Intervention Trial of Culturally-Appropriate Decision Aids for Smoking Cessation
Development and Application of Culturally-Appropriate Decision Aids for Smoking Cessation in Korea: a Single Arm Intervention Trial With Historical Control
1 other identifier
interventional
400
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2012
CompletedFirst Posted
Study publicly available on registry
March 29, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedMarch 26, 2015
March 1, 2015
2.8 years
March 27, 2012
March 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 month after viewing decision aids
Secondary Outcomes (2)
Abstinence Rate (Point Prevalence)
6 months after viewing decision aids
Proportion of Smokers Who Are Prescribed Smoking Cessation Medication
6 month after viewing decision aids
Study Arms (2)
Intervention group
EXPERIMENTALThis 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 INTERVENTIONCurrent smokers seen by physician allocated into control group were provided with only study questionnaires and usual care.
Interventions
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: 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
Eligibility Criteria
You may qualify if:
- being age 18 years or older
- having smoked at least one puff in past 7 days
You may not qualify if:
- current enrollment in other substance abuse treatment program
- being pregnant
- being unable to communicate in Korean
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Pfizercollaborator
Study Sites (1)
Seoul National University Hospital
Seoul, Seoul, 110-744, South Korea
Related Publications (2)
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.
PMID: 11420814RESULTWillemsen 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.
PMID: 16499517RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dong Wook Shin, MD,MBA,DrPH
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 27, 2012
First Posted
March 29, 2012
Study Start
April 1, 2012
Primary Completion
February 1, 2015
Study Completion
July 1, 2015
Last Updated
March 26, 2015
Record last verified: 2015-03