Stage Ib Trial of mSMART for Smoking Cessation Medication Adherence (mSMART-Ib)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence||Device: mSMART||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stage Ib Trial of mSMART: Mobile Application Based Personalized Solutions and Tools for Medication Adherence of Rx Pills|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
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.
A smartphone application that targets medication adherence in substance users, providing information and reminders and tracking medication usage and factors interfering with adherence.
No Intervention: Control
Smokers in this group will not be given the mSMART application.
- 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.
- 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.
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): NCT02635919
|Contact: John Mitchell, Ph.D.||firstname.lastname@example.org|
|Contact: Al Salley, M.A.||email@example.com|
|United States, North Carolina|
|Duke Health Behavior Neuroscience Research Lab||Recruiting|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||F. Joseph McClernon, Ph.D.||Duke University|