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Stage Ib Trial of mSMART for Smoking Cessation Medication Adherence (mSMART-Ib)

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ClinicalTrials.gov Identifier: NCT02635919
Recruitment Status : Unknown
Verified April 2018 by Duke University.
Recruitment status was:  Recruiting
First Posted : December 21, 2015
Last Update Posted : April 3, 2018
Sponsor:
Collaborators:
Intelligent Automation, Inc.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE December 17, 2015
First Posted Date  ICMJE December 21, 2015
Last Update Posted Date April 3, 2018
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2015)
  • Adherence to smoking cessation medication as assessed via Medication Event Monitoring System (MEMS) [ Time Frame: Week 12 ]
    The MEMS Cap, placed on the subject's medication bottle, will document the number of times the bottle is opened per day, totalled at the end of study participation.
  • Acceptability of mSMART based on responses to an exit interview [ Time Frame: Week 12 ]
    Acceptability of mSMART will be based on responses to an exit interview at the end of the study (Visit 2). Questionnaire asks for agreement with statements relating to acceptability of the app. Response options will be quantified on a Likert scale (1 = not at all, 2 = somewhat, 3 = moderately, 4 = extremely). Example question: What was your overall satisfaction with mSMART?
  • Feasibility of mSMART based on frequency of participant use of the app [ Time Frame: Week 12 ]
    Feasibility of mSMART will be based on frequency of participant use of the app, totalled at the end of the study.
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2015)
  • Adherence to smoking cessation medication as assessed via Medication Event Monitoring System (MEMS) [ Time Frame: Week 12 ]
    The MEMS Cap, placed on the subject's medication bottle, will document the number of times the bottle is opened per day, totalled at the end of study participation.
  • Acceptability of mSMART [ Time Frame: Week 12 ]
    Acceptability of mSMART will be based on responses to an exit interview at the end of the study (Visit 2). Questionnaire asks for agreement with statements relating to acceptability of the app. Response options will be quantified on a Likert scale (1 = not at all, 2 = somewhat, 3 = moderately, 4 = extremely). Example question: What was your overall satisfaction with mSMART?
  • Feasibility of mSMART [ Time Frame: Week 12 ]
    Feasibility of mSMART will be based on frequency of participant use of the app, totalled at the end of the study.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2015)
  • Adherence to smoking cessation medication indicated by smoking abstinence [ Time Frame: Week 12 ]
    Adherence to smoking cessation medication will be evaluated by assessing a biochemical (salivary) measure of participant's cotinine level at the end of the 12 week intervention period which will assess smoking abstinence.
  • Adherence to smoking cessation medication indicated by mSMART medication event data [ Time Frame: Week 12 ]
    Adherence to smoking cessation medication analyzed using mSMART's medication event data from use of Medication Aide widget (a component of mSMART involving a smartphone camera-based medication identification and identification-based medication event technology developed by Intelligent Automation, Inc.) in the experimental group.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stage Ib Trial of mSMART for Smoking Cessation Medication Adherence
Official Title  ICMJE Stage Ib Trial of mSMART: Mobile Application Based Personalized Solutions and Tools for Medication Adherence of Rx Pills
Brief Summary The primary aim of this study is to conduct a 60-patient feasibility, acceptability, and preliminary efficacy study of mSMART (Mobile App based Personalized Solutions and Tools for Medication Adherence of Rx Pill), a smartphone application ("app") for improving medication adherence among substance users. The investigators will compare 2 groups of cigarette smokers undergoing a quit attempt with varenicline (Chantix): a) an experimental group using the mSMART app on their smartphone and a MEMS Cap (Medication Event Monitoring System, a smart pillbox that will a record a date and time-stamped medication event whenever pill box is opened and closed, and thus allow for primary measurement of medication adherence) and b) a control group using the MEMS Cap and mobile web-based surveys on their smartphone.
Detailed Description Poor medication adherence (a) results in poorer treatment outcome and (b) accounts for $100 to $290 billion in U.S. healthcare costs annually. Therefore, interventions that target medication adherence are increasingly crucial for patient care and cost-effectiveness. Mobile technologies such as smartphones are increasingly ubiquitous and affordable in the U.S., and can be integrated to augment medication adherence. mSMART is a smartphone application that targets medication adherence in substance users. The study team has developed and assessed mSMART in a Stage Ia trial among 9 non-treatment seeking cigarette smokers. mSMART provides psychoeducation about medication (e.g., dosage, benefits, side-effects), assessment of medication compliance and characteristics associated with substance use, provides reminders to take medications, and conducts real-time medication event feedback intervention. The aim of the current study is to extend findings from the Stage Ia trial assessing preliminary feasibility and acceptability of mSMART for cigarette smokers. In the proposed study, the investigators will conduct a Stage Ib for the continued development of mSMART in an occupational wellness setting. This will also include a study of the feasibility, acceptability, and preliminary efficacy of mSMART for treatment seeking cigarette smokers undergoing a quit attempt in an occupational wellness program. A sample of 60 cigarette smokers prescribed varenicline (Chantix) will be randomized to either a control condition (i.e., use of MEMS Cap, a smart pillbox that records instances that the pill bottle is opened) or treatment condition (i.e., use of MEMS Cap and mSMART) over a 12 week treatment period. The primary hypothesis is that the treatment group will achieve higher levels of medication adherence assessed via MEMS Cap. The secondary hypothesis is that the treatment group will also yield lower levels of salivary cotinine at week 12 assessment, indicating higher rates of smoking abstinence relative to the control group. Findings from the current study will inform the continued development of mSMART as an intervention to enhance substance use treatment outcome, including other forms of substance use besides cigarette smoking.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Nicotine Dependence
Intervention  ICMJE Device: mSMART
A smartphone application that targets medication adherence in substance users, providing information and reminders and tracking medication usage and factors interfering with adherence.
Other Names:
  • mSMART app
  • mSMART Smartphone Application
Study Arms  ICMJE
  • Experimental: mSMART
    Smokers in this group will have the mSMART application installed on their smartphones. The mSMART application will provide information about varenicline (Chantix) and reminders when it's time to take the medication.
    Intervention: Device: mSMART
  • No Intervention: Control
    Smokers in this group will not be given the mSMART application.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 18, 2015)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Recently prescribed varenicline (Chantix) with the intention to quit smoking in the next 3 months
  • Has an Android smartphone (using v5.x.x or lollipop) or Apple smartphone (iPhone) Operating System (iOS) (using v6.0)

Exclusion Criteria:

  • Unwillingness to be randomized to either treatment condition
  • Use of only non-cigarette forms of tobacco (i.e., participant is not a cigarette smoker but instead uses other tobacco products)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02635919
Other Study ID Numbers  ICMJE Pro00064767
271201400069C-0-0-1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • Intelligent Automation, Inc.
  • National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: F. Joseph McClernon, Ph.D. Duke University
PRS Account Duke University
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP