- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00713895
Treating Chinese Smokers With Interactive Expert System
December 7, 2018 updated by: Janice Tsoh, Ph.D., University of California, San Francisco
The research study examined the feasibility, implementation, and efficacy of the interactive expert system intervention for smoking cessation in the Chinese American population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The research study examines the feasibility, implementation, and efficacy of the interactive expert system intervention for smoking cessation in the Chinese American population.
The primary specific aim of the proposed research is to test the following hypotheses: 1) Proactive recruitment approach will be more effective in recruiting smokers who are in precontemplation (no intent to quit smoking in the next 6 months) than a reactive approach.
2) Participants in the experimental condition receiving the interactive stage-matched expert system intervention plus a manual will be more likely to be abstinent at 12 and 18 than those in the control condition receiving a non-interactive standard manual.
3) Participants receiving the interactive expert system intervention will be more likely to report at least one quit attempt than those in the control condition at months 6, 12, and 18. 4) Participants receiving the interactive expert system intervention will be more likely to have a significant decrease in number of cigarettes smoked than those in the control condition at months 3, 6, 12, and 18.
After the intervention adaptation and the pilot testing phase of study procedures, the study will achieve the above aims using a randomized trial targeting 400 Chinese American Smokers with follow-up assessments at 3, 6, 12, and 18 months after baseline.
Study Type
Interventional
Enrollment (Actual)
363
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- UCSF Langley Porter
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- residents of the San Francisco Bay Area
- age 18 or older
- self-identified as Chinese in ethnicity
- able to read English or Chinese
- have smoked at least 100 cigarettes in their lifetime
- currently smoke at least 5 cigarettes in the past 7 days
Exclusion Criteria:
- currently engaging in other smoking cessation efforts.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard Self-Help
receive a standard self-help manual in Chinese and English of the participants' choice at baseline
|
standard smoking cessation self-help manual
|
Experimental: Expert System
receive an expert system intervention that included the Pathway-To-Change self-help manual and a series of 3 individualized feedback reports at baseline, 3, and 6 months.
|
an expert system intervention provided the Pathway-To-Change self-help manual and a series of 3 individualized feedback reports at baseline, 3, and 6 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
abstinence
Time Frame: 18 months
|
self-report 7-day point prevalence abstinence of cigarette use
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quit attempt
Time Frame: 18 months
|
self-report of 24-hour quit attempt
|
18 months
|
reduction
Time Frame: 18 months
|
smoking reduction from baseline
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Janice Tsoh, PhD, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2001
Primary Completion (Actual)
January 1, 2004
Study Completion (Actual)
August 1, 2005
Study Registration Dates
First Submitted
July 9, 2008
First Submitted That Met QC Criteria
July 9, 2008
First Posted (Estimate)
July 14, 2008
Study Record Updates
Last Update Posted (Actual)
December 11, 2018
Last Update Submitted That Met QC Criteria
December 7, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 5K23DA000468 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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