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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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")
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.

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 groups in NCT03064724
Study groupRoleWhat they receive
Smoking Cessation GroupExperimentalPatients 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.

  1. Participation Rate

    proportion of eligible participants consent to participate

    Measured: Baseline

  2. 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)
  1. 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

  2. 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

  3. Quit attempt

    self-reported at least one or more 24 hour quit attempts

    Measured: 3-month

  4. 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.

  1. First posted27 Feb 2017
  2. Study startAug 2012
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

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)
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

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.

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Clinical Trial NCT03064724 | AzTrials