NCT02966132

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

2.6 years

First QC Date

November 15, 2016

Last Update Submit

May 1, 2020

Conditions

Smoking Cessation

Keywords

Asian AmericanImmigrant HealthDigital Health InterventionFederally Qualified Health Centers

Outcome Measures

Primary Outcomes (2)

  • abstinence

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

    6-month

  • quite attempt

    self-reported 24-hour quit attempts

    6-month

Secondary Outcomes (2)

  • patient-provider discussion

    immediate post-intervention

  • EHR documented 5As

    immediate post-intervention

Study Arms (2)

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.

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

Behavioral: NPA

Interventions

iMDBEHAVIORAL

Interactive video education delivered on a tablet computer

iMD
NPABEHAVIORAL
NPA

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian Health Services

Oakland, California, 94607, United States

Location

Related Publications (1)

  • 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.

    PMID: 30413543DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Thu Quach, PhD

    Asian Health Services

    PRINCIPAL INVESTIGATOR

  • Janice Tsoh, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2016

First Posted

November 17, 2016

Study Start

November 1, 2016

Primary Completion

June 1, 2019

Study Completion

September 1, 2019

Last Updated

May 5, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

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

Locations

US(1)