SmokingNCT02660957
Smoking Cessation Among People Attending A&E
A study testing self-determination smoking cessation in people with Smoking, run by The University of Hong Kong at 1 site in China.
Trial summary
The purpose of this study is to test the effectiveness of using a brief, self-determination intervention on smoking cessation (immediate or progressive) for people attending AEDs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- self-determination smoking cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,571 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Mar 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 years or above
- triaged as semi-urgent (level 4) or non-urgent (level 5)
- current smokers, either occasional or daily
- express a willingness to quit smoking
Who cannot join
- poor cognitive state or mental illness
- participation in other smoking cessation programmes or services
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Accident and Emergency, United Christian Hospital
Hong Kong
About this study
Official title: Effectiveness of a Brief, Self-determination Intervention for Smoking Cessation (Immediate or Progressive) Among People Attending Emergency Departments: a Randomised Controlled Trial
The purpose of this study is to test the effectiveness of using a brief, self-determination intervention on smoking cessation (immediate or progressive) for people attending AEDs.
Read the detailed description
Cigarette smoking, which causes serious damage to health resulting in many chronic problems including cancer, heart disease, stroke and lung disease, is the single most important, preventable cause of death and diseases. It is therefore crucial that healthcare professionals should promote smoking cessation and help patients quit. The Hong Kong government and community have put enormous efforts on raising tobacco tax, smoke-free legislation, law enforcement, health promotion campaigns and smoking cessation services. The prevalence of daily cigarette smokers has been decreasing from 23.3% in 1982 to 10.7 % in 2012, which is one of the lowest around the world. Nevertheless, about half of the smokers remain reluctant to even try giving up smoking.
Medical attention at Accident and Emergency Departments (AEDs) of smokers who are in physical discomfort can be developed as an excellent "teachable model" as it provides an invaluable opportunity to initiate smoking cessation. Smokers consulting doctors as an emergency are more liable to change their habits to improve their health. According to the Hospital Authority, about 2 million people attend AEDs in Hong Kong each year, of whom 68% are triaged as semi-urgent (level 4) and non-urgent (level 5). The average waiting time for a medical consultation varies among AEDs, but is generally longer than 30 min for triage level 4 and 1-2 h for level 5 - presenting healthcare professionals with a golden opportunity to advise smokers to quit and on the available smoking cessation programmes while they are waiting. However, most of the cessation programmes, including stage-matched interventions, generally take several to more than 30 minutes to implement and hence are not practicable or feasible in busy clinical settings. Indeed, the most common reason cited by healthcare professionals for being unable to help patients to quit smoking is the lack of time, because they are very busy and cannot spare even a few extra minutes to do so. Other barriers include a lack of training and experience, a lack of confidence in the effectiveness of the interventions, and the absence of incentives and deficiencies in support or requirements by hospital management that these programmes should be implemented. Moreover, our previous smoking cessation projects in outpatient clinics have revealed that many patients are too impatient to undergo a long intervention and some are reluctant to participate for fear that they might miss or experience delays in their medical consultation or other medical procedures. To address such problems, further studies are warranted to develop brief and effective interventions with simple, direct, strong, evidence-based warnings for patients who smoke.
Smoking is addictive and quitting is very difficult, with a high rate of relapse, particularly among those with high nicotine dependency. Our previous smoking cessation projects in outpatient clinics and the community have revealed that many smokers who are reluctant to quit are interested in reducing the number of cigarettes smoked per day. Therefore, another potential option would be to help smokers to reduce the number of cigarettes smoked gradually, with the ultimate goal of complete cessation. Several randomised controlled trials in the West have supported that smoking reduction interventions can help smokers first reduce and eventually quit smoking.
What investigators have achieved to date:
Investigators conducted a 'proof-of-principle' pilot randomised controlled trial on a very brief (<30 s) smoking cessation intervention with a 'one in two smokers will be killed by smoking' warning in medical outpatient clinics in Guangzhou. The results showed that more of the smokers who received this brief advice quit or reduced their smoking than did not. This pilot study suggested that even a very brief intervention on smoking cessation is better than no advice in the 'real world' practice for outpatient clinics. Moreover, the study demonstrated the feasibility and acceptability of the implementation of a very brief smoking cessation programme by healthcare professionals in busy clinical settings. In addition, the findings support the need for large randomised controlled trials of brief or minimal interventions with the 'one in two' warning.
In light of the above purpose, investigators designed a study with an experimental intervention for smoking cessation and a placebo comparator to act as control. Smokers randomly assigned to the intervention group were given a very brief (<30 s) smoking cessation intervention during telephone follow-ups with a 'one in two smokers will be killed by smoking' warning, and a self-help quitting leaflet published by the Hong Kong Council on Smoking and Health plus a series of brief interventions using the AWARD model. Whereas smokers randomly assigned to the placebo control group were given a 'placebo' intervention with a 'placebo booster' during telephone follow-ups (that had the same duration as the intervention), except that the content was about increasing physical activity and fruit and vegetable intake.
- Conditions
- Smoking
- Being tested
- self-determination smoking cessation, placebo comparator
- Keywords
- Smoking cessation
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-determination smoking cessationBehavioural
a self-help quitting leaflet plus a series of brief interventions using the AWARD model
placebo comparatorOther
suggest a healthy life style as a placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| self-determination smoking cessation | Experimental | Subjects in the intervention group will be allowed to select their own schedules of quitting after discussing their situation with the counsellor (quit immediately (QI), or quit progressively (QP) with the ultimate goal of completing cessation over an acceptable period). Subjects in the intervention group will receive a self-help quitting leaflet published by the Hong Kong Council on Smoking and Health plus a series of brief interventions using the AWARD model. Receives: Behavioral: self-determination smoking cessation |
| health life | Placebo comparator | Subjects in the placebo control group will receive a smoking cessation leaflet published by the Hong Kong Council on Smoking and Health (COSH), as will the intervention group. Moreover, subjects in the placebo control group will undergo a similar schedule of telephone follow-up as those in the intervention group. They will receive a 'placebo' intervention with a 'placebo booster' of the same duration on increasing physical activity and fruit and vegetable intake. Receives: Other: placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
smoking quit rate change from baseline at 6-month follow-up between intervention and control group
The primary outcome is biochemically validated abstinence at 6 months.
Measured: 6-month follow-up
Secondary outcomes (5)
smoking quit rate change from baseline at 6-month and 12-month follow-up between intervention and control group
self-reported 7-day point prevalence (pp) quit rate at 6 months and 12 months between the intervention and control group
Measured: 6-month and 12-month follow-up
smoking quit rate change from baseline at 12-month follow-up between intervention and control group
biochemically validated abstinence at 12 months.
Measured: 12-month follow-up
smoking reduction rate change from baseline at 6-month and 12-month follow-up between intervention and control group
self-reported reduction of ≥ 50% in cigarette consumption at 6 and 12 months between the intervention and control group
Measured: 6-month and 12-month follow-up
self-efficacy against tobacco change from baseline at 6-month and 12-month follow-up between intervention and control group
self-efficacy against tobacco at 6 and 12 months follow-up between intervention and control group
Measured: 6-month and 12-month follow-up
quality of life change from baseline at 6-month and 12-month follow-up between intervention and control group
quality of life at 6 and 12 months follow-up between intervention and control group
Measured: 6-month 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 posted21 Jan 2016 (estimated)
- Study startJul 2015
- Primary completionMar 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,571 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. LI William Ho Cheung, The University of Hong Kong
- Investigators
- Ho Cheung William Li, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660957
- Sponsor's protocol ID
- A&E
- Status last verified
- May 2019
- First submitted
- 18 Jan 2016
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Li WHC, Xia W, Wang MP, Cheung DYT, Cheung KY, Wong CKH, Lam TH. Effect of quitting immediately vs progressively on smoking cessation for smokers at emergency department in Hong Kong: A posteriori analysis of a randomized controlled trial. PLoS One. 2023 Jan 26;18(1):e0280925. doi: 10.1371/journal.pone.0280925. eCollection 2023.
PubMed 36701401Li WHC, Ho KY, Wang MP, Cheung DYT, Lam KKW, Xia W, Cheung KY, Wong CKH, Chan SSC, Lam TH. Effectiveness of a Brief Self-determination Theory-Based Smoking Cessation Intervention for Smokers at Emergency Departments in Hong Kong: A Randomized Clinical Trial. JAMA Intern Med. 2020 Feb 1;180(2):206-214. doi: 10.1001/jamainternmed.2019.5176.
PubMed 31790546
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Brief, Self-determination Intervention for Smoking Cessation (Immediate or Progressive) Among People Attending Emergency Departments: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02660957
- Acronym / sponsor ID
- A&E
- Conditions
- Smoking
- Keywords
- Smoking cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,571 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 21 Jan 2016 (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.
The purpose of this study is to test the effectiveness of using a brief, self-determination intervention on smoking cessation (immediate or progressive) for people attending AEDs.
Detailed description
Cigarette smoking, which causes serious damage to health resulting in many chronic problems including cancer, heart disease, stroke and lung disease, is the single most important, preventable cause of death and diseases. It is therefore crucial that healthcare professionals should promote smoking cessation and help patients quit. The Hong Kong government and community have put enormous efforts on raising tobacco tax, smoke-free legislation, law enforcement, health promotion campaigns and smoking cessation services. The prevalence of daily cigarette smokers has been decreasing from 23.3% in 1982 to 10.7 % in 2012, which is one of the lowest around the world. Nevertheless, about half of the smokers remain reluctant to even try giving up smoking.
Medical attention at Accident and Emergency Departments (AEDs) of smokers who are in physical discomfort can be developed as an excellent "teachable model" as it provides an invaluable opportunity to initiate smoking cessation. Smokers consulting doctors as an emergency are more liable to change their habits to improve their health. According to the Hospital Authority, about 2 million people attend AEDs in Hong Kong each year, of whom 68% are triaged as semi-urgent (level 4) and non-urgent (level 5). The average waiting time for a medical consultation varies among AEDs, but is generally longer than 30 min for triage level 4 and 1-2 h for level 5 - presenting healthcare professionals with a golden opportunity to advise smokers to quit and on the available smoking cessation programmes while they are waiting. However, most of the cessation programmes, including stage-matched interventions, generally take several to more than 30 minutes to implement and hence are not practicable or feasible in busy clinical settings. Indeed, the most common reason cited by healthcare professionals for being unable to help patients to quit smoking is the lack of time, because they are very busy and cannot spare even a few extra minutes to do so. Other barriers include a lack of training and experience, a lack of confidence in the effectiveness of the interventions, and the absence of incentives and deficiencies in support or requirements by hospital management that these programmes should be implemented. Moreover, our previous smoking cessation projects in outpatient clinics have revealed that many patients are too impatient to undergo a long intervention and some are reluctant to participate for fear that they might miss or experience delays in their medical consultation or other medical procedures. To address such problems, further studies are warranted to develop brief and effective interventions with simple, direct, strong, evidence-based warnings for patients who smoke.
Smoking is addictive and quitting is very difficult, with a high rate of relapse, particularly among those with high nicotine dependency. Our previous smoking cessation projects in outpatient clinics and the community have revealed that many smokers who are reluctant to quit are interested in reducing the number of cigarettes smoked per day. Therefore, another potential option would be to help smokers to reduce the number of cigarettes smoked gradually, with the ultimate goal of complete cessation. Several randomised controlled trials in the West have supported that smoking reduction interventions can help smokers first reduce and eventually quit smoking.
What investigators have achieved to date:
Investigators conducted a 'proof-of-principle' pilot randomised controlled trial on a very brief (<30 s) smoking cessation intervention with a 'one in two smokers will be killed by smoking' warning in medical outpatient clinics in Guangzhou. The results showed that more of the smokers who received this brief advice quit or reduced their smoking than did not. This pilot study suggested that even a very brief intervention on smoking cessation is better than no advice in the 'real world' practice for outpatient clinics. Moreover, the study demonstrated the feasibility and acceptability of the implementation of a very brief smoking cessation programme by healthcare professionals in busy clinical settings. In addition, the findings support the need for large randomised controlled trials of brief or minimal interventions with the 'one in two' warning.
In light of the above purpose, investigators designed a study with an experimental intervention for smoking cessation and a placebo comparator to act as control. Smokers randomly assigned to the intervention group were given a very brief (<30 s) smoking cessation intervention during telephone follow-ups with a 'one in two smokers will be killed by smoking' warning, and a self-help quitting leaflet published by the Hong Kong Council on Smoking and Health plus a series of brief interventions using the AWARD model. Whereas smokers randomly assigned to the placebo control group were given a 'placebo' intervention with a 'placebo booster' during telephone follow-ups (that had the same duration as the intervention), except that the content was about increasing physical activity and fruit and vegetable intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| self-determination smoking cessation | Experimental | Behavioral: self-determination smoking cessationSubjects in the intervention group will be allowed to select their own schedules of quitting after discussing their situation with the counsellor (quit immediately (QI), or quit progressively (QP) with the ultimate goal of completing cessation over an acceptable period). Subjects in the intervention group will receive a self-help quitting leaflet published by the Hong Kong Council on Smoking and Health plus a series of brief interventions using the AWARD model. |
| health life | Placebo comparator | Other: placebo comparatorSubjects in the placebo control group will receive a smoking cessation leaflet published by the Hong Kong Council on Smoking and Health (COSH), as will the intervention group. Moreover, subjects in the placebo control group will undergo a similar schedule of telephone follow-up as those in the intervention group. They will receive a 'placebo' intervention with a 'placebo booster' of the same duration on increasing physical activity and fruit and vegetable intake. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 18 years or above
- triaged as semi-urgent (level 4) or non-urgent (level 5)
- current smokers, either occasional or daily
- express a willingness to quit smoking
Key exclusion criteria (2 listed)
- poor cognitive state or mental illness
- participation in other smoking cessation programmes or services
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 |
|---|---|---|
| self-determination smoking cessationa self-help quitting leaflet plus a series of brief interventions using the AWARD model | Behavioural | self-determination smoking cessation |
| placebo comparatorsuggest a healthy life style as a placebo comparator | Other | health life |
Primary outcome
smoking quit rate change from baseline at 6-month follow-up between intervention and control group
Time frame: 6-month follow-up
The primary outcome is biochemically validated abstinence at 6 months.
5 secondary outcomes
smoking quit rate change from baseline at 6-month and 12-month follow-up between intervention and control group
Time frame: 6-month and 12-month follow-up
smoking quit rate change from baseline at 12-month follow-up between intervention and control group
Time frame: 12-month follow-up
smoking reduction rate change from baseline at 6-month and 12-month follow-up between intervention and control group
Time frame: 6-month and 12-month follow-up
self-efficacy against tobacco change from baseline at 6-month and 12-month follow-up between intervention and control group
Time frame: 6-month and 12-month follow-up
quality of life change from baseline at 6-month and 12-month follow-up between intervention and control group
Time frame: 6-month 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 21 May 2019.
- Derived from this study: PubMed 36701401Li WHC, Xia W, Wang MP, Cheung DYT, Cheung KY, Wong CKH, Lam TH. Effect of quitting immediately vs progressively on smoking cessation for smokers at emergency department in Hong Kong: A posteriori analysis of a randomized controlled trial. PLoS One. 2023 Jan 26;18(1):e0280925. doi: 10.1371/journal.pone.0280925. eCollection 2023.
- Derived from this study: PubMed 31790546Li WHC, Ho KY, Wang MP, Cheung DYT, Lam KKW, Xia W, Cheung KY, Wong CKH, Chan SSC, Lam TH. Effectiveness of a Brief Self-determination Theory-Based Smoking Cessation Intervention for Smokers at Emergency Departments in Hong Kong: A Randomized Clinical Trial. JAMA Intern Med. 2020 Feb 1;180(2):206-214. doi: 10.1001/jamainternmed.2019.5176.
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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.
Ho Cheung William Li, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-determination smoking cessation in people with Smoking, run by The University of Hong Kong at 1 site 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 4 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 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
smoking quit rate change from baseline at 6-month follow-up between intervention and control group (time frame: 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02660957, which also lists 2 linked publications.
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 21 May 2019.