Mobile App Based Personalized Solutions and Tools for Medication Adherence of Rx Pills

NCT02072005 | Completed

• 2 other identifiers: Pro00048974HHSN271201300022C
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to conduct a 9-patient feasibility and acceptability study of mSMART (with future studies focusing on improved medication adherence). The sample will include daily smokers who are already taking a prescribed medication. There will be no change in any medication regimen in this study, and the sample will include smokers either with or without a psychiatric disorder. Subjects will be asked to use a smartphone application, or "app" (i.e. mSMART) that will provide information about their medication and when to take it. Along with smart phone, the participants will be asked to utilize an electronic pillbox (i.e. GlowCap) to further assist with medication compliance.

Conditions

Cigarette Smoking

Outcome Measures

Primary Outcomes (2)

• Percentage of alarms emitted by msmart app that subjects respond to.

  Measurement of app feasibility.

  7 days

• Likert response score

  Likert scale responses to a questionnaire completed at follow-up visit. Questionnaire asks for agreement with statements relating to acceptability of the app. Scale: 1. = not at all 2. = somewhat 3. = moderately 4. = extremely (example question: What was your overall satisfaction with mSMART?)

  After 7 day observation period.

Secondary Outcomes (1)

• Percentage of study participant attrition.

  7 days

Study Arms (1)

Regular cigarette smokers

Other: mSMART smartphone application

Interventions

mSMART smartphone application OTHER

This application is an interface that provides subjects with information and questionnaires related to their medication.

Regular cigarette smokers

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Participants will be 15 adult, nicotine dependent smokers for a target completion sample of 9. Subjects will be allowed to meet criteria for a current comorbid psychiatric disorder (e.g., Attention-Deficit/Hyperactivity Disorder \[ADHD\], Post-Traumatic Stress Disorder, Major Depressive Disorder), though non-psychiatric smokers will be included as well. Participants will be taking some form of prescribed psychiatric medication or nicotine replacement therapy in pill form.

You may qualify if:

• years of age
• Male or female
• Taking a prescribed psychiatric or smoking cessation medication in pill form over the past 30 days
• Self-report smoking at least 5 cigarettes/day
• Provides an afternoon exhaled carbon monoxide reading of at least 5 ppm.
• Cognitive functioning \> 80 as assessed by the Kaufmann Brief Intelligence Test, second edition (KBIT-II)

You may not qualify if:

• Significant and chronic medical problems
• Estimated IQ \< 80 on Kaufmann Brief Intelligence Test, Second Edition
• Meets criteria for any other Axis I Disorder (determined by the Structured Diagnostic Interview for DSM; SCID) that requires intervention and might interfere with study participation
• Current non-nicotine substance abuse or dependence or history within the last 3 months
• Females who are pregnant or attempting to become pregnant

Sponsors & Collaborators

• Duke University: lead
• Intelligent Automation, Inc.: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• John T Mitchell, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 26, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 31, 2014

Record last verified: 2014-07

Locations

US (1)