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

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by:
Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier:
NCT00449852
First received: March 19, 2007
Last updated: April 27, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
 Behavioral: Interactive Voice Response
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: An Interactive, Voice Response-Mediated, Follow-up and Triage System for Smoking Cessation in Smokers With Coronary Heart Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ottawa Heart Institute Research Corporation:

Primary Outcome Measures:
  • Biochemically confirmed 7-day point prevalent smoking abstinence [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Use of smoking cessation resources [ Time Frame: 26 & 52 weeks ] [ Designated as safety issue: No ]
  • Self-efficacy in regards to smoking cessation [ Time Frame: 26 & 52 weeks ] [ Designated as safety issue: No ]
  • Patient Satisfaction of the IVR system [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Continuous Abstinence since hospitalization [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Enrollment: 442
Study Start Date: July 2006
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interactive Voice Response Group Behavioral: Interactive Voice Response
The IVR group will receive a telephone call from the IVR system three, 14, 30, 90, 120 and 150 days after hospital discharge.
No Intervention: Usual Care Group

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).

  Eligibility
Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449852

Locations
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y4W
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Heart and Stroke Foundation of Ontario
Investigators
Study Chair: Robert D Reid, PhD. University of Ottawa Heart Institute, Minto Prevention and Rehabilitation Centre
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Robert Reid PhD MBA, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT00449852     History of Changes
Other Study ID Numbers: NA 5845
Study First Received: March 19, 2007
Last Updated: April 27, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Heart Institute Research Corporation:
Randomized Control Trial
Smoking Cessation
Secondary Prevention
Rehabilitation
Counseling

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
 Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on February 27, 2015