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| Sponsor: | University of Ottawa Heart Institute |
|---|---|
| Collaborator: |
Heart and Stroke Foundation of Ontario |
| Information provided by: | University of Ottawa Heart Institute |
| ClinicalTrials.gov Identifier: | NCT00449852 |
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. We 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 II |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
| Official Title: | An Interactive, Voice Response-Mediated, Follow-up and Triage System for Smoking Cessation in Smokers With Coronary Heart Disease |
| Estimated Enrollment: | 476 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Interactive Voice Response Group: Experimental |
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.
|
| Usual Care Group: No Intervention |
Quitting smoking appears to be the single most effective intervention or treament 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 recieve 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Robert D. Reid, PhD MBA | 613-761-5058 | breid@ottawaheart.ca |
| Contact: Ashley Armstrong, MA (c) | 613-798-5555 ext 19345 | aarmstrong@ottawaheart.ca |
| Canada, Ontario | |
| University of Ottawa Heart Institute | Recruiting |
| Ottawa, Ontario, Canada, K1Y4W | |
| 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 | University of Ottawa Heart Institute |
More Information
| Responsible Party: | University of Ottawa Heart Institute ( Robert Reid PhD MBA ) |
| Study ID Numbers: | NA 5845 |
| Study First Received: | March 19, 2007 |
| Last Updated: | October 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00449852 History of Changes |
| Health Authority: | Canada: Ethics Review Committee |
|
Randomized Control Trial Smoking Cessation Secondary Prevention Rehabilitation Counseling |
|
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |