Smoking CessationNCT00563199
A Randomized Controlled Trial of a Nurse Delivered Stage-matched Smoking Cessation Intervention to Promote Heart Health of Cardiac Patients
A study testing nurse-delivered stage-matched smoking cessation counseling in people with Smoking Cessation and Smoking, run by Hospital Authority, Hong Kong at 10 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Smoking Cessation, Smoking
- What is being tested?
- nurse-delivered stage-matched smoking cessation counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,824 participants
- Where
- 10 sitesChina
- Study dates
- Mar 2002to Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient who is clinically too ill and not suitable to complete questionnaire and/or receive intervention.
- Patient who does not speak or read Chinese
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Caritas Medical Centre
Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong
Princess Margaret Hospital
Hong Kong
Queen Elizabeth Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
Ruttonjee Hospital / Tang Shiu Kin Hospital
Hong Kong
Tseung Kwan O Hospital
Hong Kong
Tuen Mun Hospital
Hong Kong
Tung Wah Hospital
Hong Kong
United Christian Hospital
Hong Kong
About this study
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.
- Conditions
- Smoking Cessation, Smoking
- Being tested
- nurse-delivered stage-matched smoking cessation counseling
- Keywords
- smoking cessation, smoking behaviors
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nurse-delivered stage-matched smoking cessation counselingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Quitting--to achieve higher quit rate in the cardiac patients (coronary artery disease) who are smokers
Measured: continuous abstinence for one month at the time of 3, 6 and 12 month follow up
Secondary outcomes (2)
Reduction of the number of cigarettes smoked
Measured: at the time of 3, 6 and 12 month follow up
Progression to a higher stage of readiness to quit
Measured: at the time of 3, 6 and 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startMar 2002
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,824 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- Research Grants Council, Hong Kong
- Investigators
- Sophia SC Chan, Dr, Principal investigator, Department of Nursing Studies, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563199
- Sponsor's protocol ID
- NTWC/CREC/325/04
- Other IDs
- HARECCTR0500022, HKU 7224/01M
- Status last verified
- Jun 2011
- First submitted
- 21 Nov 2007
- Last updated
- 16 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Nurse Delivered Stage-matched Smoking Cessation Intervention to Promote Heart Health of Cardiac Patients
- ClinicalTrials.gov ID
- NCT00563199
- Acronym / sponsor ID
- NTWC/CREC/325/04
- Conditions
- Smoking Cessation, Smoking
- Keywords
- smoking cessation, smoking behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,824 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- Research Grants Council, Hong Kong
- Study start
- Mar 2002
- Study completion
- Dec 2005 (actual)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patient who is clinically too ill and not suitable to complete questionnaire and/or receive intervention.
- Patient who does not speak or read Chinese
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nurse-delivered stage-matched smoking cessation counseling | Behavioural | – |
Primary outcome
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
2 secondary outcomes
Reduction of the number of cigarettes smoked
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophia SC Chan, Dr principal investigator
Department of Nursing Studies, The University of Hong Kong
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nurse-delivered stage-matched smoking cessation counseling in people with Smoking Cessation and Smoking, run by Hospital Authority, Hong Kong at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2011.