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Smoking CessationiMDNCT02966132

Interactive Mobile Doctor (iMD) for Asian Smokers

A study testing iMD and NPA in people with Smoking Cessation, run by University of California, San Francisco at 1 site in United States.

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

The primary aim of the proposed study is to conduct a randomized controlled trial (RCT) to evaluate the efficacy of the Interactive Mobile Doctor (iMD) intervention targeting 150 Chinese-, Korean- or Vietnamese-speaking male patients who smoke daily and have a scheduled clinic visit at Asian Health Services primary… Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
iMD and NPA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
1 siteUnited States
Study dates
Nov 2016to Sep 2019
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
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • age 18 or older;
  • male;
  • English, Chinese- (Cantonese), Korean- or Vietnamese-speaking;
  • self-identified as ethnic Chinese, Korean, Vietnamese or Asian
  • current smoker as identified by EHR;
  • have an already scheduled provider visit at Asian Health Services;
  • smoke at least 1 cigarette daily in the last 7 days; and
  • unwilling or unavailable to participate the in study procedures (e.g., to complete a brief post-visit survey right after the visit or by phone) according to the group assignment

Who cannot join

  • Have vision and/or hearing difficulty that prevents the participant from viewing or hearing the intervention video messages and/or completing the assessment in person or by telephone

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Asian Health Services

    Oakland, California, 94607

Other trials in United States

About this study

The primary aim of the proposed study is to conduct a randomized controlled trial (RCT) to evaluate the efficacy of the Interactive Mobile Doctor (iMD) intervention targeting 150 Chinese-, Korean- or Vietnamese-speaking male patients who smoke daily and have a scheduled clinic visit at Asian Health Services primary care.

Read the detailed description

The Asian American population is the fast-growing racial group during 2000 and 2010. Smoking prevalence among that Vietnamese (43%), Chinese (32%), and Korean (27%) men who spoke limited English are disproportionately higher than that of men of all races combined (17%). Thus, some Asian groups, including Chinese, Korean and Vietnamese, have an unequal burden of tobacco-related diseases. Asian Health Services (AHS) is a federally-qualified health center in Alameda County, California, providing services in English and 12 different Asian languages. The vast majority of the patients are Chinese, Vietnamese, and Korean with low income. Because of high smoking rates and associated health impacts on patients and their families, promoting smoking cessation is a health priority for AHS. The Vietnamese Community Health Promotion Project (VCHPP) at UCSF has conducted numerous intervention studies to promote smoking cessation among Asian Americans. Given the shared research interest, AHS and VCHPP have partnered to address smoking in Asian Americans. The partners received a TRDRP pilot Community-Academic Research Award grant to develop an interactive "Mobile Doctor" (iMD) intervention in Korean and Vietnamese languages that delivers video education tailored to patient's responses on a computer tablet during the clinic visit to enhance patient-provider discussion of tobacco use. The primary goal of the proposed study is to evaluate the iMD intervention with an expansion to the Chinese language in its efficacy to promote patient-provider discussion and quitting smoking in Chinese, Korean, and Vietnamese male smokers. The study will enroll 150 AHS Chinese-, Korean- or Vietnamese-speaking patients who smoke daily and have a scheduled clinic visit. Participants will then be assigned (by chance) into either receiving 1) iMD on tobacco or 2) video education on nutrition and physical activity recommendations. Participants will be assessed at: before the scheduled intervention visit, immediately after or within one week of the intervention visit, and 6 months following the intervention visit. Additional data will be obtained from EHR. The investigators anticipate that, when compared to participants receiving usual care alone, those who receive the iMD will be more likely to receive physician advice on their tobacco use both at their intervention visit and at one visit following the intervention visit within 6 months as documented in EHR; and at 6 months follow-up, those receiving the iMD will be more likely to report having been able to quit smoking for at least one day during the study period, and to have reported having quit smoking for at least 7 days with their abstinence status verified using a saliva sample. The long-term goal is to understand effective ways to enhance patient-provider communication in tobacco use and to leverage each clinic encounter in promoting smoking cessation among patients in community health settings.

Being tested
iMD, NPA
Keywords
Asian American, Immigrant Health, Digital Health Intervention, Federally Qualified Health Centers
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iMDBehavioural

    Interactive video education delivered on a tablet computer

  • NPABehavioural

Study groups in NCT02966132
Study groupRoleWhat they receive
iMDExperimentalParticipants will receive interactive "Mobile Doctor" (iMD) intervention in English, Chinese, Korean or Vietnamese languages that delivers video education tailored to patient's responses on a computer tablet during the clinic visit to enhance patient-provider discussion of tobacco use. The iMD intervention implements the 5As (Ask, Advice, Assess, Assist, and Arrange) recommended by the Clinical Practice Guideline for treating tobacco dependence. A summary printout including provider recommendation options, brief summary of smoking status, quit intention and concerns are provided to patients to empower them to discuss tobacco use with their providers.
Receives: Behavioral: iMD
NPAActive comparatorParticipants will receive a video education providing nutrition and physical activity recommendations right before before seeing their providers. A printout summarizing topics presented in the education videos will be provided to the patient
Receives: Behavioral: NPA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. abstinence

    7-day point prevalent smoking abstinence biochemically verified by salivary cotinine

    Measured: 6-month

  2. quite attempt

    self-reported 24-hour quit attempts

    Measured: 6-month

Secondary outcomes (2)
  1. patient-provider discussion

    self-reported by patient whether discussion on tobacco use took place at the intervention clinical encounter

    Measured: immediate post-intervention

  2. EHR documented 5As

    EHR progress notes documenting delivery of the clinical guideline

    Measured: immediate post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionJun 2019
  4. Study completionSep 2019

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02966132
Sponsor's protocol ID
TRDRP 24AT-1301
Other IDs
24AT-1300
Acronym
iMD
Status last verified
May 2020
First submitted
15 Nov 2016
Last updated
5 May 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: No plan to make individual participant data available at this time.

Publications

  • Tsoh JY, Quach T, Duong TB, Sa Nan Park E, Wong C, Huang SM, Nguyen TT. Interactive Mobile Doctor (iMD) to Promote Patient-Provider Discussion on Tobacco Use among Asian American Patients in Primary Care: A Pilot Study. J Am Board Fam Med. 2018 Nov-Dec;31(6):869-880. doi: 10.3122/jabfm.2018.06.180018.

    PubMed 30413543

Questions about this trial

What is this clinical trial studying?

A study testing iMD and NPA 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 8 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 5 May 2020. 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: 6-month). 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?

On the ClinicalTrials.gov record for NCT02966132, which also lists 1 linked publication.

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 5 May 2020.

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