Trial Outcomes & Findings for Post Acute Coronary Event Smoking Study (NCT NCT01964898)
NCT ID: NCT01964898
Last Updated: 2017-01-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
6 months
Results posted on
2017-01-12
Participant Flow
65 patients were recruited. 1 was found to be ineligible pre-randomization.
Participant milestones
| Measure |
BA for Cardiac Patients Who Smoke
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.
|
Standard Care
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 Study
STARTED
|
31
|
33
|
|
Overall Study
12 Week Assessment
|
25
|
30
|
|
Overall Study
COMPLETED
|
24
|
26
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
BA for Cardiac Patients Who Smoke
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.
|
Standard Care
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 Study
ineligible post-randomization
|
1
|
1
|
|
Overall Study
did not receive the allocated interventi
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Post Acute Coronary Event Smoking Study
Baseline characteristics by cohort
| Measure |
BA for Cardiac Patients Who Smoke
n=28 Participants
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.
|
Standard Care
n=31 Participants
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
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.9 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
57.1 Years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
55.6 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Gender
Female
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Gender
Male
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
31 participants
n=7 Participants
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsNo 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.
Outcome measures
| Measure |
BA for Cardiac Patients Who Smoke
n=28 Participants
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.
|
Standard Care
n=31 Participants
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
|
|---|---|---|
|
Smoking Cessation: 7 Day Point Prevalence Abstinence
|
0.46 proportion of participants
Interval 0.28 to 0.64
|
0.44 proportion of participants
Interval 0.26 to 0.62
|
PRIMARY outcome
Timeframe: 6 monthsResults are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
Outcome measures
| Measure |
BA for Cardiac Patients Who Smoke
n=28 Participants
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.
|
Standard Care
n=31 Participants
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
|
|---|---|---|
|
Continuous Abstinence From Smoking Since Discharge
|
0.38 proportion of participants
Interval 0.2 to 0.56
|
0.34 proportion of participants
Interval 0.18 to 0.5
|
PRIMARY outcome
Timeframe: 6 monthsTime 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.
Outcome measures
| Measure |
BA for Cardiac Patients Who Smoke
n=28 Participants
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.
|
Standard Care
n=31 Participants
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
|
|---|---|---|
|
Time to Smoking Relapse
|
71.2 Days
Standard Error 17.2
|
47.4 Days
Standard Error 8.7
|
PRIMARY outcome
Timeframe: 6 monthsTime 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.
Outcome measures
| Measure |
BA for Cardiac Patients Who Smoke
n=28 Participants
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.
|
Standard Care
n=31 Participants
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
|
|---|---|---|
|
Time to Smoking Lapse
|
62.4 Days
Standard Error 13.8
|
31.8 Days
Standard Error 6.5
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsThe 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.
Outcome measures
| Measure |
BA for Cardiac Patients Who Smoke
n=28 Participants
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.
|
Standard Care
n=31 Participants
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
|
|---|---|---|
|
Depression: 9 Item Patient Health Questionnaire (PHQ-9)
Adjusted PHQ-9 Baseline
|
6.33 units on a scale
Standard Error 2.10
|
6.98 units on a scale
Standard Error 1.77
|
|
Depression: 9 Item Patient Health Questionnaire (PHQ-9)
Adjusted PHQ-9 6 months
|
3.34 units on a scale
Standard Error 2.62
|
6.08 units on a scale
Standard Error 2.35
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsThe 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.
Outcome measures
| Measure |
BA for Cardiac Patients Who Smoke
n=28 Participants
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.
|
Standard Care
n=31 Participants
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
|
|---|---|---|
|
Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD)
Adjusted CESD Baseline
|
10.36 units on a scale
Standard Error 1.31
|
11.72 units on a scale
Standard Error 1.23
|
|
Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD)
Adjusted CESD 6 months
|
5.57 units on a scale
Standard Error 1.06
|
6.93 units on a scale
Standard Error 1.03
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsAs 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
Outcome measures
| Measure |
BA for Cardiac Patients Who Smoke
n=28 Participants
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.
|
Standard Care
n=31 Participants
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
|
|---|---|---|
|
Positive Affect
Adjusted PANAS-Positive Baseline
|
13.47 units on a scale
Standard Error 0.68
|
14.56 units on a scale
Standard Error 0.47
|
|
Positive Affect
Adjusted PANAS-Positive 6 months
|
16.85 units on a scale
Standard Error 1.66
|
15.79 units on a scale
Standard Error 1.52
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsAs 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.
Outcome measures
| Measure |
BA for Cardiac Patients Who Smoke
n=28 Participants
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.
|
Standard Care
n=31 Participants
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
|
|---|---|---|
|
Negative Affect
Adjusted PANAS-Negative Baseline
|
9.63 units on a scale
Standard Error 0.91
|
7.62 units on a scale
Standard Error 0.75
|
|
Negative Affect
Adjusted PANAS-Negative 6 months
|
7.41 units on a scale
Standard Error 1.41
|
8.14 units on a scale
Standard Error 0.87
|
Adverse Events
BA for Cardiac Patients Who Smoke
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place