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Interactive Voice Response Telephone Technology for the Treatment of Smoking in Patients With Heart Disease

An Interactive, Voice Response-Mediated, Follow-up and Triage System for Smoking Cessation in Smokers With Coronary Heart Disease

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00449852
Acronym
IVR
Enrollment
440
Registered
2007-03-21
Start date
2006-07-01
Completion date
2011-02-01
Last updated
2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Randomized Control Trial, Smoking Cessation, Secondary Prevention, Rehabilitation, Counseling

Brief 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. 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).

Interventions

The IVR group will receive a telephone call from the IVR system three, 14, 30, 90, 120 and 150 days after hospital discharge.

Sponsors

Ottawa Heart Institute Research Corporation
Lead SponsorOTHER
Heart and Stroke Foundation of Ontario
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
SINGLE (Caregiver)

Masking description

Research Assistants completing follow up for outcome data at weeks 26 and 52 were blinded to the treatment allocation.

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

1. Patient is currently a smoker (greater than 5 cigarettes per day in the month preceding admission); 2. Patient is 18 years of age and older; 3. 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; 4. Patient has received automatic referral for smoking cessation counseling; 5. Patient is willing to provide informed consent

Exclusion criteria

1. Patient is unable to read and understand English; 2. Patient lives more than 1.5 hours from UOHI; 3. Patient is returning to referring institution/hospital

Design outcomes

Primary

MeasureTime frameDescription
Continuous Abstinence RateBaseline to 26 weeksSelf-reported abstinence from any tobacco product during the time period.

Secondary

MeasureTime frameDescription
Continuous Abstinence Rate27 to 52 weeksSelf-reported abstinence from any tobacco product during the time period.
7-day Point-prevalence Abstinence RatesAt weeks 26 and 52.no smoking (not even a puff) in the preceding 7 days

Countries

Canada

Contacts

STUDY_CHAIRRobert D Reid, PhD.

University of Ottawa Heart Institute, Minto Prevention and Rehabilitation Centre

PRINCIPAL_INVESTIGATORAndrew Pipe, C.M, MD

University of Ottawa Heart Institute, Minto Prevention and Rehabilitation Centre

PRINCIPAL_INVESTIGATORBonnie Quinlan, BSCN

University of Ottawa Heart Institute, Prevention and Rehabilitation Centre

PRINCIPAL_INVESTIGATORHeather Sherrard, BSCN, MHA

Ottawa Heart Institute Research Corporation

Baseline characteristics

Characteristic
Age, Continuous54.6 Years
STANDARD_DEVIATION 9.4
Cigarettes per day
</= 10
31 Participants
Cigarettes per day
11-20
72 Participants
Cigarettes per day
21-30
162 Participants
Cigarettes per day
31+
19 Participants
Cigarettes per day
Unknown
1 Participants
Fagerstrom score for nicotine dependence5.2 score
STANDARD_DEVIATION 2.2
Highest level of education completed
High school
100 Participants
Highest level of education completed
Postsecondary
101 Participants
Highest level of education completed
Primary school
26 Participants
Race and Ethnicity Not Collected0 Participants
Ready to quit within next 30 days188 Participants
Reason for hospital admission
Acute coronary syndrome
254 Participants
Reason for hospital admission
Coronary artery bypass grafting
12 Participants
Reason for hospital admission
Diagnostic catheterization
100 Participants
Reason for hospital admission
Percutaneous coronary intervention
14 Participants
Received cost-free NRT67 Participants
Sex: Female, Male
Female
47 Participants
Sex: Female, Male
Male
153 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
6 / 2165 / 224
other
Total, other adverse events
0 / 2160 / 224
serious
Total, serious adverse events
0 / 2160 / 224

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 1, 2026