Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-02-22 @ 6:45 PM
Study NCT ID:
NCT05327660
Status:
COMPLETED
Last Update Posted:
2024-10-28
First Post:
2022-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CO Monitoring for Tobacco Cessation in Quitlines
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D020340', 'term': 'Tobacco Use Cessation'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kmullis@rvohealth.com', 'phone': '765-265-9169', 'title': 'Dr. Kristina Mullis', 'organization': 'Consumer Wellness Solutions/RVO Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for 8 months, from the start of recruitment through the final outcome survey collection.', 'eventGroups': [{'id': 'EG000', 'title': 'Quitline Treatment as Usual (TAU)', 'description': 'Quitline services provided by participating state quitlines\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 0, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Quitline TAU Plus Remote CO Monitoring', 'description': 'Quitline service plus daily CO monitoring via a smartphone app\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).\n\nRemote Carbon Monoxide (CO) Monitoring: Remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor.', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 0, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Quitline TAU Plus Incentivized Remote CO Monitoring', 'description': 'Quitline TAU plus remote CO monitoring with small monetary incentives\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).\n\nIncentivized Remote CO Monitoring: Incentivized remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor and delivers small monetary incentives for each use of the CO monitor.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Quitline Treatment as Usual (TAU)', 'description': 'Quitline services provided by participating state quitlines\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).'}, {'id': 'OG001', 'title': 'Quitline TAU Plus Remote CO Monitoring', 'description': 'Quitline service plus daily CO monitoring via a smartphone app\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).\n\nRemote Carbon Monoxide (CO) Monitoring: Remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor.'}, {'id': 'OG002', 'title': 'Quitline TAU Plus Incentivized Remote CO Monitoring', 'description': 'Quitline TAU plus remote CO monitoring with small monetary incentives\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).\n\nIncentivized Remote CO Monitoring: Incentivized remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor and delivers small monetary incentives for each use of the CO monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 days', 'description': 'Rating of satisfaction with quitline services on a 6-point scale collected via follow-up survey. Five questions were internally developed to determine satisfaction with the quitline services provided where low numbers (1-3) mean dissatisfaction and high numbers (4-6) mean satisfaction. Participants that reported a score of 4 (somewhat satisfied) or more are represented in the data table.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Treatment Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Quitline Treatment as Usual (TAU)', 'description': 'Quitline services provided by participating state quitlines\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).'}, {'id': 'OG001', 'title': 'Quitline TAU Plus Remote CO Monitoring', 'description': 'Quitline service plus daily CO monitoring via a smartphone app\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).\n\nRemote Carbon Monoxide (CO) Monitoring: Remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor.'}, {'id': 'OG002', 'title': 'Quitline TAU Plus Incentivized Remote CO Monitoring', 'description': 'Quitline TAU plus remote CO monitoring with small monetary incentives\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).\n\nIncentivized Remote CO Monitoring: Incentivized remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor and delivers small monetary incentives for each use of the CO monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '1.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 days', 'description': 'Number of quitline calls each participant engages in, collected via clinical record system.', 'unitOfMeasure': 'Calls completed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Self-reported Tobacco Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Quitline Treatment as Usual (TAU)', 'description': 'Quitline services provided by participating state quitlines\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).'}, {'id': 'OG001', 'title': 'Quitline TAU Plus Remote CO Monitoring', 'description': 'Quitline service plus daily CO monitoring via a smartphone app\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).\n\nRemote Carbon Monoxide (CO) Monitoring: Remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor.'}, {'id': 'OG002', 'title': 'Quitline TAU Plus Incentivized Remote CO Monitoring', 'description': 'Quitline TAU plus remote CO monitoring with small monetary incentives\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).\n\nIncentivized Remote CO Monitoring: Incentivized remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor and delivers small monetary incentives for each use of the CO monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 days', 'description': '7 day point prevalence abstinence from all combustible tobacco collected via follow-up survey', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Biochemically Verified Tobacco Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Quitline Treatment as Usual (TAU)', 'description': 'Quitline services provided by participating state quitlines\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).'}, {'id': 'OG001', 'title': 'Quitline TAU Plus Remote CO Monitoring', 'description': 'Quitline service plus daily CO monitoring via a smartphone app\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).\n\nRemote Carbon Monoxide (CO) Monitoring: Remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor.'}, {'id': 'OG002', 'title': 'Quitline TAU Plus Incentivized Remote CO Monitoring', 'description': 'Quitline TAU plus remote CO monitoring with small monetary incentives\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).\n\nIncentivized Remote CO Monitoring: Incentivized remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor and delivers small monetary incentives for each use of the CO monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 days', 'description': 'CO monitor reading 60 days post randomization (must be 7ppm or less to be considered abstinent) collected via smartphone app', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Engagement With CO Monitor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Quitline Treatment as Usual (TAU)', 'description': 'Quitline services provided by participating state quitlines\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).'}, {'id': 'OG001', 'title': 'Quitline TAU Plus Remote CO Monitoring', 'description': 'Quitline service plus daily CO monitoring via a smartphone app\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).\n\nRemote Carbon Monoxide (CO) Monitoring: Remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor.'}, {'id': 'OG002', 'title': 'Quitline TAU Plus Incentivized Remote CO Monitoring', 'description': 'Quitline TAU plus remote CO monitoring with small monetary incentives\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).\n\nIncentivized Remote CO Monitoring: Incentivized remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor and delivers small monetary incentives for each use of the CO monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '54.8', 'spread': '49.6', 'groupId': 'OG001'}, {'value': '80.9', 'spread': '48.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 days', 'description': 'Number of times remote CO monitor is used collected via smartphone app.', 'unitOfMeasure': 'Breath tests completed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Satisfaction With CO Monitor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Quitline Treatment as Usual (TAU)', 'description': 'Quitline services provided by participating state quitlines\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).'}, {'id': 'OG001', 'title': 'Quitline TAU Plus Remote CO Monitoring', 'description': 'Quitline service plus daily CO monitoring via a smartphone app\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).\n\nRemote Carbon Monoxide (CO) Monitoring: Remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor.'}, {'id': 'OG002', 'title': 'Quitline TAU Plus Incentivized Remote CO Monitoring', 'description': 'Quitline TAU plus remote CO monitoring with small monetary incentives\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).\n\nIncentivized Remote CO Monitoring: Incentivized remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor and delivers small monetary incentives for each use of the CO monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 days', 'description': 'Satisfaction with CO monitor measures on a 6-point scale collected via follow-up survey. Five questions were internally developed to determine satisfaction with the CO monitor device and app where low numbers (1-3) mean dissatisfaction and high numbers (4-6) mean satisfaction. Participants that reported a score of 4 (somewhat satisfied) or more are represented in the data table.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Quitline Treatment as Usual (TAU)', 'description': 'Quitline services provided by participating state quitlines\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).'}, {'id': 'FG001', 'title': 'Quitline TAU Plus Remote CO Monitoring', 'description': 'Quitline service plus daily CO monitoring via a smartphone app\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).\n\nRemote Carbon Monoxide (CO) Monitoring: Remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor.'}, {'id': 'FG002', 'title': 'Quitline TAU Plus Incentivized Remote CO Monitoring', 'description': 'Quitline TAU plus remote CO monitoring with small monetary incentives\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).\n\nIncentivized Remote CO Monitoring: Incentivized remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor and delivers small monetary incentives for each use of the CO monitor.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '76'}, {'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '76'}, {'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '229', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Quitline Treatment as Usual (TAU)', 'description': 'Quitline services provided by participating state quitlines\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).'}, {'id': 'BG001', 'title': 'Quitline TAU Plus Remote CO Monitoring', 'description': 'Quitline service plus daily CO monitoring via a smartphone app\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).\n\nRemote Carbon Monoxide (CO) Monitoring: Remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor.'}, {'id': 'BG002', 'title': 'Quitline TAU Plus Incentivized Remote CO Monitoring', 'description': 'Quitline TAU plus remote CO monitoring with small monetary incentives\n\nQuitline Treatment as Usual (TAU): Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).\n\nIncentivized Remote CO Monitoring: Incentivized remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor and delivers small monetary incentives for each use of the CO monitor.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.3', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '54.5', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '55.5', 'spread': '11.1', 'groupId': 'BG002'}, {'value': '54.5', 'spread': '11.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '212', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '229', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-19', 'size': 393175, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-20T13:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 229}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-24', 'studyFirstSubmitDate': '2022-04-06', 'resultsFirstSubmitDate': '2024-03-20', 'studyFirstSubmitQcDate': '2022-04-06', 'lastUpdatePostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-24', 'studyFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Satisfaction', 'timeFrame': '60 days', 'description': 'Rating of satisfaction with quitline services on a 6-point scale collected via follow-up survey. Five questions were internally developed to determine satisfaction with the quitline services provided where low numbers (1-3) mean dissatisfaction and high numbers (4-6) mean satisfaction. Participants that reported a score of 4 (somewhat satisfied) or more are represented in the data table.'}, {'measure': 'Treatment Engagement', 'timeFrame': '60 days', 'description': 'Number of quitline calls each participant engages in, collected via clinical record system.'}, {'measure': 'Self-reported Tobacco Abstinence', 'timeFrame': '60 days', 'description': '7 day point prevalence abstinence from all combustible tobacco collected via follow-up survey'}], 'secondaryOutcomes': [{'measure': 'Biochemically Verified Tobacco Abstinence', 'timeFrame': '60 days', 'description': 'CO monitor reading 60 days post randomization (must be 7ppm or less to be considered abstinent) collected via smartphone app'}, {'measure': 'Engagement With CO Monitor', 'timeFrame': '60 days', 'description': 'Number of times remote CO monitor is used collected via smartphone app.'}, {'measure': 'Satisfaction With CO Monitor', 'timeFrame': '60 days', 'description': 'Satisfaction with CO monitor measures on a 6-point scale collected via follow-up survey. Five questions were internally developed to determine satisfaction with the CO monitor device and app where low numbers (1-3) mean dissatisfaction and high numbers (4-6) mean satisfaction. Participants that reported a score of 4 (somewhat satisfied) or more are represented in the data table.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tobacco cessation', 'tobacco quitlines', 'carbon monoxide monitoring', 'incentives'], 'conditions': ['Tobacco Dependence']}, 'descriptionModule': {'briefSummary': 'The present study is a 3-arm randomized controlled pilot study. Participants who call the Maryland Tobacco Quitline and are eligible for study participation are randomized to receive quitline tobacco cessation treatment as usual (TAU), TAU plus remote carbon monoxide (CO) monitoring via smartphone app, or TAU plus remote carbon monoxide monitoring plus incentives vis smartphone app. The investigators hypothesize that remote CO monitoring will be feasible and acceptable to deliver in the quitline setting, will increase treatment engagement, and will increase tobacco cessation and treatment satisfaction rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Daily cigarette smokers calling into participating quitlines\n* 18 year or older\n* Reads and speaks English\n* Has a smartphone with a data plan\n* Willing to download and use study app\n* Willing to use CO monitor\n\nExclusion Criteria:\n\n• Pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT05327660', 'briefTitle': 'CO Monitoring for Tobacco Cessation in Quitlines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Consumer Wellness Solutions'}, 'officialTitle': 'Remote Carbon Monoxide Monitoring and Incentives for Tobacco Cessation in Quitlines', 'orgStudyIdInfo': {'id': '2021-0056'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Quitline treatment as usual (TAU)', 'description': 'Quitline services provided by participating state quitlines', 'interventionNames': ['Combination Product: Quitline Treatment as Usual (TAU)']}, {'type': 'EXPERIMENTAL', 'label': 'Quitline TAU plus remote CO monitoring', 'description': 'Quitline service plus daily CO monitoring via a smartphone app', 'interventionNames': ['Combination Product: Quitline Treatment as Usual (TAU)', 'Combination Product: Remote Carbon Monoxide (CO) Monitoring']}, {'type': 'EXPERIMENTAL', 'label': 'Quitline TAU plus incentivized remote CO monitoring', 'description': 'Quitline TAU plus remote CO monitoring with small monetary incentives', 'interventionNames': ['Combination Product: Quitline Treatment as Usual (TAU)', 'Combination Product: Incentivized Remote CO Monitoring']}], 'interventions': [{'name': 'Quitline Treatment as Usual (TAU)', 'type': 'COMBINATION_PRODUCT', 'description': 'Quitline TAU is services provided by the state quitline and includes phone coaching, nicotine replacement, supplemental materials (e.g., text messaging, online content).', 'armGroupLabels': ['Quitline TAU plus incentivized remote CO monitoring', 'Quitline TAU plus remote CO monitoring', 'Quitline treatment as usual (TAU)']}, {'name': 'Remote Carbon Monoxide (CO) Monitoring', 'type': 'COMBINATION_PRODUCT', 'description': 'Remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor.', 'armGroupLabels': ['Quitline TAU plus remote CO monitoring']}, {'name': 'Incentivized Remote CO Monitoring', 'type': 'COMBINATION_PRODUCT', 'description': 'Incentivized remote CO monitoring includes a smartphone app and a remote carbon monoxide monitor. The app tracks and prompts daily use of the CO monitor and delivers small monetary incentives for each use of the CO monitor.', 'armGroupLabels': ['Quitline TAU plus incentivized remote CO monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98125', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Optum Center for Wellbeing Research', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Kelly Carpenter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consumer Wellness Solutions'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Consumer Wellness Solutions', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Vincere Health', 'class': 'INDUSTRY'}, {'name': 'Maryland State Tobacco Quitline', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}