- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00563199
A Randomized Controlled Trial of a Nurse Delivered Stage-matched Smoking Cessation Intervention to Promote Heart Health of Cardiac Patients
June 14, 2011 updated by: Hospital Authority, Hong Kong
This study is a randomized controlled trial designed to evaluate the effectiveness of a nurse delivered stage-matched intervention to cardiac patients for cessation of tobacco use.
Review of literature shows that there is a clear lack of empirical evidence on (1) using nurses to deliver stage-matched smoking cessation interventions, and (2) the effectiveness of such intervention for cardiac patients in Chinese populations.
The ultimate goal of the intervention achieve a higher quit rate in the intervention group than in the controls.
In addition, the change in the patient's smoking behaviour such as reduction of the number of cigarettes smoked, and progression to a higher stage of readiness to quit, will also be measured.
This study is the first step to address the urgently needed data for (1) promoting the delivery of nurse-run stage-matched smoking cessation interventions to help patients stop smoking, (2) developing smoking cessation policy and programmes in the hospitals and for the health care system, and (3) contributing an evidence-based approach to orientate clinical services towards prevention, so as to reduce premature deaths and the enormous disease burden of our society.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1824
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Hong Kong, China
- Queen Elizabeth Hospital
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Hong Kong, China
- Queen Mary Hospital
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Hong Kong, China
- Tuen Mun Hospital
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Hong Kong, China
- Pamela Youde Nethersole Eastern Hospital
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Hong Kong, China
- Caritas Medical Centre
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Hong Kong, China
- Princess Margaret Hospital
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Hong Kong, China
- United Christian Hospital
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Hong Kong, China
- Tseung Kwan O Hospital
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Hong Kong, China
- Ruttonjee Hospital / Tang Shiu Kin Hospital
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Hong Kong, China
- Tung Wah Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient who is admitted to the participating centres and is a current smoker who has smoked daily in the past 7 days prior to hospitalization.
- Patient speaks and reads Cantonese/Chinese
Exclusion Criteria:
- Patient who is clinically too ill and not suitable to complete questionnaire and/or receive intervention.
- Patient who does not speak or read Chinese
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quitting--to achieve higher quit rate in the cardiac patients (coronary artery disease) who are smokers
Time Frame: continuous abstinence for one month at the time of 3, 6 and 12 month follow up
|
continuous abstinence for one month at the time of 3, 6 and 12 month follow up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reduction of the number of cigarettes smoked
Time Frame: at the time of 3, 6 and 12 month follow up
|
at the time of 3, 6 and 12 month follow up
|
|
Progression to a higher stage of readiness to quit
Time Frame: at the time of 3, 6 and 12 month follow up
|
at the time of 3, 6 and 12 month follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sophia SC Chan, Dr, Department of Nursing Studies, The University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2002
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
November 21, 2007
First Submitted That Met QC Criteria
November 21, 2007
First Posted (Estimate)
November 26, 2007
Study Record Updates
Last Update Posted (Estimate)
June 16, 2011
Last Update Submitted That Met QC Criteria
June 14, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NTWC/CREC/325/04
- HARECCTR0500022
- HKU 7224/01M
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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-
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University of BernUniversity of Zurich; Swiss National Science Foundation; University of Lausanne; University of Geneva, Switzerland and other collaboratorsCompleted
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University of BernUniversity of Zurich; Swiss National Science Foundation; University of Lausanne; University of Geneva, Switzerland and other collaboratorsCompletedSmoking Cessation | ToxicitySwitzerland