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.
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
- 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
- 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.
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.
- Conditions
- Smoking Cessation
- 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 group | Role | What they receive |
|---|---|---|
| iMD | Experimental | Participants 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 |
| NPA | Active comparator | Participants 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.
abstinence
7-day point prevalent smoking abstinence biochemically verified by salivary cotinine
Measured: 6-month
quite attempt
self-reported 24-hour quit attempts
Measured: 6-month
Secondary outcomes (2)
patient-provider discussion
self-reported by patient whether discussion on tobacco use took place at the intervention clinical encounter
Measured: immediate post-intervention
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.
- First posted17 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Asian Health Services
- Responsible party
- Sponsor
- Investigators
- Thu Quach, PhD, Principal investigator, Asian Health ServicesJanice Tsoh, PhD, Principal investigator, University of California, San Francisco
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
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Mobile Doctor (iMD) for Asian Smokers
- ClinicalTrials.gov ID
- NCT02966132
- Acronym / sponsor ID
- iMD / TRDRP 24AT-1301
- Conditions
- Smoking Cessation
- Keywords
- Asian American, Immigrant Health, Digital Health Intervention, Federally Qualified Health Centers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Asian Health Services
- Study start
- Nov 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 17 Nov 2016 (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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iMD | Experimental | Behavioral: iMDParticipants 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. |
| NPA | Active comparator | Behavioral: NPAParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| iMDInteractive video education delivered on a tablet computer | Behavioural | iMD |
| NPA | Behavioural | NPA |
Primary outcome
abstinence
Time frame: 6-month
7-day point prevalent smoking abstinence biochemically verified by salivary cotinine
quite attempt
Time frame: 6-month
self-reported 24-hour quit attempts
2 secondary outcomes
patient-provider discussion
Time frame: immediate post-intervention
EHR documented 5As
Time frame: immediate post-intervention
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 5 May 2020.
- Derived from this study: PubMed 30413543Tsoh 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.
- Individual participant dataSharing planned: No. No plan to make individual participant data available at this time.
Related trials for Smoking Cessation
Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
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Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation
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 principal investigator
Asian Health Services
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 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.