Smoking CessationNCT03064724
Practice-based Intervention for Vietnamese and Korean Patients
A study testing Interactive Mobile Doctor ("iMD") in people with Smoking Cessation and Tobacco Use, run by Asian Health Services.
Trial summary
This pilot project examined the feasibility of an multilingual interactive video education intervention "an interactive Mobile Doctor intervention (iMD)" to promote patient-provider discussion on tobacco use for Korean- and Vietnamese-speaking male patients at primary care settings. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Smoking Cessation, Tobacco Use
- What is being tested?
- Interactive Mobile Doctor ("iMD")
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Jul 2015
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- current smokers identified on electronic health records (EHR)
- have a scheduled primary care visit during the recruitment period
Who cannot join
- already quit smoking or not smoking daily in the past 7 days
- had already quit smoking or not smoking daily in the past 7 days
- had canceled or rescheduled their primary care visit outside of the study period
About this study
This pilot project examined the feasibility of an multilingual interactive video education intervention "an interactive Mobile Doctor intervention (iMD)" to promote patient-provider discussion on tobacco use for Korean- and Vietnamese-speaking male patients at primary care settings.
Read the detailed description
While California has made significant strides in tobacco control and is leading the nation in reducing smoking use, the decline is not observed in all groups. Select groups still have much higher smoking rates and thus bear an unequal burden of tobacco-related illnesses and deaths. Of important note, Asian American men as a combined group have a higher smoking rate than non-Hispanic Whites (22% vs. 18%, respectively); in particular, the highest smoking prevalence has been observed in Vietnamese (31%) and Korean (30%) men among major Asian subgroups. Research also shows that smoking rates are higher for Asian American men with low acculturation (e.g., immigrant status, low English proficiency) than for those who are more acculturated; yet the reverse trend is observed in Asian American women. These findings underscore the need for more targeted tobacco control efforts. The scientific literature suggests that provider advice to quit smoking can influence a smoker's decision to quit. However, research has shown that Asian Americans are less likely to receive such provider advice. Providers often have very limited face-time with patients during the short clinic visit, which presents a challenge as to whether they can incorporate smoking cessation messages during the visit. Overall, little research has focused on smoking cessation in the clinic setting, particularly research that focuses on Asian Americans. The purpose of the pilot study was to develop a more streamlined smoking cessation intervention that can be integrated into the clinic visit, especially to maximize the time when patients are waiting to see their providers. The research question was whether providing culturally appropriate video education that includes provider advice and was tailored to a patient's readiness for quitting smoking will increase whether a patient receives smoking cessation education according to the recommended Clinical Practice Guideline and whether this results in a decrease in tobacco use in low-income Vietnamese and Korean patients. Using a community-based participatory research approach, the investigators created the iMD that delivers tailored in-language video messages via a mobile tablet to Korean and Vietnamese male smokers right before their clinic visit with a provider. iMD delivers the "5 A's" and generates a bilingual tailored printout. Participants were Korean- and Vietnamese-speaking patients who self-identify as daily smokers and receive primary care at a federally-qualified health center. This study evaluated the feasibility and acceptability of iMD from the patients' perspectives. This study examined patient-provider discussion on tobacco use from patients' self-report and electronic health record (EHR), and self-reported quit attempts and smoking abstinence at 3 months post iMD visit.
- Conditions
- Smoking Cessation, Tobacco Use
- Being tested
- Interactive Mobile Doctor ("iMD")
- Keywords
- smoking, tobacco use, Asian, patients, provider advice, digital health intervention
- Medical subject headings
- Smoking Cessation, Tobacco Use, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Mobile Doctor ("iMD")Behavioural
iMD delivers tailored interactive video education via a mobile tablet to smoking patients right before their clinic visit with a provider. iMD delivers the "5 A's" (ask, advise, assess, assist, and arrange) and generates a bilingual tailored printout, which aims to increase patient-provider discussion on tobacco use and to promote smoking cessation. This version of iMD delivers the intervention in Korean or Vietnamese languages as preferred by the patient.
| Study group | Role | What they receive |
|---|---|---|
| Smoking Cessation Group | Experimental | Patients received the interactive mobile doctor (iMD) intervention. Receives: Behavioral: Interactive Mobile Doctor ("iMD") |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation Rate
proportion of eligible participants consent to participate
Measured: Baseline
Acceptability
proportion of participants who rated the intervention as moderately to extremely satisfied
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Patient-provider discussion
self-reported by patient whether discussion on tobacco use took place at the indexed clinical encounter
Measured: "through study completion, an average of 1 year
Physician delivery of 5As
EHR-documented physician's delivery of assess, advice, assist, or arrange at the indexed clinical encounter
Measured: "through study completion, an average of 1 year
Quit attempt
self-reported at least one or more 24 hour quit attempts
Measured: 3-month
Abstinence
self-reported 7-day point prevalent smoking abstinence
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study startAug 2012
- Primary completionJul 2015
- Study completionJul 2015
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, Thu Quach, Asian Health Services
- Investigators
- Thu Quach, PhD, MPH, Principal investigator, Asian Health ServicesJanice Tsoh, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064724
- Sponsor's protocol ID
- 21BT-0056
- Status last verified
- Feb 2017
- First submitted
- 20 Feb 2017
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice-based Intervention for Vietnamese and Korean Patients
- ClinicalTrials.gov ID
- NCT03064724
- Acronym / sponsor ID
- 21BT-0056
- Conditions
- Smoking Cessation, Tobacco Use
- Keywords
- smoking, tobacco use, Asian, patients, provider advice, digital health intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Asian Health ServicesUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- Aug 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 27 Feb 2017 (actual)
- 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.
This pilot project examined the feasibility of an multilingual interactive video education intervention "an interactive Mobile Doctor intervention (iMD)" to promote patient-provider discussion on tobacco use for Korean- and Vietnamese-speaking male patients at primary care settings.
Detailed description
While California has made significant strides in tobacco control and is leading the nation in reducing smoking use, the decline is not observed in all groups. Select groups still have much higher smoking rates and thus bear an unequal burden of tobacco-related illnesses and deaths. Of important note, Asian American men as a combined group have a higher smoking rate than non-Hispanic Whites (22% vs. 18%, respectively); in particular, the highest smoking prevalence has been observed in Vietnamese (31%) and Korean (30%) men among major Asian subgroups. Research also shows that smoking rates are higher for Asian American men with low acculturation (e.g., immigrant status, low English proficiency) than for those who are more acculturated; yet the reverse trend is observed in Asian American women. These findings underscore the need for more targeted tobacco control efforts. The scientific literature suggests that provider advice to quit smoking can influence a smoker's decision to quit. However, research has shown that Asian Americans are less likely to receive such provider advice. Providers often have very limited face-time with patients during the short clinic visit, which presents a challenge as to whether they can incorporate smoking cessation messages during the visit. Overall, little research has focused on smoking cessation in the clinic setting, particularly research that focuses on Asian Americans. The purpose of the pilot study was to develop a more streamlined smoking cessation intervention that can be integrated into the clinic visit, especially to maximize the time when patients are waiting to see their providers. The research question was whether providing culturally appropriate video education that includes provider advice and was tailored to a patient's readiness for quitting smoking will increase whether a patient receives smoking cessation education according to the recommended Clinical Practice Guideline and whether this results in a decrease in tobacco use in low-income Vietnamese and Korean patients. Using a community-based participatory research approach, the investigators created the iMD that delivers tailored in-language video messages via a mobile tablet to Korean and Vietnamese male smokers right before their clinic visit with a provider. iMD delivers the "5 A's" and generates a bilingual tailored printout. Participants were Korean- and Vietnamese-speaking patients who self-identify as daily smokers and receive primary care at a federally-qualified health center. This study evaluated the feasibility and acceptability of iMD from the patients' perspectives. This study examined patient-provider discussion on tobacco use from patients' self-report and electronic health record (EHR), and self-reported quit attempts and smoking abstinence at 3 months post iMD visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smoking Cessation Group | Experimental | Behavioral: Interactive Mobile Doctor ("iMD")Patients received the interactive mobile doctor (iMD) intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- current smokers identified on electronic health records (EHR)
- have a scheduled primary care visit during the recruitment period
Key exclusion criteria (3 listed)
- already quit smoking or not smoking daily in the past 7 days
- had already quit smoking or not smoking daily in the past 7 days
- had canceled or rescheduled their primary care visit outside of the study period
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 |
|---|---|---|
| Interactive Mobile Doctor ("iMD")iMD delivers tailored interactive video education via a mobile tablet to smoking patients right before their clinic visit with a provider. iMD delivers the "5 A's" (ask, advise, assess, assist, and arrange) and generates a bilingual tailored printout, which aims to increase patient-provider discussion on tobacco use and to promote smoking cessation. This version of iMD delivers the intervention in Korean or Vietnamese languages as preferred by the patient. | Behavioural | Smoking Cessation Group |
Primary outcome
Participation Rate
Time frame: Baseline
proportion of eligible participants consent to participate
Acceptability
Time frame: through study completion, an average of 1 year
proportion of participants who rated the intervention as moderately to extremely satisfied
4 secondary outcomes
Patient-provider discussion
Time frame: "through study completion, an average of 1 year
Physician delivery of 5As
Time frame: "through study completion, an average of 1 year
Quit attempt
Time frame: 3-month
Abstinence
Time frame: 3-month
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 27 Feb 2017.
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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.
Thu Quach, PhD, MPH principal investigator
Asian Health Services
Janice Tsoh principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Mobile Doctor ("iMD") in people with Smoking Cessation and Tobacco Use, run by Asian Health Services.
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 2 inclusion and 3 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 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Participation Rate (time frame: Baseline). The study lists 2 primary outcomes in all. 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 27 Feb 2017.