Coronary Artery DiseaseIVRNCT00449852
Interactive Voice Response Telephone Technology for the Treatment of Smoking in Patients With Heart Disease
A study testing Interactive Voice Response in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
A randomized control trial is planned to evaluate an interactive voice response (IVR) mediated follow-up and triage system, against usual care, to help smokers hospitalized with Coronary Heart Disease (CHD) to quit smoking. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Interactive Voice Response
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2006to Feb 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is currently a smoker (greater than 5 cigarettes per day in the month preceding admission);
- Patient is 18 years of age and older;
- Patient is admitted to the in-patient cardiology service at the University of Ottawa Heart Institute (UOHI) for: a) Acute Coronary Syndrome (includes patients admitted for unstable angina or acute myocardial infarction), b) Elective Percutaneous Coronary Intervention (PCI), c) Coronary Artery Bypass Graft (CABG) or d) diagnostic catheterization procedures related to CHD;
- Patient has received automatic referral for smoking cessation counseling;
- Patient is willing to provide informed consent
Who cannot join
- Patient is unable to read and understand English;
- Patient lives more than 1.5 hours from UOHI;
- Patient is returning to referring institution/hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interactive, Voice Response-Mediated, Follow-up and Triage System for Smoking Cessation in Smokers With Coronary Heart Disease
A randomized control trial is planned to evaluate an interactive voice response (IVR) mediated follow-up and triage system, against usual care, to help smokers hospitalized with Coronary Heart Disease (CHD) to quit smoking. The investigators hypothesize that compared to usual care, participants in the IVR group will; a) have a significantly higher 7-day point prevalence abstinence rate at 26 and 52 weeks after hospital discharge, b) will have a higher rate of continuous abstinence at 26 and 52 weeks after hospital discharge, c) will use a greater number of proven effective interventions over time, and d) will develop greater self-efficacy with respect to smoking cessation, over time.
Read the detailed description
Quitting smoking appears to be the single most effective intervention or treatment to reduce mortality in patients with Coronary Heart Disease (CHD). However, despite interventions, almost two-thirds of smokers resumed smoking in the year after hospitalization for CHD related illnesses; one-third resumed smoking within one month. A critical challenge for institution-level programs is how to provide consistent patient follow-up and linkage to community-based smoking cessation resources. Interactive voice response (IVR) technology has the potential to improve follow-up with smokers after hospitalization and to enhance triage to clinical support for smoking cessation. IVR uses natural language to place automated out-going calls that can pose questions regarding smoking status and progress with smoking cessation, that is then dropped into a database. A counselor is then able to link with the database and obtain information about the patient's smoking cessation needs and provide support as appropriate. A randomized control trial (RCT) is planned to evaluate whether an IVR system for follow-up and triage helps smokers hospitalized for CHD, quit smoking over 26- and 52-week follow-up periods. Participants are randomized into either a Usual Care or IVR group. Both groups will receive in-patient counseling and offer of nicotine replacement therapy. The IVR group will additionally receive a telephone call from the IVR system three, 14, 30, 60, 90, 120, and 150 days after hospital discharge. Variables that will be assessed at 26 and 52 weeks include: smoking status, both 7-day point-prevalent and continuous abstinence, as well as self-efficacy for smoking cessation, use of effective cessation resources and patient satisfaction (at 26 weeks).
- Conditions
- Coronary Artery Disease
- Being tested
- Interactive Voice Response
- Keywords
- Randomized Control Trial, Smoking Cessation, Secondary Prevention, Rehabilitation, Counseling
- Medical subject headings
- Coronary Artery Disease, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Voice ResponseBehavioural
The IVR group will receive a telephone call from the IVR system three, 14, 30, 90, 120 and 150 days after hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| Interactive Voice Response Group | Experimental | Not described Receives: Behavioral: Interactive Voice Response |
| Usual Care Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Abstinence Rate
Self-reported abstinence from any tobacco product during the time period.
Measured: Baseline to 26 weeks
Secondary outcomes (2)
Continuous Abstinence Rate
Self-reported abstinence from any tobacco product during the time period.
Measured: 27 to 52 weeks
7-day Point-prevalence Abstinence Rates
no smoking (not even a puff) in the preceding 7 days
Measured: At weeks 26 and 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2007 (estimated)
- Study startJul 2006
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Responsible party
- Sponsor
- Investigators
- Robert D Reid, PhD., Study chair, University of Ottawa Heart Institute, Minto Prevention and Rehabilitation CentreAndrew Pipe, C.M, MD, Principal investigator, University of Ottawa Heart Institute, Minto Prevention and Rehabilitation CentreBonnie Quinlan, BSCN, Principal investigator, University of Ottawa Heart Institute, Prevention and Rehabilitation CentreHeather Sherrard, BSCN, MHA, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449852
- Sponsor's protocol ID
- NA 5845
- Acronym
- IVR
- Status last verified
- Apr 2011
- First submitted
- 19 Mar 2007
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Reid RD, Aitken DA, Mullen KA, McDonnell L, Armstrong A, LeBlanc AG, Slovinec-D'Angelo M, Pipe AL. Automated Telephone Follow-up for Smoking Cessation in Smokers With Coronary Heart Disease: A Randomized Controlled Trial. Nicotine Tob Res. 2019 Jul 17;21(8):1051-1057. doi: 10.1093/ntr/nty108.
PubMed 29800420
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interactive, Voice Response-Mediated, Follow-up and Triage System for Smoking Cessation in Smokers With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT00449852
- Acronym / sponsor ID
- IVR / NA 5845
- Conditions
- Coronary Artery Disease
- Keywords
- Randomized Control Trial, Smoking Cessation, Secondary Prevention, Rehabilitation, Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Study start
- Jul 2006
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 21 Mar 2007 (estimated)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized control trial is planned to evaluate an interactive voice response (IVR) mediated follow-up and triage system, against usual care, to help smokers hospitalized with Coronary Heart Disease (CHD) to quit smoking. The investigators hypothesize that compared to usual care, participants in the IVR group will; a) have a significantly higher 7-day point prevalence abstinence rate at 26 and 52 weeks after hospital discharge, b) will have a higher rate of continuous abstinence at 26 and 52 weeks after hospital discharge, c) will use a greater number of proven effective interventions over time, and d) will develop greater self-efficacy with respect to smoking cessation, over time.
Detailed description
Quitting smoking appears to be the single most effective intervention or treatment to reduce mortality in patients with Coronary Heart Disease (CHD). However, despite interventions, almost two-thirds of smokers resumed smoking in the year after hospitalization for CHD related illnesses; one-third resumed smoking within one month. A critical challenge for institution-level programs is how to provide consistent patient follow-up and linkage to community-based smoking cessation resources. Interactive voice response (IVR) technology has the potential to improve follow-up with smokers after hospitalization and to enhance triage to clinical support for smoking cessation. IVR uses natural language to place automated out-going calls that can pose questions regarding smoking status and progress with smoking cessation, that is then dropped into a database. A counselor is then able to link with the database and obtain information about the patient's smoking cessation needs and provide support as appropriate. A randomized control trial (RCT) is planned to evaluate whether an IVR system for follow-up and triage helps smokers hospitalized for CHD, quit smoking over 26- and 52-week follow-up periods. Participants are randomized into either a Usual Care or IVR group. Both groups will receive in-patient counseling and offer of nicotine replacement therapy. The IVR group will additionally receive a telephone call from the IVR system three, 14, 30, 60, 90, 120, and 150 days after hospital discharge. Variables that will be assessed at 26 and 52 weeks include: smoking status, both 7-day point-prevalent and continuous abstinence, as well as self-efficacy for smoking cessation, use of effective cessation resources and patient satisfaction (at 26 weeks).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Voice Response Group | Experimental | Behavioral: Interactive Voice Response |
| Usual Care Group | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is currently a smoker (greater than 5 cigarettes per day in the month preceding admission);
- Patient is 18 years of age and older;
- Patient is admitted to the in-patient cardiology service at the University of Ottawa Heart Institute (UOHI) for: a) Acute Coronary Syndrome (includes patients admitted for unstable angina or acute myocardial infarction), b) Elective Percutaneous Coronary Intervention (PCI), c) Coronary Artery Bypass Graft (CABG) or d) diagnostic catheterization procedures related to CHD;
- Patient has received automatic referral for smoking cessation counseling;
- Patient is willing to provide informed consent
Key exclusion criteria (3 listed)
- Patient is unable to read and understand English;
- Patient lives more than 1.5 hours from UOHI;
- Patient is returning to referring institution/hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Voice ResponseThe IVR group will receive a telephone call from the IVR system three, 14, 30, 90, 120 and 150 days after hospital discharge. | Behavioural | Interactive Voice Response Group |
Primary outcome
Continuous Abstinence Rate
Time frame: Baseline to 26 weeks
Self-reported abstinence from any tobacco product during the time period.
2 secondary outcomes
Continuous Abstinence Rate
Time frame: 27 to 52 weeks
7-day Point-prevalence Abstinence Rates
Time frame: At weeks 26 and 52.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29800420Reid RD, Aitken DA, Mullen KA, McDonnell L, Armstrong A, LeBlanc AG, Slovinec-D'Angelo M, Pipe AL. Automated Telephone Follow-up for Smoking Cessation in Smokers With Coronary Heart Disease: A Randomized Controlled Trial. Nicotine Tob Res. 2019 Jul 17;21(8):1051-1057. doi: 10.1093/ntr/nty108.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D Reid, PhD. study chair
University of Ottawa Heart Institute, Minto Prevention and Rehabilitation Centre
Andrew Pipe, C.M, MD principal investigator
University of Ottawa Heart Institute, Minto Prevention and Rehabilitation Centre
Bonnie Quinlan, BSCN principal investigator
University of Ottawa Heart Institute, Prevention and Rehabilitation Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Voice Response in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Abstinence Rate (time frame: Baseline to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00449852, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.