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

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ClinicalTrials.gov Identifier: NCT02966132
Recruitment Status : Completed
First Posted : November 17, 2016
Last Update Posted : May 5, 2020
Sponsor:
Collaborator:
Asian Health Services
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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 care.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: iMD Behavioral: NPA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interactive Mobile Doctor (iMD) for Asian Smokers
Actual Study Start Date : November 2016
Actual Primary Completion Date : June 2019
Actual Study Completion Date : September 2019

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.
Behavioral: iMD
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
Behavioral: NPA



Primary Outcome Measures :
  1. abstinence [ Time Frame: 6-month ]
    7-day point prevalent smoking abstinence biochemically verified by salivary cotinine

  2. quite attempt [ Time Frame: 6-month ]
    self-reported 24-hour quit attempts


Secondary Outcome Measures :
  1. patient-provider discussion [ Time Frame: immediate post-intervention ]
    self-reported by patient whether discussion on tobacco use took place at the intervention clinical encounter

  2. EHR documented 5As [ Time Frame: immediate post-intervention ]
    EHR progress notes documenting delivery of the clinical guideline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966132


Locations
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United States, California
Asian Health Services
Oakland, California, United States, 94607
Sponsors and Collaborators
University of California, San Francisco
Asian Health Services
Investigators
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Principal Investigator: Thu Quach, PhD Asian Health Services
Principal Investigator: Janice Tsoh, PhD University of California, San Francisco
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02966132    
Other Study ID Numbers: TRDRP 24AT-1301
24AT-1300 ( Other Grant/Funding Number: TRDRP )
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to make individual participant data available at this time.
Keywords provided by University of California, San Francisco:
Asian American
Immigrant Health
Digital Health Intervention
Federally Qualified Health Centers