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Post Acute Cardiac Event Smoking (PACES) Study

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ClinicalTrials.gov Identifier: NCT03413423
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : August 9, 2018
Sponsor:
Collaborators:
Minneapolis Heart Institute Foundation
The Miriam Hospital
National Heart, Lung, and Blood Institute (NHLBI)
University of Minnesota, MN
Information provided by (Responsible Party):
Andrew Busch, Hennepin Healthcare Research Institute.

Tracking Information
First Submitted Date  ICMJE January 19, 2018
First Posted Date  ICMJE January 29, 2018
Last Update Posted Date August 9, 2018
Actual Study Start Date  ICMJE January 29, 2018
Estimated Primary Completion Date January 29, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
  • 7-day point prevalence abstinence from smoking [ Time Frame: 12 Months ]
    Self-report of no smoking, not even a puff, for 7 days; then Bio-chemically confirmed with saliva cotinine or by carbon monoxide in a breath sample
  • Depression Symptoms [ Time Frame: 12 Months ]
    The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03413423 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
  • Continuous Abstinence From Smoking Since Hospital Discharge [ Time Frame: 12 Months ]
    No smoking, not even a puff, since hospital discharge
  • Time to Smoking Relapse [ Time Frame: 12 Months ]
    Time in days to first relapse (i.e., smoking on 7 consecutive days or smoking in 2 consecutive 7 day periods), which were determined through timeline follow back interviewing.
  • Time to Smoking Lapse [ Time Frame: 12 Months ]
    Time in days to first lapse (i.e., first puff of a cigarette) after discharge, which were determined through timeline follow back interviewing.
  • Depressed mood [ Time Frame: The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms. ]
    10 Item Center for Epidemiologic Studies Depression Scale (CESD)
  • Positive Affect [ Time Frame: 12 Months ]
    As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect.
  • Negative Affect [ Time Frame: 12 Months ]
    As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect.
  • Systolic and Diastolic Blood Pressure [ Time Frame: 12 Months ]
    Resting Systolic and Diastolic Blood Pressure
  • Blood Bio-markers [ Time Frame: 12 Months ]
    HDL, LDL, High Sensitivity C-reactive protein, and Fibrinogen
  • Major adverse cardiac events (MACE) and all cause mortality [ Time Frame: 5 years ]
    Time in days to MACE or all cause mortality. MACE = non-fatal myocardial infarction (using standard American Heart Association definitions), hospitalization for unstable angina, or urgent coronary revascularization.
  • Health Related Quality of Life [ Time Frame: 12 Months ]
    12-Item Short Form Health Survey (SF-12)
  • Treatment Acceptability [ Time Frame: 12 weeks ]
    Client Satisfaction Questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post Acute Cardiac Event Smoking (PACES) Study
Official Title  ICMJE Secondary Prevention Following Acute Coronary Syndrome Using Integrated Smoking Cessation and Mood Management
Brief Summary

Summary of the Project :

Quitting smoking following acute coronary syndrome (ACS) can reduce mortality up to 50%. However, depression and smoking are highly co-morbid and depressed mood may interfere with cessation and independently predicts mortality. Thus, a single, integrated treatment for both smoking and depression could be highly effective in reducing post-acute coronary syndrome mortality. Behavioral Activation (BA) is a well established treatment for depression and has recently shown promise as a treatment for smoking cessation. The investigators systematically developed an intervention integrating gold standard smoking cessation counseling with existing BA based mood management techniques for post-ACS smokers; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS).

Objective: For this R01 the investigators will evaluate the efficacy of using a single, integrated treatment that targets both depressed mood and smoking (BAT-CS).

Detailed Description This project will implement a fully powered efficacy trial enrolling 324 smokers with ACS and randomize them to 12 weeks of either Behavioral Activation Treatment for Cardiac Smokers (BAT-CS) or control condition (including contact match). BAT-CS interventions will focus on smoking cessation and mood management, while the control condition will focus on smoking cessation and general health education. Both groups will be offered the nicotine patch if medically safe. Follow-up assessments will be conducted at end-of-treatment (12 weeks post-discharge for index event), and 6, 9, and 12 months after hospital discharge. The occurrence of major adverse cardiac events and all-cause mortality will be tracked for up to 60 months post discharge.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Coronary Syndrome
  • Tobacco Use
Intervention  ICMJE
  • Behavioral: BAT-CS
    All participants will receive one hour standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to BAT-CS condition will receive 5 more counseling sessions over the 12 weeks after discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur by phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and mood management using behavioral activation techniques. Participants will be offered the nicotine patch if medically cleared.
    Other Name: Smoking Cessation and Mood Management
  • Behavioral: Smoking Cessation and Health & Wellness
    All participants will receive one hour of standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to the Smoking Cessation plus Health and Wellness condition will receive 5 more counseling sessions over the 12 weeks after hospital discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur over the phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and didactic health and wellness education. Participants will be offered the nicotine patch if medically cleared.
Study Arms  ICMJE
  • Experimental: BAT-CS
    Participants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared.
    Intervention: Behavioral: BAT-CS
  • Active Comparator: Smoking Cessation and Health & Wellness
    Participants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared.
    Intervention: Behavioral: Smoking Cessation and Health & Wellness
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 26, 2018)
324
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 29, 2026
Estimated Primary Completion Date January 29, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • hospital inpatients with an ACS diagnosis documented in medical record
  • smoked equal or greater than 1 cigarette per day before being hospitalized
  • age of 18-75 years
  • English fluency
  • lives within a 1.5 hour drive of study hospital and has no plans to move away from the area for 1 year
  • willing to consider quitting smoking at discharge
  • has a telephone
  • willing to consent to all study procedures.

Exclusion Criteria:

  • limited mental competency
  • presence of severe mental illness that would interfere with participation or suicidality
  • expected discharge to hospice or greater than 50% chance of 6 month mortality per risk calculator
  • currently attending counseling for depression or smoking cessation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andrew Busch, PhD 612-873-6681 andrew.busch@hcmed.org
Contact: Michelle L Chrastek, MPH 612-873-5364 michelle.chrastek@hcmed.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03413423
Other Study ID Numbers  ICMJE 17-4375
1R01HL136327 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Completely de-identified data (i.e.,data that has been cleaned of all 18 types of HIPAA identifiers) will be available to other qualified researchers. Within 18 months of study completion, we will make datasets available to interested investigators who submit a written request to the PI. The only contingency on the use of the data will be that ethical guidelines be followed (e.g., only individuals who have completed a research ethics training course will have access to the data, the data will be stored securely). The NIH will be notified of transmissions of the data to interested investigators.
Responsible Party Andrew Busch, Hennepin Healthcare Research Institute.
Study Sponsor  ICMJE Hennepin Healthcare Research Institute.
Collaborators  ICMJE
  • Minneapolis Heart Institute Foundation
  • The Miriam Hospital
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Minnesota, MN
Investigators  ICMJE
Principal Investigator: Andrew Busch, PhD Senior Investigator
PRS Account Hennepin Healthcare Research Institute.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP