Viewing Study NCT01065493


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Study NCT ID: NCT01065493
Status: UNKNOWN
Last Update Posted: 2014-11-19
First Post: 2010-02-08
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: QuitAdvisorMD: A Point-of-care Tool for Brief Smoking Cessation Interventions
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-18', 'studyFirstSubmitDate': '2010-02-08', 'studyFirstSubmitQcDate': '2010-02-08', 'lastUpdatePostDateStruct': {'date': '2014-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The goal of the evaluation is to assess the ability of QuitAdvisorMD to influence smoking cessation as measured by the primary outcome of the increase in physician initiated smoking cessation counseling.', 'timeFrame': '12 Months'}], 'secondaryOutcomes': [{'measure': 'Secondary outcomes will include, 1) the increase in ability of clinicians to provide appropriate stage-based smoking cessation assistance, and 2) the increase in patient quit attempts.', 'timeFrame': '12 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Smoking', 'Tobacco Use Disorder']}, 'descriptionModule': {'briefSummary': "QuitAdvisorMD: A point-of-care tool for brief smoking cessation interventions Under a Phase II SBIR grant supported by NIH/NIDA, we are developing QUITAdvisorMD: a point-of-care, patient-centered resource for counseling patients who smoke or use tobacco products. It is based on the principles of Motivational Interviewing, a non-confrontational and very effective method for intervening and treating these patients; the 5 A's of behavioral interventions; and the Transtheoretical Model of Change. Through a point and click interface, the tool uses a series of interview questions designed to motivate patients to stop smoking by first assessing their stage of change and then offering effective stage-based interventions and interview techniques. The tool also offers stage-tailored patient information, a clinician educational reference, and the ability to communicate support information patients via email and/or text message."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any physician providing care for members of Southern Health through primary care and have access to a point-of-care computing device (Smartphone, desktop PC, etc) during patient visits.\n\nExclusion Criteria:\n\n* Lack of appropriate computing device'}, 'identificationModule': {'nctId': 'NCT01065493', 'briefTitle': 'QuitAdvisorMD: A Point-of-care Tool for Brief Smoking Cessation Interventions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Silverchair Science & Communications, LLC'}, 'officialTitle': 'QuitAdvisorMD: A Point-of-care Tool for Brief Smoking Cessation Interventions', 'orgStudyIdInfo': {'id': 'R44DA026682', 'link': 'https://reporter.nih.gov/quickSearch/R44DA026682', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R44DA026682', 'link': 'https://reporter.nih.gov/quickSearch/R44DA026682', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Software Assisted Lifestyle Counseling', 'interventionNames': ['Other: QuitAdvisorMD Software Algorithm']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lifestyle Counseling', 'description': 'Status quo smoking cessation counseling.', 'interventionNames': ['Behavioral: Standard Smoking Cessation Counseling']}], 'interventions': [{'name': 'QuitAdvisorMD Software Algorithm', 'type': 'OTHER', 'description': 'QuitAdvisorMD, a set of brief clinical assessments, counseling scripts and intervention instruments for smoking cessation in primary care settings', 'armGroupLabels': ['Software Assisted Lifestyle Counseling']}, {'name': 'Standard Smoking Cessation Counseling', 'type': 'BEHAVIORAL', 'description': 'Standard Smoking Cessation Counseling', 'armGroupLabels': ['Lifestyle Counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'George Reynolds, BA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Silverchair, Inc'}, {'name': 'Scott Strayer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Silverchair Science & Communications, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}