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
442

participants targeted

Target at P75+ for phase_2 coronary-artery-disease

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_2 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

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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
Last Updated

April 29, 2011

Status Verified

April 1, 2011

Enrollment Period

4.6 years

First QC Date

March 19, 2007

Last Update Submit

April 27, 2011

Conditions

Coronary Artery Disease

Keywords

Randomized Control TrialSmoking CessationSecondary PreventionRehabilitationCounseling

Outcome Measures

Primary Outcomes (1)

  • Biochemically confirmed 7-day point prevalent smoking abstinence

    52 weeks

Secondary Outcomes (4)

  • Use of smoking cessation resources

    26 & 52 weeks

  • Self-efficacy in regards to smoking cessation

    26 & 52 weeks

  • Patient Satisfaction of the IVR system

    26 weeks

  • Continuous Abstinence since hospitalization

    52 weeks

Study Arms (2)

Interactive Voice Response Group

EXPERIMENTAL
Behavioral: Interactive Voice Response

Usual Care Group

NO INTERVENTION

Interventions

Interactive Voice ResponseBEHAVIORAL

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.

    PMID: 29800420DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseSmoking Cessation

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesHealth BehaviorBehavior

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

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

April 29, 2011

Record last verified: 2011-04

Locations

CA(1)