sending reinforcement messages when patients quits smoking.\n\nMain objective: To evaluate the effectiveness of a combined 6 months smoking cessation program including health advice provided by a doctor and sending support messages to mobile phone of patients.\n\nMethods: Study design: Randomized single blind clinical trial. Study population: Patients over 18 who are willing to start a smoking cessation program, who have mobile phone, who are able to receive and send messages, and who have a score greater than 5 or equal to 5 on the Richmond scale.\n\nSample size: 160 patients per arm to detect a difference in the percentage of smoking cessation than 10% (14.9% vs. 4.9%) between the two groups. Intervention: Experimental group: Health advice and support messages to mobile phone patients.\n\nControl group: Health advice. Assessment of the primary endpoint: At 6 months (positive/negative coximetry test).\n\nStatistical analysis: The analysis of the primary endpoint (positive / negative coximetry test) will be performed using logistic regression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years.\n* Current smoker (25): Current smoker is defined as the person who at the time of the study beginning declares that smoked daily or occasionally.\n* Possessing mobile phone.\n* Able to receive and send messages through mobile phone.\n* Score greater than 5 or equal to 5 on the Richmond scale\n\nExclusion criteria:\n\n* People with a history of mental and behavioral disorders.\n* Patients with a diagnosis of depression using the depression subscale of Goldberg (two or more positive responses).\n* Patients who with pharmacological therapy for smoking cessation or who require it throughout the study.\n* Pregnant women.'}, 'identificationModule': {'nctId': 'NCT01746069', 'briefTitle': 'Effectiveness of Messages to Mobile Phone in Smoke Cessation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Basque Health Service'}, 'officialTitle': 'Evaluation of a Reinforcement Program Using Text Messages Through Mobile Phone in Smoking Cessation Programs in Primary Care', 'orgStudyIdInfo': {'id': 'TAB-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'health advice', 'description': 'clinical practice routine', 'interventionNames': ['Behavioral: health advice']}, {'type': 'EXPERIMENTAL', 'label': 'Quit smoking combined cessation programme', 'description': "Health advice and support sms messages to patient's mobile phone + clinical routine practice", 'interventionNames': ['Behavioral: Quit smoking combined cessation programme']}], 'interventions': [{'name': 'Quit smoking combined cessation programme', 'type': 'BEHAVIORAL', 'description': "Support sms messages to patient's mobile phone and health advice", 'armGroupLabels': ['Quit smoking combined cessation programme']}, {'name': 'health advice', 'type': 'BEHAVIORAL', 'description': 'routine clinical practice', 'armGroupLabels': ['health advice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01009', 'city': 'Vitoria-Gasteiz', 'state': 'Alava', 'country': 'Spain', 'facility': 'Health centre Lakuabizkarra', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Basque Health Service', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'pharmaceutical', 'investigatorFullName': 'Raquel Cobos Campos', 'investigatorAffiliation': 'Basque Health Service'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-12-23', 'type': 'RELEASE'}, {'date': '2017-02-14', 'type': 'RESET'}, {'date': '2020-03-13', 'type': 'RELEASE'}, {'date': '2020-03-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Raquel Cobos Campos, pharmaceutical, Basque Health Service'}}}}