Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-05 @ 5:11 AM
Study NCT ID:
NCT03142932
Status:
COMPLETED
Last Update Posted:
2019-10-04
First Post:
2017-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
COach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jgolub@jhmi.edu', 'phone': '(443) 287-2969', 'title': 'Dr. Jonathan E. Golub', 'organization': 'Johns Hopkins University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limitations of the study include small sample size, short follow-up duration and large loss to follow-up. Self-reported measures could be subject to recall bias and social desirability bias. We also did not collect information on substance use.'}}, 'adverseEventsModule': {'timeFrame': '6 months (May - November 2017)', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': "A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model.\n\nCessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up.", 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'COach2Quit', 'description': "A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model.\n\nParticipants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application.\n\nIndividualized carbon monoxide (iCO) monitor: a personal monitor for a breath test for carbon monoxide (CO)\n\nCOach2Quit smartphone application: This smartphone application works in conjunction with the iCO monitor\n\nCessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up.", 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': "A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model.\n\nCessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."}, {'id': 'OG001', 'title': 'COach2Quit', 'description': "A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model.\n\nParticipants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application.\n\nIndividualized carbon monoxide (iCO) monitor: a personal monitor for a breath test for carbon monoxide (CO)\n\nCOach2Quit smartphone application: This smartphone application works in conjunction with the iCO monitor\n\nCessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."}], 'classes': [{'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000', 'lowerLimit': '14.0', 'upperLimit': '30.0'}, {'value': '23.0', 'groupId': 'OG001', 'lowerLimit': '18.0', 'upperLimit': '33.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline', 'description': 'A point of care test for measuring carbon monoxide (CO) will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 10ppm will indicate abstinence.', 'unitOfMeasure': 'parts per million', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Thirteen participants were lost to follow-up (9 at the 14-day visit and 4 at the 30-day visit) and the sample size for the analysis was 89. There were no significant differences in baseline characteristics between participants lost to follow-up and participants who completed the study.'}, {'type': 'PRIMARY', 'title': 'Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': "A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model.\n\nCessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."}, {'id': 'OG001', 'title': 'COach2Quit', 'description': "A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model.\n\nParticipants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application.\n\nIndividualized carbon monoxide (iCO) monitor: a personal monitor for a breath test for carbon monoxide (CO)\n\nCOach2Quit smartphone application: This smartphone application works in conjunction with the iCO monitor\n\nCessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."}], 'classes': [{'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '28.0'}, {'value': '19.5', 'groupId': 'OG001', 'lowerLimit': '15.0', 'upperLimit': '26.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 month', 'description': 'A point of care test for measuring carbon monoxide (CO) will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 10ppm will indicate abstinence.', 'unitOfMeasure': 'parts per million', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Thirteen participants were lost to follow-up (9 at the 14-day visit and 4 at the 30-day visit) and the sample size for the analysis was 89. There were no significant differences in baseline characteristics between participants lost to follow-up and participants who completed the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Color Change for Urine Test for Measuring Cotinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': "A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model.\n\nCessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."}, {'id': 'OG001', 'title': 'COach2Quit', 'description': "A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model.\n\nParticipants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application.\n\nIndividualized carbon monoxide (iCO) monitor: a personal monitor for a breath test for carbon monoxide (CO)\n\nCOach2Quit smartphone application: This smartphone application works in conjunction with the iCO monitor\n\nCessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."}], 'classes': [{'title': 'Normal / no change', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Light', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Heavy', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Very Heavy', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Missing/could not interpret', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline', 'description': 'A point of care urine test for measuring cotinine will also be conducted via the SmokeScreen® test from GFC Diagnostics Ltd. to verify smoking status. A color change to red/orange indicates a positive sample, with a darker color indicating greater nicotine intake.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Thirteen participants were lost to follow-up (9 at the 14-day visit and 4 at the 30-day visit) and the sample size for the analysis was 89. There were no significant differences in baseline characteristics between participants lost to follow-up and participants who completed the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Color Change for Urine Test for Measuring Cotinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': "A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model.\n\nCessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."}, {'id': 'OG001', 'title': 'COach2Quit', 'description': "A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model.\n\nParticipants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application.\n\nIndividualized carbon monoxide (iCO) monitor: a personal monitor for a breath test for carbon monoxide (CO)\n\nCOach2Quit smartphone application: This smartphone application works in conjunction with the iCO monitor\n\nCessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."}], 'classes': [{'title': 'Normal / no change', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Light', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Heavy', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Very Heavy', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Missing/could not interpret', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'A point of care urine test for measuring cotinine will also be conducted via the SmokeScreen® test from GFC Diagnostics Ltd. to verify smoking status. A color change to red/orange indicates a positive sample, with a darker color indicating greater nicotine intake.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Thirteen participants were lost to follow-up (9 at the 14-day visit and 4 at the 30-day visit) and the sample size for the analysis was 89. There were no significant differences in baseline characteristics between participants lost to follow-up and participants who completed the study.'}, {'type': 'SECONDARY', 'title': 'Reasons for Quitting Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': "A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model.\n\nCessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."}, {'id': 'OG001', 'title': 'COach2Quit', 'description': "A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model.\n\nParticipants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application.\n\nIndividualized carbon monoxide (iCO) monitor: a personal monitor for a breath test for carbon monoxide (CO)\n\nCOach2Quit smartphone application: This smartphone application works in conjunction with the iCO monitor\n\nCessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '2.8'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '2.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': "We used the Reasons for Quitting (RFQ) scale to measure motivation to quit smoking. The scale is used to measure intrinsic and extrinsic motivation for quitting smoking. Each item in the scale is evaluated using a 5-point Likert scale regarding how true the statement is about the participant's motivation to quit smoking (Not at all true, a little bit true, moderately true, quite true, extremely true). Each option takes on a numerical score from 0 (not at all true) to 4 (extremely true). Scores are summed across all items in the scale and divided by the number of items in the scale to obtain the RFQ score. The range of possible scores is 0 to 4. A higher score indicates greater motivation to quit smoking.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Thirteen participants were lost to follow-up (9 at the 14-day visit and 4 at the 30-day visit) and the sample size for the analysis was 89. There were no significant differences in baseline characteristics between participants lost to follow-up and participants who completed the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': "A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model.\n\nCessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."}, {'id': 'FG001', 'title': 'COach2Quit', 'description': "A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model.\n\nParticipants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application.\n\nIndividualized carbon monoxide (iCO) monitor: a personal monitor for a breath test for carbon monoxide (CO)\n\nCOach2Quit smartphone application: This smartphone application works in conjunction with the iCO monitor\n\nCessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}], 'recruitmentDetails': 'Participants were recruited through posters advertising the study around the Johns Hopkins Medical Institutions East Baltimore campus, including clinics, inpatient and outpatient facilities, and through participant referrals.', 'preAssignmentDetails': '160 participants were assessed for eligibility, 58 did not meet inclusion criteria'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': "A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model.\n\nCessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."}, {'id': 'BG001', 'title': 'COach2Quit', 'description': "A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model.\n\nParticipants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application.\n\nIndividualized carbon monoxide (iCO) monitor: a personal monitor for a breath test for carbon monoxide (CO)\n\nCOach2Quit smartphone application: This smartphone application works in conjunction with the iCO monitor\n\nCessation counseling: The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000', 'lowerLimit': '41', 'upperLimit': '55'}, {'value': '52', 'groupId': 'BG001', 'lowerLimit': '47', 'upperLimit': '56'}, {'value': '52', 'groupId': 'BG002', 'lowerLimit': '45', 'upperLimit': '56'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}, {'title': 'Mixed Race/Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education', 'classes': [{'title': 'Less than high school', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'High school or more', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment', 'classes': [{'title': 'Employed (full/part time)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': "Unemployed/don't work", 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cigarettes smoked per day', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000', 'lowerLimit': '9', 'upperLimit': '20'}, {'value': '10', 'groupId': 'BG001', 'lowerLimit': '7', 'upperLimit': '20'}, {'value': '10', 'groupId': 'BG002', 'lowerLimit': '8', 'upperLimit': '20'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cigarettes', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Quit attempts in past 12 months', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '2'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'attempts', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Fagerström Test for Nicotine Dependence', 'classes': [{'categories': [{'measurements': [{'value': '2.85', 'spread': '1.51', 'groupId': 'BG000'}, {'value': '2.54', 'spread': '1.43', 'groupId': 'BG001'}, {'value': '2.69', 'spread': '1.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'We used the Fagerstrom Test for Nicotine Dependence (FTND) to measure nicotine dependence.\n\nThe measure consists of 6 Questions. Each question has multiple response options out of which one option must be selected. Each option carries a corresponding numerical score. The scores for each question are summed to obtain a total score. The range of possible scores is 1 to 10, with a higher value indicating greater nicotine dependence (worse outcome).\n\nThe interpretation of scores is as follows:\n\n1-2: low dependence 3-4: low to moderate dependence 5-7: moderate dependence 8+: high dependence', 'unitOfMeasure': 'score', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-15', 'size': 1025585, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-08-23T12:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-02', 'studyFirstSubmitDate': '2017-04-28', 'resultsFirstSubmitDate': '2018-08-23', 'studyFirstSubmitQcDate': '2017-05-03', 'lastUpdatePostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-29', 'studyFirstPostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)', 'timeFrame': 'baseline', 'description': 'A point of care test for measuring carbon monoxide (CO) will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 10ppm will indicate abstinence.'}, {'measure': 'Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)', 'timeFrame': '1 month', 'description': 'A point of care test for measuring carbon monoxide (CO) will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 10ppm will indicate abstinence.'}, {'measure': 'Number of Participants With Color Change for Urine Test for Measuring Cotinine', 'timeFrame': 'baseline', 'description': 'A point of care urine test for measuring cotinine will also be conducted via the SmokeScreen® test from GFC Diagnostics Ltd. to verify smoking status. A color change to red/orange indicates a positive sample, with a darker color indicating greater nicotine intake.'}, {'measure': 'Number of Participants With Color Change for Urine Test for Measuring Cotinine', 'timeFrame': '1 month', 'description': 'A point of care urine test for measuring cotinine will also be conducted via the SmokeScreen® test from GFC Diagnostics Ltd. to verify smoking status. A color change to red/orange indicates a positive sample, with a darker color indicating greater nicotine intake.'}], 'secondaryOutcomes': [{'measure': 'Reasons for Quitting Scale', 'timeFrame': 'baseline', 'description': "We used the Reasons for Quitting (RFQ) scale to measure motivation to quit smoking. The scale is used to measure intrinsic and extrinsic motivation for quitting smoking. Each item in the scale is evaluated using a 5-point Likert scale regarding how true the statement is about the participant's motivation to quit smoking (Not at all true, a little bit true, moderately true, quite true, extremely true). Each option takes on a numerical score from 0 (not at all true) to 4 (extremely true). Scores are summed across all items in the scale and divided by the number of items in the scale to obtain the RFQ score. The range of possible scores is 0 to 4. A higher score indicates greater motivation to quit smoking."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['smoking'], 'conditions': ['Smoking', 'Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to conduct a randomized controlled trial to determine whether the use of the COach2Quit application (app) reduces smoking more than brief advice for smoking cessation. The investigators hypothesize that real time biomarker feedback and messaging support from the COach2Quit app will lead to greater smoking cessation rates than brief anti-smoking advice alone. If effective, the COach2Quit app could be an easily accessible and cost-effective tool to help smokers quit. The findings from this trial could have implications for the delivery of future outpatient smoking cessation programs.', 'detailedDescription': 'The goal of this randomized controlled trial is to assess the efficacy of the novel COach2Quit smartphone application by determining whether the use of this app reduces smoking more than brief anti-smoking advice alone. This will be a two-arm individually randomized trial and participants who are currently smoking will be assigned 1:1 to either study arm. Smoking behavior will be measured through self-report at baseline, 2-week and 1-month follow up visits. Smoking behavior will also be verified by 2 biomarker measurements: carbon monoxide breath test and urine cotinine, collected at baseline, 2-week and 1-month follow-up visits. In addition, participants will receive weekly follow-up calls. The primary outcome will be smoking cessation at the 1-month follow-up visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years of age\n* current, daily smokers\n* agree to participate and anticipate to be living in Baltimore for at least 2 months\n* own a phone that is compatible with the app\n* be willing to set at baseline assessment a quit date within 2 weeks\n\nExclusion Criteria:\n\n* are suffering from any unstable medical condition precluding the use of the CO monitor (e.g. severe COPD)\n* are currently using smokeless tobacco including e-cigarettes\n* are currently using nicotine replacement therapy or other smoking cessation treatment\n* are pregnant, determined by participant self-report\n* have a negative baseline result on both urine cotinine AND CO monitor'}, 'identificationModule': {'nctId': 'NCT03142932', 'acronym': 'C2Q', 'briefTitle': 'COach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'COach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation', 'orgStudyIdInfo': {'id': 'IRB00124820'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': "A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model.", 'interventionNames': ['Behavioral: Cessation counseling']}, {'type': 'EXPERIMENTAL', 'label': 'COach2Quit', 'description': "A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model.\n\nParticipants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application.", 'interventionNames': ['Device: Individualized carbon monoxide (iCO) monitor', 'Other: COach2Quit smartphone application', 'Behavioral: Cessation counseling']}], 'interventions': [{'name': 'Individualized carbon monoxide (iCO) monitor', 'type': 'DEVICE', 'description': 'a personal monitor for a breath test for carbon monoxide (CO)', 'armGroupLabels': ['COach2Quit']}, {'name': 'COach2Quit smartphone application', 'type': 'OTHER', 'description': 'This smartphone application works in conjunction with the iCO monitor', 'armGroupLabels': ['COach2Quit']}, {'name': 'Cessation counseling', 'type': 'BEHAVIORAL', 'description': "The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up.", 'armGroupLabels': ['COach2Quit', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Jonathan E Golub, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maryland Department of Health and Mental Hygiene', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}