Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-27 @ 5:54 AM
Study NCT ID:
NCT00888992
Status:
COMPLETED
Last Update Posted:
2015-04-03
First Post:
2009-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Technology-Enhanced Quitline Services to Prevent Smoking Relapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1785}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-02', 'studyFirstSubmitDate': '2009-04-27', 'studyFirstSubmitQcDate': '2009-04-27', 'lastUpdatePostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant smoking status.', 'timeFrame': '6 and 12 month follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking', 'Cessation', 'Quitline', 'Counseling'], 'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '26124508', 'type': 'DERIVED', 'citation': 'McDaniel AM, Vickerman KA, Stump TE, Monahan PO, Fellows JL, Weaver MT, Carlini BH, Champion VL, Zbikowski SM. A randomised controlled trial to prevent smoking relapse among recently quit smokers enrolled in employer and health plan sponsored quitlines. BMJ Open. 2015 Jun 29;5(6):e007260. doi: 10.1136/bmjopen-2014-007260.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to see if automated telephone monitoring will enhance existing quitline services, such as Alere Wellbeing's Quit For Life program, and help people quit smoking. If successful, this intervention could be incorporated into existing quitline protocols and delivered to millions of people who are trying to quit smoking."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Enrolled in Free \\& Clear, Inc. services\n* Self-reported abstinence for at least 24 hours at the quit date call\n* Able to read and speak English\n* Personal access to a touch-tone telephone or cellular telephone\n\nExclusion Criteria:\n\n* Have not stopped smoking for 24 hours\n* Currently incarcerated\n* Currently participating in any other smoking cessation research\n* Live in same household as another study participant\n* Participated in the Alere Wellbeing Quit for Life Program within the last 6 months\n* Were previously enrolled in this study even if they repeat the smoking cessation program during the accrual period\n* Hearing impaired enrollees receiving Free \\& Clear services via telecommunications devices for the deaf (TDD) will be excluded from the study as the IVR technology currently does not have this capability'}, 'identificationModule': {'nctId': 'NCT00888992', 'acronym': 'TEQ', 'briefTitle': 'Technology-Enhanced Quitline Services to Prevent Smoking Relapse', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Technology-Enhanced Quitline Services to Prevent Smoking Relapse', 'orgStudyIdInfo': {'id': '0812-77B'}, 'secondaryIdInfos': [{'id': '1R01CA138936-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01CA138936-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group A', 'description': "Receive the usual care provided in Alere Wellbeing's Quit For Life® program. The program includes 5 telephone counseling calls."}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'interventionNames': ['Behavioral: Quitline Service + 10 automated monitoring calls']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'interventionNames': ['Behavioral: Quitline service + 20 automated monitoring calls']}], 'interventions': [{'name': 'Quitline Service + 10 automated monitoring calls', 'type': 'BEHAVIORAL', 'description': "This group will receive the usual care provided in Alere Wellbeing's Quit For Life® program. The program includes 5 telephone counseling calls. In addition, participants receive 10 automated telephone monitoring calls to help them stay off cigarettes. The automated call schedule will be two calls per a week for 2 weeks, then once a week for 6 weeks. Participants whose answers indicate that they may be having trouble quitting smoking will be automatically connected to a Quit Coach for individualized relapse prevention counseling.", 'armGroupLabels': ['Group B']}, {'name': 'Quitline service + 20 automated monitoring calls', 'type': 'BEHAVIORAL', 'description': "This group will receive the usual care provided in Alere Wellbeing's Quit For Life® program. The program includes 5 telephone counseling calls. In addition, participants receive 20 automated telephone monitoring calls to help them stay off cigarettes. The automated call schedule will be one automated call a day for 2 weeks, then once a week for 6 weeks. Participants whose answers indicate that they may be having trouble quitting smoking will be automatically connected to a Quit Coach for individualized relapse prevention counseling.", 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Alere Wellbeing (formally known as Free & Clear, Inc.)', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Anna M McDaniel, PhD RN FAAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}, {'name': 'Susan Zbikowski, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consumer Wellness Solutions'}, {'name': 'Katie Witkiewitz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}, {'name': 'Jeffery Fellows, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Consumer Wellness Solutions', 'class': 'INDUSTRY'}, {'name': 'Kaiser Foundation Hospitals, Center for Health Research', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}