Intervention Trial of Culturally-Appropriate Decision Aids for Smoking Cessation
Recruitment status was Not yet recruiting
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.
Tobacco Use Disorder
Behavioral: Smoking Cessation Decision Aids
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Development and Application of Culturally-Appropriate Decision Aids for Smoking Cessation in Korea: a Single Arm Intervention Trial With Historical Control|
- Proportion of Smokers Who Are Prescribed Smoking Cessation Medication [ Time Frame: 1 month after viewing decision aids ] [ Designated as safety issue: No ]Patients at the health screening department are to be targeted for recruitment of the study. Upon their written informed consent, all participants will be provided with decision aids. After 1 month, it will be determined whether any of the participants actually received smoking cessation prescription or not via medical chart audits.
- Abstinence Rate (Point Prevalence) [ Time Frame: 6 months after viewing decision aids ] [ Designated as safety issue: No ]Participants are expected to choose from various treatment choices after initially viewing the decision aids, from no treatment to smoking cessation medication (which is the primary outcome). Participants will also be assessed for their general abstinence rate according to their choices via telephone interview, as the final outcome of the study.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Behavioral: Smoking Cessation Decision Aids
- 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.
- Behavioral only (without aid of medication, advice only)
- Nicotine replacement therapy (according to product info)
- Bupropion (150 mg twice daily, with run-in period)
- Varenicline (1 mg twice daily, 12 weeks, with run-in period).
The decision aids will be developed through: 1) literature review; 2) qualitative interviews with Korean smokers from various backgrounds; 3) expert opinions. They will be in the form of short educational videos (flash), displayed by Apple's iPad.
The decision aids will contain the followings, in proper Korean social and cultural context:
The choices given in the decisions aid will be:
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566097
|Contact: Dong Wook Shin, MD, MBA, DrPHemail@example.com|
|Contact: Beomseok Suh, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Seoul National University Hospital||Not yet recruiting|
|Seoul, Korea, Republic of, 110-744|
|Contact: Dong Wook Shin, MD, MBA, DrPH 82-2-2072-0847 email@example.com|
|Contact: Beomseok Suh, MD 82-11-8889-3140 firstname.lastname@example.org|
|Principal Investigator: Dong Wook Shin, MD, MBA, DrPH|
|Principal Investigator:||Dong Wook Shin, MD, MBA, DrPH||Seoul National University Hospital|