Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-03-03 @ 3:00 PM
Study NCT ID:
NCT01791803
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2013-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Smoking Cessation After Hospitalization for a Cardiopulmonary Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006990', 'term': 'Hypnosis'}, {'id': 'D009538', 'term': 'Nicotine'}, {'id': 'D000095488', 'term': 'Nicotine Replacement Therapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fhasan@partners.org', 'phone': '978-741-1200', 'title': 'Dr. Faysal M. Hasan', 'phoneExt': '4901', 'organization': 'North Shore Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Comparing two vastly different modalities such as hypnosis and NRT represented a randomizing challenge, as participants and researchers could not be blinded to interventions.'}}, 'adverseEventsModule': {'timeFrame': '12 and 26 weeks after hospital discharge', 'eventGroups': [{'id': 'EG000', 'title': 'Hypnotherapy', 'description': 'patients receiving a free intensive session of hypnotherapy within 2 weeks of hospitalization', 'otherNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nicotine Replacement Therapy', 'description': 'Patients receiving a free months supply of nicotine', 'otherNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Hypnotherapy and Nicotine Replacement', 'description': 'Patients receiving hypnotherapy and nicotine supply', 'otherNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Self-Quit Group', 'description': 'patient who decided to quit on their own', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Abstinence From Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypnotherapy', 'description': 'Patients admitted with a cardiopulmonary illness received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.\n\nhypnotherapy: One 90 minute session within 2 weeks of hospital discharge'}, {'id': 'OG001', 'title': 'Nicotine Replacement Therapy', 'description': 'Patients received a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.\n\nNicotine: free one month supply after hospital discharge'}, {'id': 'OG002', 'title': 'Hypnotherapy and Nicotine Replacement', 'description': 'The group received similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nicotine replacement supplies for a month after discharge.\n\nhypnotherapy: One 90 minute session within 2 weeks of hospital discharge\n\nNicotine: free one month supply after hospital discharge'}, {'id': 'OG003', 'title': 'Self-Quit Group', 'description': 'patients were given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '1.1', 'ciUpperLimit': '11.4', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '1.04', 'ciUpperLimit': '9.7', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'at 26 weeks after hospitalization', 'description': 'Assessed by 7-day prevalence of verified tobacco abstinence at 26 weeks after hospitalization for a cardiopulmoanry illness. Verification was confirmed biochemically by urine Cotinine testing or by telephone and discussion with a household proxy. Patients lost to follow up were considered to be persistent smokers.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Smoking Cessation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypnotherapy', 'description': 'Patients admitted with a cardiopulmonary illness received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They will also recieve self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.\n\nhypnotherapy: One 90 minute session within 2 weeks of hospital discharge'}, {'id': 'OG001', 'title': 'Nicotine Replacement Therapy', 'description': 'Patients received a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.\n\nNicotine: free one month supply after hospital discharge'}, {'id': 'OG002', 'title': 'Hypnotherapy and Nicotine Replacement', 'description': 'The group received similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nicotine replacement supplies for a month after discharge.\n\nhypnotherapy: One 90 minute session within 2 weeks of hospital discharge\n\nNicotine: free one month supply after hospital discharge'}, {'id': 'OG003', 'title': 'Self-Quit Group', 'description': 'patients were given brief counseling during hospitalization and were not be contacted until 26 weeks after hospitalization.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '0.8', 'ciUpperLimit': '6.2', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for gender, marital status, diagnosis at enrollment.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '1.2', 'ciUpperLimit': '10', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 12 weeks after hospitalization', 'description': 'Abstinence from smoking at 12 weeks after hospitalization was measured by self reported 7-day prevalence and verified urinary Cotinine test. This included participants in groups receiving hypnotherapy, NRT or both. Self quit group was not approached until 26 weeks after discharge. Patients lost to follow up were considered smokers.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Smoking Abstinence Rate at 12 and 26 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Smoking Abstinence Rates at 12 and 26 Weeks', 'description': 'Smoking status at follow-up time at 12 and 26 weeks by diagnosis status (cardiac vs. pulmonary)'}], 'classes': [{'title': '% Quit rate for cardiac diagnosis at 12 weeks', 'categories': [{'measurements': [{'value': '52.1', 'groupId': 'OG000'}]}]}, {'title': '% Quit rate for pulmonary diagnosis at 12 weeks', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': '% Quit rate for cardiac diagnosis at 26 weeks', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': '% quit rate for pulmonary diagnosis at 26 weeks', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Comparison of smoking status at 12 weeks after hospitalization for a cardiac or pulmonary diagnosis', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.07', 'groupIds': ['OG000'], 'groupDescription': 'Comparison of smoking stars at 26 weeks after hospitalization for a cardiac or a pulmonary illness', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks and 26 weeks after hospital discharge', 'description': 'Abstinence rates were calculated for patients hospitalized with a cardiac or a pulmonary diagnosis.', 'unitOfMeasure': 'percentage of smoking abstinence rate', 'reportingStatus': 'POSTED', 'populationDescription': 'Abstinence comparing the 2 admitting diagnoses was similar within each arm, thus analysis for admitting diagnosis was done combining the 4 arms.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hypnotherapy', 'description': 'Patients admitted with a cardiopulmonary illness will receive a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They will also recieve self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.\n\nhypnotherapy: One 90 minute session within 2 weeks of hospital discharge'}, {'id': 'FG001', 'title': 'Nicotine Replacement Therapy', 'description': 'Patients will recieve a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients will receive self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.\n\nNicotine: free one month supply after hospital discharge'}, {'id': 'FG002', 'title': 'Hypnotherapy and Nicotine Replacement', 'description': 'The group will recieve similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nictotine replacement supplies for a month after discharge.\n\nhypnotherapy: One 90 minute session within 2 weeks of hospital discharge\n\nNicotine: free one month supply after hospital discharge'}, {'id': 'FG003', 'title': 'Self-Quit Group', 'description': 'patients will be given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '164', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Hypnotherapy', 'description': 'Patients received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use . They also received counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.'}, {'id': 'BG001', 'title': 'Nicotine Replacement Therapy', 'description': 'Patients received a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays, self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.'}, {'id': 'BG002', 'title': 'Hypnotherapy and Nicotine Replacement', 'description': 'patients recieved both a similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nictotine replacement supplies for a month after discharge.'}, {'id': 'BG003', 'title': 'Self-Quit Group', 'description': 'Patients were given brief counseling during hospitalization and were not contacted until 26 weeks after hospitalization. They received no telephone contact and or counseling after discharge.'}, {'id': 'BG004', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '164', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.0', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '55.3', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '54.4', 'spread': '8.9', 'groupId': 'BG002'}, {'value': '56.0', 'spread': '10.7', 'groupId': 'BG003'}, {'value': '55.17', 'spread': '1.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '91', 'groupId': 'BG004'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '137', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'White Race ( n, %)', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '164', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Years of education', 'classes': [{'categories': [{'measurements': [{'value': '13', 'spread': '2', 'groupId': 'BG000'}, {'value': '12.6', 'spread': '2', 'groupId': 'BG001'}, {'value': '13.2', 'spread': '1.8', 'groupId': 'BG002'}, {'value': '13.2', 'spread': '1.9', 'groupId': 'BG003'}, {'value': '13', 'spread': '1.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of cigarettes smoked', 'classes': [{'categories': [{'measurements': [{'value': '19.8', 'spread': '12.6', 'groupId': 'BG000'}, {'value': '21.2', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '20.5', 'spread': '9.3', 'groupId': 'BG002'}, {'value': '15', 'spread': '10', 'groupId': 'BG003'}, {'value': '19.12', 'spread': '11.12', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Cigarettes smoked /day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total years of smoking', 'classes': [{'categories': [{'measurements': [{'value': '36.5', 'spread': '12.7', 'groupId': 'BG000'}, {'value': '34.2', 'spread': '14.4', 'groupId': 'BG001'}, {'value': '34.3', 'spread': '11.7', 'groupId': 'BG002'}, {'value': '33.2', 'spread': '10.8', 'groupId': 'BG003'}, {'value': '34.55', 'spread': '12.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Living with a smoker', 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Admitted with Cardiac Diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lost to Follow up (Considered non-quitters)', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'patients included in analysis were less than numbers recruited in groups because some patients were eliminated due to severity of illness including mortality and one developed psychosis, thus became eligible. All patients that were lost to follow up were considered to be smokers for analysis.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-17', 'studyFirstSubmitDate': '2013-02-12', 'resultsFirstSubmitDate': '2014-04-16', 'studyFirstSubmitQcDate': '2013-02-13', 'lastUpdatePostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-17', 'studyFirstPostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abstinence From Smoking', 'timeFrame': 'at 26 weeks after hospitalization', 'description': 'Assessed by 7-day prevalence of verified tobacco abstinence at 26 weeks after hospitalization for a cardiopulmoanry illness. Verification was confirmed biochemically by urine Cotinine testing or by telephone and discussion with a household proxy. Patients lost to follow up were considered to be persistent smokers.'}], 'secondaryOutcomes': [{'measure': 'Smoking Cessation', 'timeFrame': 'at 12 weeks after hospitalization', 'description': 'Abstinence from smoking at 12 weeks after hospitalization was measured by self reported 7-day prevalence and verified urinary Cotinine test. This included participants in groups receiving hypnotherapy, NRT or both. Self quit group was not approached until 26 weeks after discharge. Patients lost to follow up were considered smokers.'}, {'measure': 'Smoking Abstinence Rate at 12 and 26 Weeks', 'timeFrame': '12 weeks and 26 weeks after hospital discharge', 'description': 'Abstinence rates were calculated for patients hospitalized with a cardiac or a pulmonary diagnosis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking cessation', 'Tobacco abstinence', 'hypnotherapy', 'Nicotine replacement therapy'], 'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'Smoking-related cardiopulmonary diseases account for a large number of hospital admissions. We investigated the efficacy of hypnotherapy as an aid to a counseling-based smoking cessation program in improving quit rates of hospitalized smoking patients at 12 and 26 weeks after hospital discharge. We compared outcomes with hospitalized patients who received more conventional therapy, namely nicotine replacement therapy, or patients who decided to quit on their own. We also compared smoking cessation rates at 12 and 26 weeks after hospitalization among patients admitted with a cardiac or a pulmonary diagnosis.', 'detailedDescription': 'Hospitalized patients with a cardiopulmonary diagnosis who were contemplating quitting were recruited into 4 groups: Hypnotherapy, Nicotine replacement therapy (NRT), both hypnotherapy and NRT, and self-quit group. All patients received self-help brochures and in-hospital counseling. Intervention groups received more extensive counseling, free NRT supply for a month and/or a 90 minute hypnotherapy session within 2 weeks of discharge. They also had follow up telephone counseling at 1,2,4,8 and 12 weeks after discharge. 7 day prevalence of tobacco abstinence rates at 26 weeks after hospitalization were verified by self report and urinary Cotinine levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized patients with a Cardiopulmonary admission.\n\nExclusion Criteria:\n\n* Terminal illness, history of Serious Psychiatric illness or substance abuse, Pregnancy, Cognitive or language barriers.'}, 'identificationModule': {'nctId': 'NCT01791803', 'acronym': 'STOPP', 'briefTitle': 'Smoking Cessation After Hospitalization for a Cardiopulmonary Illness', 'organization': {'class': 'OTHER', 'fullName': 'North Shore Medical Center'}, 'officialTitle': 'Smoking Cessation Treatment of CardioPulmonary Hospitalized Patients', 'orgStudyIdInfo': {'id': 'STOPP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypnotherapy', 'description': 'Patients admitted with a cardiopulmonary illness received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.', 'interventionNames': ['Behavioral: hypnotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Nicotine Replacement Therapy', 'description': 'Patients recieved a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.', 'interventionNames': ['Drug: Nicotine']}, {'type': 'EXPERIMENTAL', 'label': 'Hypnotherapy and Nicotine replacement', 'description': 'The group received similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nicotine replacement supplies for a month after discharge.', 'interventionNames': ['Behavioral: hypnotherapy', 'Drug: Nicotine']}, {'type': 'NO_INTERVENTION', 'label': 'Self-Quit group', 'description': 'Patients were given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.'}], 'interventions': [{'name': 'hypnotherapy', 'type': 'BEHAVIORAL', 'otherNames': ['hypnosis'], 'description': 'One 90 minute session within 2 weeks of hospital discharge', 'armGroupLabels': ['Hypnotherapy', 'Hypnotherapy and Nicotine replacement']}, {'name': 'Nicotine', 'type': 'DRUG', 'otherNames': ['Nicotine replacement therapy'], 'description': 'free one month supply after hospital discharge', 'armGroupLabels': ['Hypnotherapy and Nicotine replacement', 'Nicotine Replacement Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01970', 'city': 'Salem', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'North Shore Medical Center', 'geoPoint': {'lat': 42.51977, 'lon': -70.89552}}], 'overallOfficials': [{'name': 'Faysal Hasan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Shore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'published in: Complementary Therapies in Medicine 2014: 22: 1-8.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Shore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Tobacco Prevention Service', 'investigatorFullName': 'Faysal M. Hasan, MD', 'investigatorAffiliation': 'North Shore Medical Center'}}}}