University of Vermont Medical Center
Burlington, Vermont, 05405, United States
Location status: Recruiting
NCT Number: NCT05738408
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Burlington, Vermont, 05405, United States
Location status: Recruiting
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
Acute 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.
Financial 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients will be recruited if they:
Exclusion criteria
Patients will be excluded if they have:
: 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
Time frame: 3 months
Assess the efficacy of combined FI+NRT vs. UC on biochemically verified smoking abstinence
Time frame: 3 months
Determine the effect of smoking status on changes in cardiovascular fitness (VO2peak).
Time frame: 3 months
Cigarettes per day (CPD) using timeline follow back methods
Time frame: 3 months
Fagerstrom Test for Nicotine Dependence [FTND]
Time frame: 3 months
Heaviness of Smoking Index (HSI)
Time frame: 3 months
and the Minnesota Nicotine Withdrawal Scale
Time frame: 3 months
CO monitoring
Time frame: 3 months
The General Health Status MOS SF-36 questionnaire will be administered with special attention to the physical function component score.
Time frame: 3 months
EuroQol
Time frame: 3 months
disease specific MacNew Cardiac Health Status Questionnaire will be administered
Time frame: 3 months
mood will be measured using the Patient Health Questionnaire (PHQ-9)
Time frame: 3 months
the General Anxiety Disorder questionnaire (GAD-7)Questionnaire will be administered to assess anxiety
Time frame: 3 months
Time frame: 12 months
Combined measure of number of Emergency Department visits and overnight hospitalizations
Contact information is provided by the study sponsor or research team.
Diann Gaalema, PhD
CONTACT
Sherrie Khadanga, MD
CONTACT
University of Vermont Medical Center
Other
Remote Smoking Cessation in Hospitalized Cardiac Patients: Bridging the Post-discharge
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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