Ignite Creation Date:
2024-05-06 @ 7:55 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02635919
Status:
UNKNOWN
Last Update Posted:
2018-04-03
First Post:
2015-12-17
Brief Title:
Stage Ib Trial of mSMART for Smoking Cessation Medication Adherence
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Stage Ib Trial of mSMART Mobile Application Based Personalized Solutions and Tools for Medication Adherence of Rx Pills
Status:
UNKNOWN
Status Verified Date:
2018-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
mSMART-Ib
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 US 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 US 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 eg 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 ie use of MEMS Cap a smart pillbox that records instances that the pill bottle is opened or treatment condition ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 271201400069C-0-0-1 | NIH | None | httpsreporternihgovquickSearch271201400069C-0-0-1 |