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

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

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 weeks

Self-reported abstinence from any tobacco product during the time period.

Outcome measures

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 weeks

Self-reported abstinence from any tobacco product during the time period.

Outcome measures

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

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

Dr. Robert Reid

University of Ottawa Heart Institute

Phone: 6136967000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place