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Post Acute Coronary Event Smoking Study (PACES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01964898
Recruitment Status : Completed
First Posted : October 17, 2013
Results First Posted : January 12, 2017
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Andrew Busch, The Miriam Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Smoking Cessation
Acute Coronary Syndrome
Interventions Behavioral: Behavioral Activation (BA)
Behavioral: Standard Smoking Cessation Counseling
Drug: Nicotine patch
Other: Printed Self-help materials for Smoking Cessation
Enrollment 65
Recruitment Details  
Pre-assignment Details 65 patients were recruited. 1 was found to be ineligible pre-randomization.
Arm/Group Title BA for Cardiac Patients Who Smoke Standard Care
Hide Arm/Group Description

Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Printed Self-help materials for Smoking Cessation

Period Title: Overall Study
Started 31 33
12 Week Assessment 25 30
Completed [1] 24 26
Not Completed 7 7
Reason Not Completed
ineligible post-randomization             1             1
did not receive the allocated interventi             2             1
Lost to Follow-up             3             5
Withdrawal by Subject             1             0
[1]
Completed assessment 6 months post-discharge
Arm/Group Title BA for Cardiac Patients Who Smoke Standard Care Total
Hide Arm/Group Description

Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Printed Self-help materials for Smoking Cessation

Total of all reporting groups
Overall Number of Baseline Participants 28 31 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 31 participants 59 participants
53.9  (11.9) 57.1  (8.3) 55.6  (10.2)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 31 participants 59 participants
Female
5
  17.9%
11
  35.5%
16
  27.1%
Male
23
  82.1%
20
  64.5%
43
  72.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 31 participants 59 participants
28 31 59
1.Primary Outcome
Title Smoking Cessation: 7 Day Point Prevalence Abstinence
Hide Description No smoking, not even a puff, for 7 days; verified by carbon monoxide measurement. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BA for Cardiac Patients Who Smoke Standard Care
Hide Arm/Group Description:

Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Printed Self-help materials for Smoking Cessation

Overall Number of Participants Analyzed 28 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.46
(0.28 to 0.64)
0.44
(0.26 to 0.62)
2.Primary Outcome
Title Continuous Abstinence From Smoking Since Discharge
Hide Description Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BA for Cardiac Patients Who Smoke Standard Care
Hide Arm/Group Description:

Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Printed Self-help materials for Smoking Cessation

Overall Number of Participants Analyzed 28 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.38
(0.20 to 0.56)
0.34
(0.18 to 0.50)
3.Primary Outcome
Title Time to Smoking Relapse
Hide Description 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. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BA for Cardiac Patients Who Smoke Standard Care
Hide Arm/Group Description:

Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Printed Self-help materials for Smoking Cessation

Overall Number of Participants Analyzed 28 31
Mean (Standard Error)
Unit of Measure: Days
71.2  (17.2) 47.4  (8.7)
4.Primary Outcome
Title Time to Smoking Lapse
Hide Description Time in days to first lapse (i.e., first puff of a cigarette) after discharge, which were determined through timeline follow back interviewing. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BA for Cardiac Patients Who Smoke Standard Care
Hide Arm/Group Description:

Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Printed Self-help materials for Smoking Cessation

Overall Number of Participants Analyzed 28 31
Mean (Standard Error)
Unit of Measure: Days
62.4  (13.8) 31.8  (6.5)
5.Secondary Outcome
Title Depression: 9 Item Patient Health Questionnaire (PHQ-9)
Hide Description The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BA for Cardiac Patients Who Smoke Standard Care
Hide Arm/Group Description:

Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Printed Self-help materials for Smoking Cessation

Overall Number of Participants Analyzed 28 31
Mean (Standard Error)
Unit of Measure: units on a scale
Adjusted PHQ-9 Baseline 6.33  (2.10) 6.98  (1.77)
Adjusted PHQ-9 6 months 3.34  (2.62) 6.08  (2.35)
6.Secondary Outcome
Title Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD)
Hide Description The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BA for Cardiac Patients Who Smoke Standard Care
Hide Arm/Group Description:

Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Printed Self-help materials for Smoking Cessation

Overall Number of Participants Analyzed 28 31
Mean (Standard Error)
Unit of Measure: units on a scale
Adjusted CESD Baseline 10.36  (1.31) 11.72  (1.23)
Adjusted CESD 6 months 5.57  (1.06) 6.93  (1.03)
7.Secondary Outcome
Title Positive Affect
Hide Description 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 in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BA for Cardiac Patients Who Smoke Standard Care
Hide Arm/Group Description:

Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Printed Self-help materials for Smoking Cessation

Overall Number of Participants Analyzed 28 31
Mean (Standard Error)
Unit of Measure: units on a scale
Adjusted PANAS-Positive Baseline 13.47  (0.68) 14.56  (0.47)
Adjusted PANAS-Positive 6 months 16.85  (1.66) 15.79  (1.52)
8.Secondary Outcome
Title Negative Affect
Hide Description 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 in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BA for Cardiac Patients Who Smoke Standard Care
Hide Arm/Group Description:

Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Printed Self-help materials for Smoking Cessation

Overall Number of Participants Analyzed 28 31
Mean (Standard Error)
Unit of Measure: units on a scale
Adjusted PANAS-Negative Baseline 9.63  (0.91) 7.62  (0.75)
Adjusted PANAS-Negative 6 months 7.41  (1.41) 8.14  (0.87)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BA for Cardiac Patients Who Smoke Standard Care
Hide Arm/Group Description

Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines

Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Printed Self-help materials for Smoking Cessation

All-Cause Mortality
BA for Cardiac Patients Who Smoke Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
BA for Cardiac Patients Who Smoke Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/31 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BA for Cardiac Patients Who Smoke Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/31 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrew Busch PhD
Organization: The Miriam Hospital
Phone: 4017938189
EMail: andrew_busch@brown.edu
Layout table for additonal information
Responsible Party: Andrew Busch, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01964898    
Other Study ID Numbers: 5K23HL107391 ( U.S. NIH Grant/Contract )
First Submitted: October 15, 2013
First Posted: October 17, 2013
Results First Submitted: October 5, 2016
Results First Posted: January 12, 2017
Last Update Posted: January 12, 2017