NCT00449852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jul 2006

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2007

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
15.4 years until next milestone

Results Posted

Study results publicly available

June 30, 2026

Completed
Last Updated

June 30, 2026

Status Verified

April 1, 2011

Enrollment Period

4.6 years

First QC Date

March 19, 2007

Results QC Date

May 27, 2026

Last Update Submit

June 25, 2026

Conditions

Keywords

Randomized Control TrialSmoking CessationSecondary PreventionRehabilitationCounseling

Outcome Measures

Primary Outcomes (1)

  • Continuous Abstinence Rate

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

    Baseline to 26 weeks

Secondary Outcomes (2)

  • Continuous Abstinence Rate

    27 to 52 weeks

  • 7-day Point-prevalence Abstinence Rates

    At weeks 26 and 52.

Study Arms (2)

Interactive Voice Response Group

EXPERIMENTAL
Behavioral: Interactive Voice Response

Usual Care Group

NO INTERVENTION

Interventions

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

Interactive Voice Response Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Coronary Artery DiseaseSmoking Cessation

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesHealth BehaviorBehavior

Limitations and Caveats

* participants were not blinded and may have sought other support services * The intervention group received the standard treatment and the intervention, so cannot confirm quit rate on each arm * lower consent rate than expected

Results Point of Contact

Title
Dr. Robert Reid
Organization
University of Ottawa Heart Institute

Study Officials

  • Robert D Reid, PhD.

    University of Ottawa Heart Institute, Minto Prevention and Rehabilitation Centre

    STUDY CHAIR
  • Andrew Pipe, C.M, MD

    University of Ottawa Heart Institute, Minto Prevention and Rehabilitation Centre

    PRINCIPAL INVESTIGATOR
  • Bonnie Quinlan, BSCN

    University of Ottawa Heart Institute, Prevention and Rehabilitation Centre

    PRINCIPAL INVESTIGATOR
  • Heather Sherrard, BSCN, MHA

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Research Assistants completing follow up for outcome data at weeks 26 and 52 were blinded to the treatment allocation.
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2007

First Posted

March 21, 2007

Study Start

July 1, 2006

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

June 30, 2026

Results First Posted

June 30, 2026

Record last verified: 2011-04

Locations