Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-27 @ 9:32 PM
Study NCT ID:
NCT01412866
Status:
COMPLETED
Last Update Posted:
2018-12-12
First Post:
2011-08-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Electronic Decision Support Systems for Smokers With Severe Mental Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mary.f.brunette@dartmouth.edu', 'phone': '603-27105747', 'title': 'Mary F. Brunette', 'organization': 'DArtmouth-Hitchcock'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'EDSS With CO Monitor Feedback', 'description': 'Electronic decision support system with CO monitor feedback: Web-based electronic decision support system (EDSS) with carbon monoxide monitor and health-checklist', 'otherNumAtRisk': 58, 'otherNumAffected': 0, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'EDSS Without CO Monitor Feedback', 'description': 'Electronic decision support system without CO monitor feedback: Web-based electronic decision support system (EDSS) with health-checklist feedback alone', 'otherNumAtRisk': 66, 'otherNumAffected': 0, 'seriousNumAtRisk': 66, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Initiation of Smoking Cessation Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EDSS With CO Monitor Feedback', 'description': 'Electronic decision support system with CO monitor feedback: Web-based electronic decision support system (EDSS) with carbon monoxide monitor and health-checklist'}, {'id': 'OG001', 'title': 'EDSS Without CO Monitor Feedback', 'description': 'Electronic decision support system without CO monitor feedback: Web-based electronic decision support system (EDSS) with health-checklist feedback alone'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'df=1'}], 'paramType': 'NUMBER', 'timeFrame': '2 months', 'description': 'Started smoking cessation treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days of Nicotine Abstinence', 'timeFrame': '6 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EDSS With CO Monitor Feedback', 'description': 'Electronic decision support system with carbon monoxide (CO) monitor feedback: Web-based electronic decision support system (EDSS) with carbon monoxide monitor and health-checklist'}, {'id': 'FG001', 'title': 'EDSS Without CO Monitor Feedback', 'description': 'Electronic decision support system without carbon monoxide (CO) monitor feedback: Web-based electronic decision support system (EDSS) with health-checklist feedback alone'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'EDSS With CO Monitor Feedback', 'description': 'Electronic decision support system with CO monitor feedback: Web-based electronic decision support system (EDSS) with carbon monoxide monitor and health-checklist'}, {'id': 'BG001', 'title': 'EDSS Without CO Monitor Feedback', 'description': 'Electronic decision support system without CO monitor feedback: Web-based electronic decision support system (EDSS) with health-checklist feedback alone'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.7', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '46.3', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '46.5', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cigarettes smoked per day', 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '15.1', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '15.0', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Cigarettes', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-11', 'studyFirstSubmitDate': '2011-08-04', 'resultsFirstSubmitDate': '2014-03-13', 'studyFirstSubmitQcDate': '2011-08-08', 'lastUpdatePostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-11', 'studyFirstPostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initiation of Smoking Cessation Treatment', 'timeFrame': '2 months', 'description': 'Started smoking cessation treatment'}], 'secondaryOutcomes': [{'measure': 'Days of Nicotine Abstinence', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'severe mental illness', 'nicotine', 'smoking', 'motivation', 'electronic decision support system', 'motivational interviewing'], 'conditions': ['Severe Mental Illness', 'Nicotine Dependence', 'Schizophrenia', 'Tobacco Use Disorder']}, 'referencesModule': {'references': [{'pmid': '21459986', 'type': 'BACKGROUND', 'citation': 'Brunette MF, Ferron JC, McHugo GJ, Davis KE, Devitt TS, Wilkness SM, Drake RE. An electronic decision support system to motivate people with severe mental illnesses to quit smoking. Psychiatr Serv. 2011 Apr;62(4):360-6. doi: 10.1176/ps.62.4.pss6204_0360.'}, {'pmid': '26932324', 'type': 'DERIVED', 'citation': 'Ferron JC, Devitt T, McHugo GJ, A Jonikas J, Cook JA, Brunette MF. Abstinence and Use of Community-Based Cessation Treatment After a Motivational Intervention Among smokers with Severe Mental Illness. Community Ment Health J. 2016 May;52(4):446-56. doi: 10.1007/s10597-016-9998-1. Epub 2016 Mar 1.'}]}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial among SMI smokers assessed whether the EDSS with carbon monoxide monitor and health-checklist feedback lead to higher rates of initiation of smoking cessation treatment, days of smoking abstinence and Fagerstrom Dependence scores, compared to use of the EDSS with checklist feedback alone.', 'detailedDescription': 'Up to 80% of Americans with serious mental illnesses (SMI; schizophrenia and severe mood disorders) smoke cigarettes, and most suffer related health consequences. Although combined treatment with medication and psychosocial therapy can help people with SMI to quit smoking, it is rarely used. Motivational interventions can enhance the use of combined treatment, but motivational interventions are expensive and unavailable. To fill this gap, Dartmouth and Thresholds investigators have developed an easy-to-use, web-based electronic decision support system (EDSS) that aims to educate and motivate smokers with SMI. Preliminary testing has demonstrated excellent usability and increased engagement in smoking cessation treatments.\n\nOne critical issue is the use of personalized health feedback. Motivational interventions for smoking cessation for smokers with SMI, including our EDSS, have included personal feedback from a breath monitor that measures carbon monoxide, a toxic component of cigarette smoke. Feedback regarding carbon monoxide is thought to motivate the user by personalizing the health risks of smoking. The carbon monoxide monitor is, however, expensive, difficult to implement, and largely unavailable in public mental health and primary care clinics. Further, research on use of carbon monoxide monitoring in the general population is equivocal. Another motivational strategy to personalize the negative health effects of smoking is a health checklist with feedback. Health checklists have been shown to be effective, are easy to use, have no expense, but have not been assessed separately from carbon monoxide monitor feedback among SMI smokers. Testing the effect of feedback from the health checklist compared to feedback from the carbon monoxide monitor is an essential next step in the development of this tool.\n\nAim 1. The investigators propose a randomized clinical trial among SMI smokers to assess whether the EDSS with carbon monoxide monitor and health-checklist feedback will lead to higher rates of initiation of smoking cessation treatment than the EDSS with health-checklist feedback alone.\n\nAim 1.a. To explore whether use of the EDSS with carbon monoxide monitor and health-checklist feedback leads to higher rates of the distal outcomes, days of smoking abstinence and Fagerstrom Dependence scores, than use of the EDSS with checklist feedback alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult age 18-75\n* in treatment for severe mental illness,\n* current smoker,\n* physically able to use a computer\n\nExclusion Criteria:\n\n* Using smoking cessation treatment in past month,\n* substance dependence with current use'}, 'identificationModule': {'nctId': 'NCT01412866', 'briefTitle': 'Electronic Decision Support Systems for Smokers With Severe Mental Illness', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Electronic Decision Support Systems for Smokers With Severe Mental Illness', 'orgStudyIdInfo': {'id': 'EDSS1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EDSS with CO monitor', 'description': 'Web-based electronic decision support system (EDSS) with carbon monoxide (CO) monitor and health-checklist', 'interventionNames': ['Behavioral: EDSS with CO feedback and health checklist']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EDSS without CO monitor', 'description': 'Web-based electronic decision support system (EDSS) with health-checklist only', 'interventionNames': ['Behavioral: EDSS with health checklist feedback alon']}], 'interventions': [{'name': 'EDSS with CO feedback and health checklist', 'type': 'BEHAVIORAL', 'description': 'Web-based electronic decision support system with CO feedback and health-checklist', 'armGroupLabels': ['EDSS with CO monitor']}, {'name': 'EDSS with health checklist feedback alon', 'type': 'BEHAVIORAL', 'description': 'Web-based electronic decision support system (EDSS) with health-checklist feedback alone (without CO feedback)', 'armGroupLabels': ['EDSS without CO monitor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Thresholds Psychiatric Rehabilitation Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Mary F Brunette, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'U.S. Department of Education', 'class': 'FED'}, {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Mary F. Brunette, MD', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}