Interactive Mobile Doctor (iMD) for Asian Smokers (iMD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Oakland, California, United States, 94607
        • Asian Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iMD
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.
Interactive video education delivered on a tablet computer
Active Comparator: NPA
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
abstinence
Time Frame: 6-month
7-day point prevalent smoking abstinence biochemically verified by salivary cotinine
6-month
quite attempt
Time Frame: 6-month
self-reported 24-hour quit attempts
6-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient-provider discussion
Time Frame: immediate post-intervention
self-reported by patient whether discussion on tobacco use took place at the intervention clinical encounter
immediate post-intervention
EHR documented 5As
Time Frame: immediate post-intervention
EHR progress notes documenting delivery of the clinical guideline
immediate post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Thu Quach, PhD, Asian Health Services
  • Principal Investigator: Janice Tsoh, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

November 15, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimate)

November 17, 2016

Study Record Updates

Last Update Posted (Actual)

May 5, 2020

Last Update Submitted That Met QC Criteria

May 1, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • TRDRP 24AT-1301
  • 24AT-1300 (Other Grant/Funding Number: TRDRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to make individual participant data available at this time.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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