Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2026-01-26 @ 1:02 PM
Study NCT ID:
NCT00665704
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2008-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tobacco Tactics Website for Veteran Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Sonia.Duffy@va.gov', 'phone': '734.395.0613', 'title': 'Sonia A. Duffy, Ph.D., R.N., FAAN', 'organization': 'VA Center for Clinical Management Research Health Services Research & Development, VA Ann Arbor Healthcare System, Ann Arbor, MI.'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tobacco Tactics Website', 'description': 'Nine veteran smokers who will pilot test the Tobacco Tactics website\n\nTobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Self Reported 30 Day Smoking Quit Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobacco Tactics Website', 'description': 'Nine veteran smokers who will pilot test the Tobacco Tactics website\n\nTobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days post intervention', 'description': 'Impact evaluation was the 30-day quit rates of the 9 veteran smokers that agreed to use the website.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Feedback to Evaluate the Website', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobacco Tactics Website', 'description': 'Nine veteran smokers who will pilot test the Tobacco Tactics website\n\nTobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers'}], 'classes': [{'title': 'easy to read', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'enjoyable', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'easy to navigate', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days post intervention', 'description': 'Formative evaluation during pre-testing included qualitative feedback on the: 1) ability to accomplish tasks; 2) ability to accomplish goals with skill and speed; 3) ability to operate the system; and 4) satisfaction. For the 9 veteran smokers that actually tried to use the Tobacco Tactics website to quit smoking, we were able to determine: 1) the number of times they signed onto the website; 2) the time spent on the website; and 3) the number of times each module was accessed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tobacco Tactics Website', 'description': 'Nine veteran smokers who will pilot test the Tobacco Tactics website\n\nTobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tobacco Tactics Website', 'description': 'Nine veteran smokers who will pilot test the Tobacco Tactics website\n\nTobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '63'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2008-04-22', 'resultsFirstSubmitDate': '2014-06-25', 'studyFirstSubmitQcDate': '2008-04-23', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-25', 'studyFirstPostDateStruct': {'date': '2008-04-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self Reported 30 Day Smoking Quit Rate', 'timeFrame': '30 days post intervention', 'description': 'Impact evaluation was the 30-day quit rates of the 9 veteran smokers that agreed to use the website.'}], 'secondaryOutcomes': [{'measure': 'Patient Feedback to Evaluate the Website', 'timeFrame': '30 days post intervention', 'description': 'Formative evaluation during pre-testing included qualitative feedback on the: 1) ability to accomplish tasks; 2) ability to accomplish goals with skill and speed; 3) ability to operate the system; and 4) satisfaction. For the 9 veteran smokers that actually tried to use the Tobacco Tactics website to quit smoking, we were able to determine: 1) the number of times they signed onto the website; 2) the time spent on the website; and 3) the number of times each module was accessed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking Cessation', 'Internet', 'Intervention Studies', 'Health Services Accessibility'], 'conditions': ['Smoking']}, 'referencesModule': {'references': [{'pmid': '23811612', 'type': 'RESULT', 'citation': 'Duffy SA, Fowler KE, Flanagan PS, Ronis DL, Ewing LA, Waltje AH. The development of the tobacco tactics website. JMIR Res Protoc. 2013 Jun 28;2(2):e22. doi: 10.2196/resprot.2445.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop an evidence-based Tobacco Tactics website tailored to veterans based on an intervention tested in the VA.', 'detailedDescription': 'Despite the detrimental effects of smoking, approximately 33% of veterans continue to smoke compared to approximately 21% of the general population. While efficacious cessation interventions are available, implementation of cessation interventions remains a challenge and new intervention strategies are needed to reach veterans. VA cessation providers recently met in Atlanta and one recommendation was to develop a cessation website for veterans. The evidence-based Tobacco Tactics website will be designed, pre-tested, and pilot tested as an intervention to assist veteran smokers to quit smoking. The efficacy of the website will then be tested in a subsequent randomized control trial (RCT). If the website proves efficacious, it would decrease morbidity and mortality among veterans, decrease face-to-face cessation intervention time for providers, and reach veterans in areas all over the country, perhaps through the VA "My Healthy Vet" website. This is a Phase 1 behavioral clinical trial designed to develop and pilot test a web-based Tobacco Tactics intervention tailored to veteran smokers. First, we will outline the specific content areas to be addressed. Second, we will develop the Tobacco Tactics intervention with our web designer in accordance with VA Web Operations. Third, a member of the research team will go through the website with the 5 veteran smokers obtaining feedback and noting any problems that occur. Fourth, with human studies approval, we will pilot test the impact of the intervention with 9 veteran smokers recruited to quit smoking using the Tobacco Tactics website. A research nurse will:\n\n1. be available by phone to answer any questions;\n2. collect qualitative data on veterans use of the Tobacco Tactics website; and,\n3. note the 30 day quit rate.\n\nFormative evaluation during pre-testing will include qualitative feedback on the:\n\n1. ability to accomplish tasks;\n2. ability to accomplish goals with skill and speed;\n3. ability to operate the system; and\n4. satisfaction.\n\nFor the 9 veteran smokers that actually try to use the Tobacco Tactics website to quit smoking, we will be able to determine:\n\n1. the number of times they signed onto the website;\n2. the time spent on the website; and\n3. the number of times each module was accessed.\n\nImpact evaluation will be the 30 day quit rates of the 9 veteran smokers that agree to use the website.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veteran,\n* Screen Positive for Current Smoking,\n* Greater than 18 Years of Age,\n* Access to the Internet\n\nExclusion Criteria:\n\n* Non-English Speaking,\n* Have Unstable Physical or Psychiatric/Mental Conditions'}, 'identificationModule': {'nctId': 'NCT00665704', 'briefTitle': 'Tobacco Tactics Website for Veteran Smokers', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Tobacco Tactics Website for Veteran Smokers', 'orgStudyIdInfo': {'id': 'SHP 08-197'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tobacco Tactics Website', 'description': 'Nine veteran smokers who will pilot test the Tobacco Tactics website', 'interventionNames': ['Behavioral: Tobacco Tactics website']}], 'interventions': [{'name': 'Tobacco Tactics website', 'type': 'BEHAVIORAL', 'description': 'Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers', 'armGroupLabels': ['Tobacco Tactics Website']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'VA Ann Arbor Healthcare System, Ann Arbor, MI', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Sonia A. Duffy, PhD MS RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, MI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}