Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-02-26 @ 2:17 AM
Study NCT ID:
NCT01893502
Status:
COMPLETED
Last Update Posted:
2017-04-07
First Post:
2013-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Duration of Follow-Up Counselling on Smoking Cessation Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-06', 'studyFirstSubmitDate': '2013-07-02', 'studyFirstSubmitQcDate': '2013-07-08', 'lastUpdatePostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exhaled carbon monoxide levels', 'timeFrame': '3, 6, 12 months'}], 'primaryOutcomes': [{'measure': 'Seven-day point prevalence abstinence', 'timeFrame': 'Six months'}], 'secondaryOutcomes': [{'measure': 'Average number of cigarettes smoked per day over the past seven days', 'timeFrame': '3, 6, 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'Smoking cessation improves mortality, even in patients with existing smoking-related morbidity. Telephone follow-up after smoking cessation counselling as been shown to be an important method to provide support to smokers and to improve quit rates, especially if three or more calls were used in addition to face-to-face counselling. While it is reasonable to assume that more counselling leads to better smoking cessation outcomes, little evidence exists over the amount of telephone follow-up counselling that is required for optimal and sustained abstinence. We aim to investigate if six-months of weekly telephone follow-up is superior to one-month of weekly telephone follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current smokers among outpatients, including hospital employees, who provide informed consent for enrollment in the smoking cessation program\n\nExclusion Criteria:\n\n* Subjects who decline smoking cessation or who do not provide informed consent\n* Subjects who are participating or will be participating in other smoking cessation programs within the next six months\n* Subjects who are currently using smoking cessation medications\n* Subjects who cannot be followed up for at least six months, for instance, subjects who would be resigning and going overseas within the next six months\n* Subjects with language limitations that would impede completion of self-administered questionnaires\n* Subjects who are difficult to communicate with over the telephone (e.g. having speech or hearing problems)\n* Subjects with cognitive impairments that would impede counselling and follow-up\n* Subjects with no telephone number\n* Subjects who are too sick to receive smoking cessation counselling\n* Subjects with limited life expectancy (e.g. metastatic cancer)'}, 'identificationModule': {'nctId': 'NCT01893502', 'briefTitle': 'Duration of Follow-Up Counselling on Smoking Cessation Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'officialTitle': 'Smoke Free Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2013/00057'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Participants will receive weekly proactive and live telephone counselling from Quitline (run by the Health Promotion Board) for one month', 'interventionNames': ['Behavioral: Telephone counselling from Quitline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Participants will receive weekly proactive and live telephone counselling from Quitline (run by the Health Promotion Board) for six months', 'interventionNames': ['Behavioral: Telephone counselling from Quitline']}], 'interventions': [{'name': 'Telephone counselling from Quitline', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119228', 'city': 'Singapore', 'state': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Kay C See, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University Hospital, Singapore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. See Kay Choong', 'investigatorFullName': 'Medicine', 'investigatorAffiliation': 'National University Hospital, Singapore'}}}}