Smoking CessationNCT00713895
Treating Chinese Smokers With Interactive Expert System
A study testing Expert System and Standard Self-Help in people with Smoking Cessation, run by University of California, San Francisco at 1 site in United States.
Trial summary
The research study examined the feasibility, implementation, and efficacy of the interactive expert system intervention for smoking cessation in the Chinese American population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Expert System and Standard Self-Help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 363 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- currently engaging in other smoking cessation efforts.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Langley Porter
San Francisco, California, 94143
About this study
The research study examined the feasibility, implementation, and efficacy of the interactive expert system intervention for smoking cessation in the Chinese American population.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Expert System, Standard Self-Help
- Keywords
- smoking cessation, randomized trial, Asian, Chinese American, stages of change
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expert SystemBehavioural
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.
Standard Self-HelpBehavioural
standard smoking cessation self-help manual
| Study group | Role | What they receive |
|---|---|---|
| Standard Self-Help | Active comparator | receive a standard self-help manual in Chinese and English of the participants' choice at baseline Receives: Behavioral: Standard Self-Help |
| Expert System | Experimental | 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. Receives: Behavioral: Expert System |
What is being measured
The primary outcome is the main question the study is designed to answer.
abstinence
self-report 7-day point prevalence abstinence of cigarette use
Measured: 18 months
Secondary outcomes (2)
quit attempt
self-report of 24-hour quit attempt
Measured: 18 months
reduction
smoking reduction from baseline
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startAug 2001
- Primary completionJan 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Janice Tsoh, Ph.D., University of California, San Francisco
- Investigators
- Janice Tsoh, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713895
- Sponsor's protocol ID
- 5K23DA000468
- Other IDs
- 5K23DA000468
- Status last verified
- Dec 2018
- First submitted
- 9 Jul 2008
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Chinese Smokers With Interactive Expert System
- ClinicalTrials.gov ID
- NCT00713895
- Acronym / sponsor ID
- 5K23DA000468
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, randomized trial, Asian, Chinese American, stages of change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2001
- Primary completion
- Jan 2004 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research study examined the feasibility, implementation, and efficacy of the interactive expert system intervention for smoking cessation in the Chinese American population.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Self-Help | Active comparator | Behavioral: Standard Self-Helpreceive a standard self-help manual in Chinese and English of the participants' choice at baseline |
| Expert System | Experimental | Behavioral: Expert Systemreceive 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- currently engaging in other smoking cessation efforts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expert Systeman 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. | Behavioural | Expert System |
| Standard Self-Helpstandard smoking cessation self-help manual | Behavioural | Standard Self-Help |
Primary outcome
abstinence
Time frame: 18 months
self-report 7-day point prevalence abstinence of cigarette use
2 secondary outcomes
quit attempt
Time frame: 18 months
reduction
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Tsoh, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expert System and Standard Self-Help in people with Smoking Cessation, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
abstinence (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.