Intervention Trial of Culturally-Appropriate Decision Aids for Smoking Cessation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01566097|
Recruitment Status : Unknown
Verified March 2015 by Dong Wook Shin, Seoul National University Hospital.
Recruitment status was: Active, not recruiting
First Posted : March 29, 2012
Last Update Posted : March 26, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Cigarette Smoking Tobacco Use Disorder Nicotine Dependence Smoking Cessation||Device: Smoking Cessation Decision Aids||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development and Application of Culturally-Appropriate Decision Aids for Smoking Cessation in Korea: a Single Arm Intervention Trial With Historical Control|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||February 2015|
|Estimated Study Completion Date :||July 2015|
Experimental: Intervention group
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.
Device: Smoking Cessation Decision Aids
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:
The choices given in the decisions aid were:
No Intervention: Control group
Current smokers seen by physician allocated into control group were provided with only study questionnaires and usual care.
- 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.
- Abstinence Rate (Point Prevalence) [ Time Frame: 6 months after viewing decision aids ]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
- Proportion of Smokers Who Are Prescribed Smoking Cessation Medication [ Time Frame: 6 month after viewing decision aids ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566097
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Principal Investigator:||Dong Wook Shin, MD,MBA,DrPH||Seoul National University Hospital|