Trial Outcomes & Findings for Interactive Voice Response Telephone Technology for the Treatment of Smoking in Patients With Heart Disease (NCT NCT00449852)
NCT ID: NCT00449852
Last Updated: 2026-06-30
Results Overview
Self-reported abstinence from any tobacco product during the time period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
440 participants
Primary outcome timeframe
Baseline to 26 weeks
Results posted on
2026-06-30
Participant Flow
Participant milestones
| Measure |
Interactive Voice Response Group
Participants received automated telephone calls at Days 3, 14, 30, 30, 90, 120, 150, and 180 after hospitalization in addition to the in-hospital counseling with a trained nurse counsellor with a standardized flowsheet and written smoking cessation information.
|
Usual Care Group
Participants received in-hospital counseling from a trained nurse-coordinator, guided by a standardized flowsheet and were provided written information about smoking cessation.
|
|---|---|---|
|
Overall Study
STARTED
|
216
|
224
|
|
Overall Study
Analyzed
|
200
|
210
|
|
Overall Study
COMPLETED
|
95
|
100
|
|
Overall Study
NOT COMPLETED
|
121
|
124
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participants who died or moved to an untraceable address during treatment were removed from analysis.
Baseline characteristics by cohort
| Measure |
Interactive Voice Response Group
n=200 Participants
Participants received automated telephone calls at Days 3, 14, 30, 30, 90, 120, 150, and 180 after hospitalization in addition to the in-hospital counseling with a trained nurse counsellor with a standardized flowsheet and written smoking cessation information.
|
Usual Care Group
n=210 Participants
Participants received in-hospital counseling from a trained nurse-coordinator, guided by a standardized flowsheet and were provided written information about smoking cessation.
|
Total
n=410 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.9 Years
STANDARD_DEVIATION 8.4 • n=200 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
54.6 Years
STANDARD_DEVIATION 9.4 • n=210 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
54.2 Years
STANDARD_DEVIATION 8.9 • n=410 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
|
Sex: Female, Male
Female
|
47 Participants
n=200 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
58 Participants
n=210 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
105 Participants
n=410 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
|
Sex: Female, Male
Male
|
153 Participants
n=200 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
152 Participants
n=210 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
305 Participants
n=410 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Highest level of education completed
Postsecondary
|
93 Participants
n=200 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
101 Participants
n=210 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
194 Participants
n=410 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
|
Highest level of education completed
High school
|
100 Participants
n=200 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
90 Participants
n=210 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
190 Participants
n=410 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
|
Highest level of education completed
Primary school
|
7 Participants
n=200 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
19 Participants
n=210 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
26 Participants
n=410 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
|
Reason for hospital admission
Acute coronary syndrome
|
122 Participants
n=200 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
132 Participants
n=210 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
254 Participants
n=410 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
|
Reason for hospital admission
Diagnostic catheterization
|
52 Participants
n=200 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
48 Participants
n=210 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
100 Participants
n=410 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
|
Reason for hospital admission
Percutaneous coronary intervention
|
14 Participants
n=200 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
16 Participants
n=210 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
30 Participants
n=410 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
|
Reason for hospital admission
Coronary artery bypass grafting
|
12 Participants
n=200 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
14 Participants
n=210 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
26 Participants
n=410 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
|
Cigarettes per day
</= 10
|
31 Participants
n=200 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
33 Participants
n=210 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
64 Participants
n=410 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
|
Cigarettes per day
11-20
|
65 Participants
n=200 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
72 Participants
n=210 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
137 Participants
n=410 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
|
Cigarettes per day
21-30
|
84 Participants
n=200 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
78 Participants
n=210 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
162 Participants
n=410 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
|
Cigarettes per day
31+
|
19 Participants
n=200 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
26 Participants
n=210 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
45 Participants
n=410 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
|
Cigarettes per day
Unknown
|
1 Participants
n=200 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
1 Participants
n=210 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
2 Participants
n=410 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
|
Fagerstrom score for nicotine dependence
|
5.2 score
STANDARD_DEVIATION 2.2 • n=200 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
5.1 score
STANDARD_DEVIATION 2.2 • n=210 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
5.1 score
STANDARD_DEVIATION 2.2 • n=410 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
|
Ready to quit within next 30 days
|
188 Participants
n=200 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
203 Participants
n=210 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
391 Participants
n=410 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
|
Received cost-free NRT
|
67 Participants
n=200 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
74 Participants
n=210 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
141 Participants
n=410 Participants • Participants who died or moved to an untraceable address during treatment were removed from analysis.
|
PRIMARY outcome
Timeframe: Baseline to 26 weeksSelf-reported abstinence from any tobacco product during the time period.
Outcome measures
| Measure |
Interactive Voice Response Group
n=200 Participants
Participants received automated telephone calls at Days 3, 14, 30, 30, 90, 120, 150, and 180 after hospitalization in addition to the in-hospital counseling with a trained nurse counsellor with a standardized flowsheet and written smoking cessation information.
|
Usual Care Group
n=210 Participants
Participants received in-hospital counseling from a trained nurse-coordinator, guided by a standardized flowsheet and were provided written information about smoking cessation.
|
|---|---|---|
|
Continuous Abstinence Rate
|
38 Percentage
|
29.5 Percentage
|
SECONDARY outcome
Timeframe: 27 to 52 weeksSelf-reported abstinence from any tobacco product during the time period.
Outcome measures
| Measure |
Interactive Voice Response Group
n=200 Participants
Participants received automated telephone calls at Days 3, 14, 30, 30, 90, 120, 150, and 180 after hospitalization in addition to the in-hospital counseling with a trained nurse counsellor with a standardized flowsheet and written smoking cessation information.
|
Usual Care Group
n=210 Participants
Participants received in-hospital counseling from a trained nurse-coordinator, guided by a standardized flowsheet and were provided written information about smoking cessation.
|
|---|---|---|
|
Continuous Abstinence Rate
|
34.5 Percentage
|
28.6 Percentage
|
SECONDARY outcome
Timeframe: At weeks 26 and 52.no smoking (not even a puff) in the preceding 7 days
Outcome measures
| Measure |
Interactive Voice Response Group
n=200 Participants
Participants received automated telephone calls at Days 3, 14, 30, 30, 90, 120, 150, and 180 after hospitalization in addition to the in-hospital counseling with a trained nurse counsellor with a standardized flowsheet and written smoking cessation information.
|
Usual Care Group
n=210 Participants
Participants received in-hospital counseling from a trained nurse-coordinator, guided by a standardized flowsheet and were provided written information about smoking cessation.
|
|---|---|---|
|
7-day Point-prevalence Abstinence Rates
at 26 weeks
|
42 Precentage
|
36.2 Precentage
|
|
7-day Point-prevalence Abstinence Rates
at 52 weeks
|
40.0 Precentage
|
33.3 Precentage
|
Adverse Events
Interactive Voice Response Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths
Usual Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 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