Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 3:23 PM
Study NCT ID:
NCT05738408
Status:
RECRUITING
Last Update Posted:
2025-01-20
First Post:
2022-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remote Smoking Cessation in Hospitalized Cardiac Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000095488', 'term': 'Nicotine Replacement Therapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2022-06-06', 'studyFirstSubmitQcDate': '2023-02-10', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Smoking Characteristics', 'timeFrame': '3 months', 'description': 'Cigarettes per day (CPD) using timeline follow back methods'}, {'measure': 'Smoking Characteristics', 'timeFrame': '3 months', 'description': 'Fagerstrom Test for Nicotine Dependence \\[FTND\\]'}, {'measure': 'Smoking Characteristics', 'timeFrame': '3 months', 'description': 'Heaviness of Smoking Index (HSI)'}, {'measure': 'Smoking Characteristics', 'timeFrame': '3 months', 'description': 'and the Minnesota Nicotine Withdrawal Scale'}, {'measure': 'Smoking Status', 'timeFrame': '3 months', 'description': 'CO monitoring'}, {'measure': 'Physical Function assessed by MOS SF-36', 'timeFrame': '3 months', 'description': 'The General Health Status MOS SF-36 questionnaire will be administered with special attention to the physical function component score.'}, {'measure': 'Quality of Life assessed by EuroQol questionnaire', 'timeFrame': '3 months', 'description': 'EuroQol'}, {'measure': 'Quality of Life assessed by MacNew Cardiac Health questionnaire', 'timeFrame': '3 months', 'description': 'disease specific MacNew Cardiac Health Status Questionnaire will be administered'}, {'measure': 'Depression assessed by PHQ-9 questionnaire', 'timeFrame': '3 months', 'description': 'mood will be measured using the Patient Health Questionnaire (PHQ-9)'}, {'measure': 'Anxiety assessed by GAD-7 Questionnaire', 'timeFrame': '3 months', 'description': 'the General Anxiety Disorder questionnaire (GAD-7)Questionnaire will be administered to assess anxiety'}, {'measure': 'Risk Aversion Assessment', 'timeFrame': '3 months'}, {'measure': 'Health Care Contacts', 'timeFrame': '12 months', 'description': 'Combined measure of number of Emergency Department visits and overnight hospitalizations'}], 'primaryOutcomes': [{'measure': 'Biochemical verification of smoking status', 'timeFrame': '3 months', 'description': 'Assess the efficacy of combined FI+NRT vs. UC on biochemically verified smoking abstinence'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular Fitness', 'timeFrame': '3 months', 'description': 'Determine the effect of smoking status on changes in cardiovascular fitness (VO2peak).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['smoking cessation', 'secondary prevention'], 'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'The investigators are proposing to examine new strategies for helping patients hospitalized for an acute coronary event adhere to recommendations to quit smoking. The investigators are interested to see whether offering financial incentives for smoking cessation, combined with medications to ameliorate withdrawal, can significantly reduce smoking in a population for which continued smoking has disproportionately negative health effects. The proposed trial can provide significant knowledge for promoting adherence to smoking cessation guidelines in patients with cardiac disease', 'detailedDescription': 'Cigarette smoking is the leading cause of preventable death in the U.S. The effect of smoking in those with coronary artery disease (CAD) is particularly powerful given that at hospital admission, 27-36% of these patients are active smokers which is much higher than in the general population (\\<18%).1-3While smoking rates have declined in the U.S., this has not been observed in cardiac populations. Continued smoking after hospitalization also predicts additional negative outcomes such as lack of engagement in comprehensive secondary prevention for example cardiac rehabilitation (CR).4 Smoking may also directly impede improvements in fitness which is a critical predictor of recovery in this population and thus crucial to examine.5-7 Surprisingly, having a serious cardiac event, such as a myocardial infarction (MI) may not be enough to promote sustained cessation.8 Thus, promoting adherence to smoking cessation guidelines in this population is of utmost importance.9\n\nAcute cardiac hospitalization does provide an ideal opportunity to intervene on smoking.10 Patients are required to abstain from smoking while hospitalized and are often motivated to quit. Unfortunately, less than a quarter of patients receive Nicotine Replacement Therapy (NRT) in-hospital and even fewer receive support after discharge. 11,12 For most patients, follow-up care may not occur for 4-6 weeks and most patients relapse to smoking within the first few weeks.11,13 Ideally, intensive intervention would be started in-hospital and continue after discharge, bridging this post-hospital gap in care.\n\nFinancial incentives (FI) for objectively verified smoking abstinence is highly effective in promoting smoking cessation in medically vulnerable populations, but, to the Investigators knowledge, has not been tested in patients with CVD.14.15 NRT is safe in cardiac patients, but is rarely prescribed or offered in a manner that maximizes efficacy (i.e., combination short and long-acting NRT).16 Building on our strong published and preliminary data, the investigators hypothesize that a combined behavioral and pharmacologic smoking cessation intervention started in hospital and continued remotely can bridge the post-hospital care gap and support patients through a critical period in cardiac recovery where risk of smoking relapse is high.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients will be recruited if they:\n\n1. Hospitalization for an acute coronary event which includes myocardial infarction or coronary revascularization (percutaneous intervention or coronary artery bypass)\n2. live within 30 miles of UVMMC and are \\>18 years of age\n3. Current cigarette smoker (defined as reporting any use of cigarettes in the week before admission and \\>5 cigarette/day on average over the past 3 months)\n\nExclusion Criteria:\n\nPatients will be excluded if they have:\n\n1. severe dementia/Alzheimer's disease\n2. an active malignancy, excluding non-melanoma skin cancer or low-grade prostate cancer under active surveillance\n3. exercise limiting vascular or neuromuscular disease\n4. Non-English Speaking\n5. No reliable smart-phone\n6. Current, regular use of smokeless tobacco or other form of non-combusted tobacco"}, 'identificationModule': {'nctId': 'NCT05738408', 'briefTitle': 'Remote Smoking Cessation in Hospitalized Cardiac Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Vermont Medical Center'}, 'officialTitle': 'Remote Smoking Cessation in Hospitalized Cardiac Patients: Bridging the Post-discharge', 'orgStudyIdInfo': {'id': 'STUDY00002035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control: Usual Care', 'description': 'will receive standard treatment which entails referral to Vermont Quit Network. This network offers a wide range of free cessation services, including NRT and web-based modules on preparing to quit and developing a plan'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention: Financial incentives and nicotine replacement therapy intervention', 'description': 'an intervention where patients are assigned to financial incentives and NRT of their choice; use of CO monitor to assess abstinence', 'interventionNames': ['Behavioral: Financial Incentives (FI) and Nicotine Replacement Therapy (NRT)']}], 'interventions': [{'name': 'Financial Incentives (FI) and Nicotine Replacement Therapy (NRT)', 'type': 'BEHAVIORAL', 'description': ': In the intervention condition, patients will receive both NRT plus a 12-week program of monetary incentives for verified smoking abstinence that will be implemented by our clinic staff', 'armGroupLabels': ['Intervention: Financial incentives and nicotine replacement therapy intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05405', 'city': 'Burlington', 'state': 'Vermont', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sherrie Khadanga', 'role': 'CONTACT', 'email': 'sherrie.khadanga@uvmhealth.org', 'phone': '802-847-2700'}], 'facility': 'University of Vermont Medical Center', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'centralContacts': [{'name': 'Sherrie Khadanga, MD', 'role': 'CONTACT', 'email': 'sherrie.khadanga@uvmhealth.org', 'phone': '802-847-2700'}, {'name': 'Diann Gaalema, PhD', 'role': 'CONTACT', 'email': 'diann.gaalema@med.uvm.edu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vermont Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Sherrie Khadanga', 'investigatorAffiliation': 'University of Vermont Medical Center'}}}}