Intervention Trial of Culturally-Appropriate Decision Aids for Smoking Cessation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Dong Wook Shin, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01566097
First received: March 27, 2012
Last updated: March 25, 2015
Last verified: March 2015
  Purpose

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 Intervention
Cigarette Smoking
Tobacco Use Disorder
Nicotine Dependence
Smoking Cessation
Device: Smoking Cessation Decision Aids

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Proportion of Smokers Who Are Prescribed Smoking Cessation Medication [ Time Frame: 1 month after viewing decision aids ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Abstinence Rate (Point Prevalence) [ Time Frame: 6 months after viewing decision aids ] [ Designated as safety issue: No ]
    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 ] [ 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. 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.


Estimated Enrollment: 400
Study Start Date: April 2012
Estimated Study Completion Date: July 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:

  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
No Intervention: Control group
Current smokers seen by physician allocated into control group were provided with only study questionnaires and usual care.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • being age 18 years or older
  • having smoked at least one puff in past 7 days

Exclusion Criteria:

  • current enrollment in other substance abuse treatment program
  • being pregnant
  • being unable to communicate in Korean
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566097

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Pfizer
Investigators
Principal Investigator: Dong Wook Shin, MD,MBA,DrPH Seoul National University Hospital
  More Information

Publications:
Responsible Party: Dong Wook Shin, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01566097     History of Changes
Other Study ID Numbers: H-1202-032-397
Study First Received: March 27, 2012
Last Updated: March 25, 2015
Health Authority: Korea: Institutional Review Board of Seoul National University Hospital

Keywords provided by Seoul National University Hospital:
Cluster randomized trial
Decision aids
Culturally-appropriate decision aids

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on March 26, 2015