Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2026-01-04 @ 3:56 AM
Study NCT ID:
NCT04560868
Status:
COMPLETED
Last Update Posted:
2023-01-23
First Post:
2020-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Development of a mHealth Intervention for Ambivalent Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D012907', 'term': 'Smoking'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jennifer.b.mcclure@kp.org', 'phone': '206-287-2737', 'title': 'Director, Investigative Science', 'organization': 'Kaiser Permanente Washington Health Research Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The purpose of this pilot was to inform feasibility and acceptability of the experimental app among smokers who were ambivalent about quitting. Data were analyzed among participants who installed the app (n = 57). This pilot study was not powered to provide definitive answers about the efficacy of the intervention in promoting smoking abstinence. A larger trial is needed for this.'}}, 'adverseEventsModule': {'timeFrame': "For each participant, adverse events (AE's) were collected over a 3 month period, starting at baseline and ending at 3-month follow-up. Events were monitored continually during this period.", 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Program Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '19.9', 'spread': '16.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.73', 'ciLowerLimit': '6.41', 'ciUpperLimit': '19.05', 'estimateComment': 'mean difference=experimental-control', 'groupDescription': 'Based on a priori power calculations we had 80% power to detect an average increase of 3.8 log ins in the experimental relative to the control arm.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The point null hypothesis was a difference in expected number of log ins of exactly 0.'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at 3-month follow-up', 'description': 'Number of unique app user-sessions', 'unitOfMeasure': 'User sessions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All individuals who installed the app (n = 57).'}, {'type': 'PRIMARY', 'title': 'Quit Attempt Lasting at Least 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.98', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.85', 'estimateComment': 'relative risk=experimental/control', 'groupDescription': 'Based on a priori power calculations, we had 80% power to detect a 33% - 35% increase in the proportion of experimental participants who successfully quit smoking for at least 24 hours relative to controls.', 'statisticalMethod': 'Regression, Poisson', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was a point null of relative risk equal to exactly 1.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed at 3-month follow-up', 'description': 'At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All individuals who installed the app (n = 57).'}, {'type': 'PRIMARY', 'title': 'Not Smoking (Even a Puff) in the Last 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.24', 'estimateComment': 'Risk difference = experimental - control.', 'groupDescription': 'Based on a priori power calculations, we had 80% power to detect a 28% - 33% increase in 7-day smoking abstinence in the experimental arm relative to the control arm at 3 months.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was a point null of exactly 0 risk difference between arms.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed at 3-month follow-up', 'description': '7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All individuals who installed the app (n = 57).'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Assigned App', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.40', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.87', 'estimateComment': 'mean difference=experimental-control', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was a point null of exactly 0 difference in expected score between arms.'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at 1 month', 'description': 'Satisfaction with the overall "content and advice" of the assigned app, rated on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Responses were assessed among participants who earned at least one utilization badge by the one-month survey. This ensured participants had sufficient interaction with the app to rate their satisfaction with it.'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Assigned App', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '0.60', 'estimateComment': 'mean difference=experimental-control', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was a point null of exactly 0 difference in expected score between arms.'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at 3 months', 'description': 'Satisfaction with the overall "content and advice" of the assigned app on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Responses were assessed among participants who earned at least one utilization badge by the three-month survey. This was done to ensure participants had sufficient interaction with the app to rate their satisfaction with it.'}, {'type': 'SECONDARY', 'title': 'Helpfulness of Assigned App', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '1.4', 'estimateComment': 'mean difference=experimental-control', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The tested hypothesis was a point null of 0 difference in expected average helpfulness score between arms.'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at 1 month.', 'description': 'Global helpfulness rating calculated as the average helpfulness rating of 8 app features, each rated on a Likert scale from 1="not at all helpful" to 5="extremely helpful".', 'unitOfMeasure': 'average scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who installed the app, self-reported use of all rated features, rated each feature on follow-up survey, and were confirmed via automated data to have used the app features.'}, {'type': 'SECONDARY', 'title': 'Helpfulness of Assigned App', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '1.3', 'estimateComment': 'mean difference=experimental-control', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The tested hypothesis was for a point null of 0 difference in expected average helpfulness score between arms.'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at 3 months', 'description': 'Average helpfulness rating of 8 separate app features, with each feature rated on a Likert scale from 1="not at all helpful" to 5="extremely helpful".', 'unitOfMeasure': 'average scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals who installed the app, responded to questions about helpfulness of each rated feature, self-reported use of each app feature, and based on automated data had sufficient use of the app features to rate their helpfulness at follow-up.'}, {'type': 'SECONDARY', 'title': 'Program Engagement - Earned Badges', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '5.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at 1-month follow-up', 'description': 'Number of accumulated badge rewards earned from using the assigned app.', 'unitOfMeasure': 'badges', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All individuals who installed the app (n = 57).'}, {'type': 'SECONDARY', 'title': 'Program Engagement - Earned Badges', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '6.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.2', 'ciLowerLimit': '1.72', 'ciUpperLimit': '6.65', 'estimateComment': 'mean difference=experimental-control', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was a point null of exactly 0 difference in expected number of badges earned in each arm by 3 months post-baseline.'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at 3-month follow-up', 'description': 'Number of accumulated badge rewards earned from using the assigned app.', 'unitOfMeasure': 'Badges', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all individuals who installed the app. Everyone used the app at least once.'}, {'type': 'SECONDARY', 'title': 'Self-efficacy to Quit Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.96', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-1.02', 'ciUpperLimit': '1.18', 'estimateComment': 'mean difference=experimental-control', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was a point null of exactly 0 difference in expected score between arms.'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at 1 month', 'description': 'Self-reported confidence in quitting smoking on Likert scale from 1="not at all" to 10="extremely".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Respondents to the assessed question, which was only asked to those still smoking at follow-up and had installed the app.'}, {'type': 'SECONDARY', 'title': 'Self-efficacy to Quit Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.31', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '0.66', 'estimateComment': 'mean difference=experimental-control', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was a point null hypothesis of exactly 0 difference in expected score between the arms.'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at 3 months', 'description': 'Self-reported confidence in quitting smoking on a Likert scale from 1="not at all" to 10="extremely".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Respondents to the assessed question, which was only asked among individuals who were still smoking at follow-up and had installed the app.'}, {'type': 'SECONDARY', 'title': 'Self-efficacy to Stay Quit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'spread': 'NA', 'comment': 'The Overall Number of Participants Analyzed is 1, so the Standard Deviation was not calculated.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at 1 month', 'description': 'Self-reported confidence in ability to stay quit on a Likert scale from 1="not at all" to 10="extremely".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Respondents to a question only asked among participants who installed the app and reported they had not smoked in the past 7 days.'}, {'type': 'SECONDARY', 'title': 'Self-efficacy to Stay Quit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'spread': 'NA', 'comment': 'The Overall Number of Participants Analyzed is 1, so the Standard Deviation was not calculated.', 'groupId': 'OG000'}, {'value': '9', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at 3 months', 'description': 'Self-reported confidence in ability to stay quit (if no smoking in the past 7 days) on a Likert scale from 1="not at all" to 10="extremely".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Respondents to question asked among individuals who installed the app and reported not smoking in the past 7 days at 3 month follow-up.'}, {'type': 'SECONDARY', 'title': 'Earned and Requested Free Nicotine Replacement Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed at 1-month follow-up', 'description': 'Earned and requested free nicotine replacement therapy (NRT); free NRT could be earned by earning 6 app utilization badges.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All individuals who installed the app (n = 57).'}, {'type': 'SECONDARY', 'title': 'Earned and Requested Free Nicotine Replacement Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.9', 'ciLowerLimit': '0.9', 'ciUpperLimit': '16.9', 'estimateComment': 'RR=experimental/control', 'statisticalMethod': 'Regression, Poisson', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The point null hypothesis was of the exact same proportion of control and experimental subjects requesting NRT.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed at 3-month follow-up', 'description': 'Earned and requested free nicotine replacement therapy (NRT); free NRT could be earned by earning 6 app utilization badges.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals who installed the app (n = 57). Note that free NRT is earned when 6 utilization badges have been earned.'}, {'type': 'SECONDARY', 'title': 'Quit Attempt Lasting at Least 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.38', 'ciUpperLimit': '2.65', 'estimateComment': 'risk ratio=experimental/control', 'statisticalMethod': 'Regression, Poisson', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was a point null of exactly 0 difference in probability of the outcome between arms.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed at 1 month follow-up', 'description': 'At least one intentional smoking quit attempt lasting at least 24 hours; non-respondents were assumed to not have a successful quit attempt.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals who installed the app (n = 57).'}, {'type': 'SECONDARY', 'title': 'Change in Cigarettes/Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}], 'classes': [{'title': 'Baseline 30-day average cigarettes/day', 'categories': [{'measurements': [{'value': '17.9', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '8.2', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in number of cigarettes/day at 1 month (using one-month 7-day average)', 'categories': [{'measurements': [{'value': '-5.1', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '4.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.39', 'ciLowerLimit': '-1.21', 'ciUpperLimit': '3.99', 'estimateComment': 'treatment difference=experimental-control, where the outcome for each individual is (one month)-baseline.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was a point null of exactly 0 difference in expected change from baseline in number of cigarettes smoked per day between arms.'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline and 1 month', 'description': 'Change in number of cigarettes smoked per day from baseline, calculated as (1 month)-baseline.', 'unitOfMeasure': 'Cigarettes/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals who installed the app, returned the 1-month survey, and either responded to this item or reported not smoking in the past 7 days. If they reported not smoking for the past 7 days, number of cigarettes were day were coded as 0.'}, {'type': 'SECONDARY', 'title': 'Change in Cigarettes/Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}], 'classes': [{'title': 'Baseline 30-day average cigarettes/day', 'categories': [{'measurements': [{'value': '17.6', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '17.9', 'spread': '8.0', 'groupId': 'OG001'}]}]}, {'title': 'Change in daily average cigarettes/day between baseline and three-month (using 7-day average)', 'categories': [{'measurements': [{'value': '-6.7', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '-5.2', 'spread': '7.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.47', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '-2.51', 'ciUpperLimit': '5.5', 'estimateComment': 'treatment effect=experimental-control, where the outcome for each individual is (three month)-baseline.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was a point null of exactly 0 difference in expected change in daily cigarette usage between arms.'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline and 3 months', 'description': 'Change in number of cigarettes smoked per day from baseline, calculated as (3 months)-baseline.', 'unitOfMeasure': 'Cigarettes/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals who installed the app, returned the 3-month survey, and either responded to this item or reported not smoking in the past 7 days. If they reported not smoking for the past 7 days, number of cigarettes were day were coded as 0.'}, {'type': 'SECONDARY', 'title': 'Refrain From Smoking (Even a Puff) in the Last 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.11', 'estimateComment': 'risk difference=experimental-control', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was risk difference of exactly 0.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed at 1-month follow-up', 'description': '7-day point prevalent abstinence: a self-report of not smoking, even a puff, in the past 7 days. Missing outcomes were imputed as smoking.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals who installed the app (n = 57).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'FG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Completed 1-month Self-report Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Completed 3-month Self-report Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Completed App Utilization Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study enrollment began 12/16/2020 and study activities completed 9/27/21. Participants were recruited through two sources: (1) social media ads inviting individuals to email contact study staff to learn more and be screened for eligibility and (2) outreach to people our research waitlist.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Control mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'BG001', 'title': 'Experimental', 'description': 'Experimental mHealth program: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.\n\nNicotine patch: Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.1', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '47.9', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '47.5', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cigarettes per day', 'classes': [{'categories': [{'measurements': [{'value': '17.8', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '18.5', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '18.2', 'spread': '7.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cigarettes/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'At least one quit attempt lasting a day or longer in the past 12 months', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': '7-day point prevalence abstinence', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Positive if the participant abstained from smoking (even a puff) in the past 7 days.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-22', 'size': 462721, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-09-26T11:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-03', 'studyFirstSubmitDate': '2020-06-15', 'resultsFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2020-09-17', 'lastUpdatePostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-03', 'studyFirstPostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Program Engagement', 'timeFrame': 'Assessed at 3-month follow-up', 'description': 'Number of unique app user-sessions'}, {'measure': 'Quit Attempt Lasting at Least 24 Hours', 'timeFrame': 'Assessed at 3-month follow-up', 'description': 'At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt.'}, {'measure': 'Not Smoking (Even a Puff) in the Last 7 Days', 'timeFrame': 'Assessed at 3-month follow-up', 'description': '7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking.'}], 'secondaryOutcomes': [{'measure': 'Satisfaction With Assigned App', 'timeFrame': 'Assessed at 1 month', 'description': 'Satisfaction with the overall "content and advice" of the assigned app, rated on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".'}, {'measure': 'Satisfaction With Assigned App', 'timeFrame': 'Assessed at 3 months', 'description': 'Satisfaction with the overall "content and advice" of the assigned app on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".'}, {'measure': 'Helpfulness of Assigned App', 'timeFrame': 'Assessed at 1 month.', 'description': 'Global helpfulness rating calculated as the average helpfulness rating of 8 app features, each rated on a Likert scale from 1="not at all helpful" to 5="extremely helpful".'}, {'measure': 'Helpfulness of Assigned App', 'timeFrame': 'Assessed at 3 months', 'description': 'Average helpfulness rating of 8 separate app features, with each feature rated on a Likert scale from 1="not at all helpful" to 5="extremely helpful".'}, {'measure': 'Program Engagement - Earned Badges', 'timeFrame': 'Assessed at 1-month follow-up', 'description': 'Number of accumulated badge rewards earned from using the assigned app.'}, {'measure': 'Program Engagement - Earned Badges', 'timeFrame': 'Assessed at 3-month follow-up', 'description': 'Number of accumulated badge rewards earned from using the assigned app.'}, {'measure': 'Self-efficacy to Quit Smoking', 'timeFrame': 'Assessed at 1 month', 'description': 'Self-reported confidence in quitting smoking on Likert scale from 1="not at all" to 10="extremely".'}, {'measure': 'Self-efficacy to Quit Smoking', 'timeFrame': 'Assessed at 3 months', 'description': 'Self-reported confidence in quitting smoking on a Likert scale from 1="not at all" to 10="extremely".'}, {'measure': 'Self-efficacy to Stay Quit', 'timeFrame': 'Assessed at 1 month', 'description': 'Self-reported confidence in ability to stay quit on a Likert scale from 1="not at all" to 10="extremely".'}, {'measure': 'Self-efficacy to Stay Quit', 'timeFrame': 'Assessed at 3 months', 'description': 'Self-reported confidence in ability to stay quit (if no smoking in the past 7 days) on a Likert scale from 1="not at all" to 10="extremely".'}, {'measure': 'Earned and Requested Free Nicotine Replacement Therapy', 'timeFrame': 'Assessed at 1-month follow-up', 'description': 'Earned and requested free nicotine replacement therapy (NRT); free NRT could be earned by earning 6 app utilization badges.'}, {'measure': 'Earned and Requested Free Nicotine Replacement Therapy', 'timeFrame': 'Assessed at 3-month follow-up', 'description': 'Earned and requested free nicotine replacement therapy (NRT); free NRT could be earned by earning 6 app utilization badges.'}, {'measure': 'Quit Attempt Lasting at Least 24 Hours', 'timeFrame': 'Assessed at 1 month follow-up', 'description': 'At least one intentional smoking quit attempt lasting at least 24 hours; non-respondents were assumed to not have a successful quit attempt.'}, {'measure': 'Change in Cigarettes/Day', 'timeFrame': 'Assessed at baseline and 1 month', 'description': 'Change in number of cigarettes smoked per day from baseline, calculated as (1 month)-baseline.'}, {'measure': 'Change in Cigarettes/Day', 'timeFrame': 'Assessed at baseline and 3 months', 'description': 'Change in number of cigarettes smoked per day from baseline, calculated as (3 months)-baseline.'}, {'measure': 'Refrain From Smoking (Even a Puff) in the Last 7 Days', 'timeFrame': 'Assessed at 1-month follow-up', 'description': '7-day point prevalent abstinence: a self-report of not smoking, even a puff, in the past 7 days. Missing outcomes were imputed as smoking.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mHealth', 'smoking', 'smoking cessation', 'motivation'], 'conditions': ['Tobacco Use Disorder', 'Smoking Cessation', 'Motivation', 'Behavior, Smoking']}, 'referencesModule': {'references': [{'pmid': '37379059', 'type': 'DERIVED', 'citation': 'McClure JB, Heffner JL, Krakauer C, Mun S, Klasnja P, Catz SL. Feasibility, Acceptability, and Potential Impact of a Novel mHealth App for Smokers Ambivalent About Quitting: Randomized Pilot Study. JMIR Mhealth Uhealth. 2023 Jun 28;11:e46155. doi: 10.2196/46155.'}]}, 'descriptionModule': {'briefSummary': 'The current pilot study will assess the feasibility and acceptability of a novel mHealth app designed for people who are ambivalent about quitting smoking. Results will be used to refine the intervention and plan for a future randomized effectiveness trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older;\n* Can speak/read English;\n* Current smoker;\n* Own and regularly use an eligible smartphone;\n* No vision impairments;\n* Willing to install and use the study program;\n* Willing to use birth control if elect to use nicotine replacement during the study (females);\n* Meet definition for ambivalence\n* Not actively using treatment\n\nExclusion Criteria:\n\n* Smoke less than 10 cigarettes per day\n* Self-report a lifetime history of dementia, manic depression, bipolar disorder, or schizophrenia;\n* Have medical contraindications for nicotine replacement therapy;\n* Another household member is enrolled in the study\n* Unable to verify contact information\n* Fail to install app'}, 'identificationModule': {'nctId': 'NCT04560868', 'briefTitle': 'Development of a mHealth Intervention for Ambivalent Smokers', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Development of a mHealth Intervention for Ambivalent Smokers', 'orgStudyIdInfo': {'id': '1401452'}, 'secondaryIdInfos': [{'id': 'R21CA234003', 'link': 'https://reporter.nih.gov/quickSearch/R21CA234003', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Device: Control mHealth program', 'Drug: Nicotine patch']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'interventionNames': ['Device: Experimental mHealth program', 'Drug: Nicotine patch']}], 'interventions': [{'name': 'Control mHealth program', 'type': 'DEVICE', 'description': 'The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.', 'armGroupLabels': ['Control']}, {'name': 'Experimental mHealth program', 'type': 'DEVICE', 'description': 'The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.', 'armGroupLabels': ['Experimental']}, {'name': 'Nicotine patch', 'type': 'DRUG', 'description': 'Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.', 'armGroupLabels': ['Control', 'Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Kaiser Permanente Washington Health Research Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Jennifer McClure, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}