Cigarette SmokingNCT01566097
Intervention Trial of Culturally-Appropriate Decision Aids for Smoking Cessation
A study testing Smoking Cessation Decision Aids in people with Cigarette Smoking and Tobacco Use Disorder, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Despite the establishment of various smoking cessation methods, including pharmacological intervention, only a small proportion of smokers who visit doctors choose to receive such assistance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking, Tobacco Use Disorder, Nicotine Dependence
- What is being tested?
- Smoking Cessation Decision Aids
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to Jul 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being age 18 years or older
- having smoked at least one puff in past 7 days
Who cannot join
- current enrollment in other substance abuse treatment program
- being pregnant
- being unable to communicate in Korean
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
Official title: Development and Application of Culturally-Appropriate Decision Aids for Smoking Cessation in Korea: a Single Arm Intervention Trial With Historical Control
Despite the establishment of various smoking cessation methods, including pharmacological intervention, only a small proportion of smokers who visit doctors choose to receive such assistance. Such under-utilization is especially apparent in some cultures, as in the case of Korea, where a government survey showed that only 0.5% of current or formal smoker reported they had been prescribed smoking cessation medication. Shame in asking for help for an addictive disorder has been recognized as one of the most recognized cultural barrier in Asian-American population. It is clear that culturally focused studies on smoking cessation is warranted.
Patient decision aids are tools that help people become involved in decision making by providing information about the options and outcomes and by clarifying personal values. Patient decision aids have been developed to help patients decide whether to quit smoking or not, or whether to use smoking medication or not. However, such previous studies have only been focused on western populations.
The main purpose of this study is to develop a culturally appropriate decision aid for smoking cessation for the Korean population, as well as evaluate its effect on their decision to use smoking cessation medication. The investigators expect that culturally tailored smoking cessation decision aids would increase knowledge about efficacy of smoking cessation, make people have more positive attitudes toward smoking cessation medication, encourage people to discuss about smoking cessation medication with their physicians. Ultimately the investigators expect it would increase usage of smoking cessation medication and enhance the quitting rate of smoking, which is a very important clinical issue.
Read the detailed description
Reluctance to use smoking cessation medication has been identified as most important barriers to successful smoking cessation in the general population. While pharmacologic intervention, especially prescription drug, is recommended by the guideline as most effective therapy for smoking cessation, only a few smokers who visit doctors take medication reflecting serious underutilization of the pharmacologic intervention. Although it seems to be at least equally effective in Asian population compared with the Western counterpart (Fagerstrom, 2010), data from Korean National Health and Nutrition Examination Survey shows that only 0.5% of current or formal smoker reported they had been prescribed smoking cessation medication, far less than those reported from US, UK, Australia, and Canada.
Culture might also affect the treatment-seeking behavior related to smoking cessation. Data from the tobacco helpline in California showed that about 40 percent of the Asian callers to the tobacco helpline were friends or family members compared to six percent of the calls for non-Asian (Zhu SH, 2002). This suggests that Asian Americans and Pacific Islanders may be less likely to ask for help for themselves or that family members are more likely to ask for help for their loved one. This implicates the need to involve family members in treatment from the very beginning, which is a different concept than that seen in the themes of self reliance and personal responsibility among Western cultures (Fong, 2007). In general, it is recognized that Asian Americans with addictive disorders face several cultural and practical barriers to treatment and the result has been an underutilization of addiction and mental health treatment. For example, shame in asking for help for an addictive disorder is recognized as one of the most recognized cultural barrier in this population (Fong, 2007). A few preliminary interventions were targeted to Asian Americans (for example, Suc Khoe La Vang for Vietnamese American and Lay-led smoking cessation approach for South East Asian men, etc), and provided some preliminary evidence for the effectiveness of such culturally-appropriate smoking cessation intervention (Chen, 2001).
To our knowledge, no research has focused on the cultural aspect of smoking cessation in Korean smokers. Asian's general reluctance to use mental health services, fear of stigma of lack of willpower, family issues might be some hypothesized examples of culture-specific barriers to medication use, in addition to more universal barriers like lack of knowledge of possible treatment options and their efficacy and fear of side effects. Understanding the Korean smoker's perspectives on the way of smoking cessation might be a key to the development of effective smoking cessation intervention in this population. However, there is a lack of detailed research on the Korean smokers' cultural beliefs and attitudes toward the smoking cessation, especially the use of smoking cessation medication.
Patient decision aids are tools that help people become involved in decision making by providing information about the options and outcomes and by clarifying personal values. It promotes shared decision making between the patient and practitioner, saves physician's time, and reduces practice variation. In smoking cessation area, patient decision aids has been developed to help the patients decide on whether to quit smoking or not (NHS, UK), and on whether to use smoking cessation medication or not (Healthwire, US; Willemsen, 2006). However, those decision aids were targeted to the Western population, thus limiting the generalizability of the utility of such tools in the population from other culture. To our best knowledge, there is no decision aid specifically tailored for Korean smokers, and we would like to develop one and evaluate its effect on their decision to use smoking cessation medication through this study.
The primary objectives of this study are: 1) to determine the effectiveness of culturally-tailored smoking cessation decision aids by comparing the proportion of using smoking cessation medication in Korean smokers visiting primary care clinic and health screening center with control, and 2) to identify the factors associated with the decision to use the smoking cessation medication, including sociodemographic, medical, behavioral and cognitive factors, etc. The secondary objective of this study is to determine the smoking cessation rates and use of smoking cessation medication in real world setting and identify the factors associated with smoking cessation.
- Being tested
- Smoking Cessation Decision Aids
- Keywords
- Cluster randomized trial, Decision aids, Culturally-appropriate decision aids
- Medical subject headings
- Cigarette Smoking, Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Cessation Decision AidsDevice
The decision aids were developed through: 1) literature review; 2) qualitative interviews with Korean smokers from various backgrounds; 3) expert opinions. They were in the form of short educational videos (flash), displayed by Apple's iPad.
The decision aids contained the followings, in proper Korean social and cultural context:
- Information on the risk of continued smoking and benefits of cessation
- Messages that address common misbeliefs regarding smoking cessation services and medications
- Information on possible smoking cessation options, their efficacy, side effects, costs, etc.
The choices given in the decisions aid were:
- Behavioral only
- Nicotine replacement therapy
- Bupropion
- Varenicline
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This study is cluster randomized trial, and the randomization level is physician. Current smokers seen by physician allocated into intervention group were provided with Smoking Cessation Decision Aids along with study questionnaires. The intervention was Smoking Cessation Decision Aids provided to current smokers. Receives: Device: Smoking Cessation Decision Aids |
| Control group | No intervention | Current smokers seen by physician allocated into control group were provided with only study questionnaires and usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Smokers Who Are Prescribed Smoking Cessation Medication
Patients who visited primary care clinic and health screening center were to be targeted for recruitment of the study. Current smokers seen by physician allocated into intervention group were provided with Smoking Cessation Decision Aids. The proportion of smokers who are prescribed smoking cessation medication within 1 month after reading Decision Aids will be compared with that of control group. The information will be recruited from medical chart.
Measured: 1 month after viewing decision aids
Secondary outcomes (2)
Abstinence Rate (Point Prevalence)
Participants are assessed for their abstinence rate according to their choices via telephone interview, as the final outcome of the study. The abstinence rate of patients in intervention arm will be compared with that of control arm
Measured: 6 months after viewing decision aids
Proportion of Smokers Who Are Prescribed Smoking Cessation Medication
Participants are expected to choose from various treatment choices after initially viewing the decision aids, from no treatment to smoking cessation medication. Proportion of smokers who are prescribed smoking cessation medication within 6 months after reading Decision Aids will be compared with that of control group. The information are assessed via telephone interview.
Measured: 6 month after viewing decision aids
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2015
- Study completionJul 2015 (estimated)
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 Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Dong Wook Shin, Seoul National University Hospital
- Investigators
- Dong Wook Shin, MD,MBA,DrPH, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566097
- Sponsor's protocol ID
- H-1202-032-397
- Status last verified
- Mar 2015
- First submitted
- 27 Mar 2012
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Buck D, Morgan A. Smoking and quitting with the aid of nicotine replacement therapies in the English adult population. Results from the Health Education Monitoring Survey 1995. Eur J Public Health. 2001 Jun;11(2):211-7. doi: 10.1093/eurpub/11.2.211.
PubMed 11420814Willemsen MC, Wiebing M, van Emst A, Zeeman G. Helping smokers to decide on the use of efficacious smoking cessation methods: a randomized controlled trial of a decision aid. Addiction. 2006 Mar;101(3):441-9. doi: 10.1111/j.1360-0443.2006.01349.x.
PubMed 16499517
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of Culturally-Appropriate Decision Aids for Smoking Cessation in Korea: a Single Arm Intervention Trial With Historical Control
- ClinicalTrials.gov ID
- NCT01566097
- Acronym / sponsor ID
- H-1202-032-397
- Keywords
- Cluster randomized trial, Decision aids, Culturally-appropriate decision aids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Apr 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jul 2015 (estimated)
- First posted
- 29 Mar 2012 (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.
Despite the establishment of various smoking cessation methods, including pharmacological intervention, only a small proportion of smokers who visit doctors choose to receive such assistance. Such under-utilization is especially apparent in some cultures, as in the case of Korea, where a government survey showed that only 0.5% of current or formal smoker reported they had been prescribed smoking cessation medication. Shame in asking for help for an addictive disorder has been recognized as one of the most recognized cultural barrier in Asian-American population. It is clear that culturally focused studies on smoking cessation is warranted.
Patient decision aids are tools that help people become involved in decision making by providing information about the options and outcomes and by clarifying personal values. Patient decision aids have been developed to help patients decide whether to quit smoking or not, or whether to use smoking medication or not. However, such previous studies have only been focused on western populations.
The main purpose of this study is to develop a culturally appropriate decision aid for smoking cessation for the Korean population, as well as evaluate its effect on their decision to use smoking cessation medication. The investigators expect that culturally tailored smoking cessation decision aids would increase knowledge about efficacy of smoking cessation, make people have more positive attitudes toward smoking cessation medication, encourage people to discuss about smoking cessation medication with their physicians. Ultimately the investigators expect it would increase usage of smoking cessation medication and enhance the quitting rate of smoking, which is a very important clinical issue.
Detailed description
Reluctance to use smoking cessation medication has been identified as most important barriers to successful smoking cessation in the general population. While pharmacologic intervention, especially prescription drug, is recommended by the guideline as most effective therapy for smoking cessation, only a few smokers who visit doctors take medication reflecting serious underutilization of the pharmacologic intervention. Although it seems to be at least equally effective in Asian population compared with the Western counterpart (Fagerstrom, 2010), data from Korean National Health and Nutrition Examination Survey shows that only 0.5% of current or formal smoker reported they had been prescribed smoking cessation medication, far less than those reported from US, UK, Australia, and Canada.
Culture might also affect the treatment-seeking behavior related to smoking cessation. Data from the tobacco helpline in California showed that about 40 percent of the Asian callers to the tobacco helpline were friends or family members compared to six percent of the calls for non-Asian (Zhu SH, 2002). This suggests that Asian Americans and Pacific Islanders may be less likely to ask for help for themselves or that family members are more likely to ask for help for their loved one. This implicates the need to involve family members in treatment from the very beginning, which is a different concept than that seen in the themes of self reliance and personal responsibility among Western cultures (Fong, 2007). In general, it is recognized that Asian Americans with addictive disorders face several cultural and practical barriers to treatment and the result has been an underutilization of addiction and mental health treatment. For example, shame in asking for help for an addictive disorder is recognized as one of the most recognized cultural barrier in this population (Fong, 2007). A few preliminary interventions were targeted to Asian Americans (for example, Suc Khoe La Vang for Vietnamese American and Lay-led smoking cessation approach for South East Asian men, etc), and provided some preliminary evidence for the effectiveness of such culturally-appropriate smoking cessation intervention (Chen, 2001).
To our knowledge, no research has focused on the cultural aspect of smoking cessation in Korean smokers. Asian's general reluctance to use mental health services, fear of stigma of lack of willpower, family issues might be some hypothesized examples of culture-specific barriers to medication use, in addition to more universal barriers like lack of knowledge of possible treatment options and their efficacy and fear of side effects. Understanding the Korean smoker's perspectives on the way of smoking cessation might be a key to the development of effective smoking cessation intervention in this population. However, there is a lack of detailed research on the Korean smokers' cultural beliefs and attitudes toward the smoking cessation, especially the use of smoking cessation medication.
Patient decision aids are tools that help people become involved in decision making by providing information about the options and outcomes and by clarifying personal values. It promotes shared decision making between the patient and practitioner, saves physician's time, and reduces practice variation. In smoking cessation area, patient decision aids has been developed to help the patients decide on whether to quit smoking or not (NHS, UK), and on whether to use smoking cessation medication or not (Healthwire, US; Willemsen, 2006). However, those decision aids were targeted to the Western population, thus limiting the generalizability of the utility of such tools in the population from other culture. To our best knowledge, there is no decision aid specifically tailored for Korean smokers, and we would like to develop one and evaluate its effect on their decision to use smoking cessation medication through this study.
The primary objectives of this study are: 1) to determine the effectiveness of culturally-tailored smoking cessation decision aids by comparing the proportion of using smoking cessation medication in Korean smokers visiting primary care clinic and health screening center with control, and 2) to identify the factors associated with the decision to use the smoking cessation medication, including sociodemographic, medical, behavioral and cognitive factors, etc. The secondary objective of this study is to determine the smoking cessation rates and use of smoking cessation medication in real world setting and identify the factors associated with smoking cessation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Smoking Cessation Decision AidsThis study is cluster randomized trial, and the randomization level is physician. Current smokers seen by physician allocated into intervention group were provided with Smoking Cessation Decision Aids along with study questionnaires. The intervention was Smoking Cessation Decision Aids provided to current smokers. |
| Control group | No intervention | –Current smokers seen by physician allocated into control group were provided with only study questionnaires and usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- being age 18 years or older
- having smoked at least one puff in past 7 days
Key exclusion criteria (3 listed)
- current enrollment in other substance abuse treatment program
- being pregnant
- being unable to communicate in Korean
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 |
|---|---|---|
| Smoking Cessation Decision AidsThe decision aids were developed through: 1) literature review; 2) qualitative interviews with Korean smokers from various backgrounds; 3) expert opinions. They were in the form of short educational videos (flash), displayed by Apple's iPad. The decision aids contained the followings, in proper Korean social and cultural context: 1. Information on the risk of continued smoking and benefits of cessation 2. Messages that address common misbeliefs regarding smoking cessation services and medications 3. Information on possible smoking cessation options, their efficacy, side effects, costs, etc. The choices given in the decisions aid were: 1. Behavioral only 2. Nicotine replacement therapy 3. Bupropion 4. Varenicline | Device | Intervention group |
Primary outcome
Proportion of Smokers Who Are Prescribed Smoking Cessation Medication
Time frame: 1 month after viewing decision aids
Patients who visited primary care clinic and health screening center were to be targeted for recruitment of the study. Current smokers seen by physician allocated into intervention group were provided with Smoking Cessation Decision Aids. The proportion of smokers who are prescribed smoking cessation medication within 1 month after reading Decision Aids will be compared with that of control group. The information will be recruited from medical chart.
2 secondary outcomes
Abstinence Rate (Point Prevalence)
Time frame: 6 months after viewing decision aids
Proportion of Smokers Who Are Prescribed Smoking Cessation Medication
Time frame: 6 month after viewing decision aids
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
- Results publication: PubMed 11420814Buck D, Morgan A. Smoking and quitting with the aid of nicotine replacement therapies in the English adult population. Results from the Health Education Monitoring Survey 1995. Eur J Public Health. 2001 Jun;11(2):211-7. doi: 10.1093/eurpub/11.2.211.
- Results publication: PubMed 16499517Willemsen MC, Wiebing M, van Emst A, Zeeman G. Helping smokers to decide on the use of efficacious smoking cessation methods: a randomized controlled trial of a decision aid. Addiction. 2006 Mar;101(3):441-9. doi: 10.1111/j.1360-0443.2006.01349.x.
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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.
Dong Wook Shin, MD,MBA,DrPH principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking Cessation Decision Aids in people with Cigarette Smoking and Tobacco Use Disorder, run by Seoul National University Hospital at 1 site in South Korea.
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 3 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: status not confirmed, as of the sponsor's last update on 26 Mar 2015. 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 South Korea. 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?
Results are not available in the source record.
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?
Proportion of Smokers Who Are Prescribed Smoking Cessation Medication (time frame: 1 month after viewing decision aids). 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 NCT01566097, 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 26 Mar 2015.