Mobile App Based Personalized Solutions and Tools for Medication Adherence of Rx Pills
Condition: Cigarette Smoking
Study type: Observational

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.
    

Detailed description: 
      Subjects will be 9 nicotine dependent male and female smokers who take at least one
      prescribed medication regularly. This sample will allow for psychiatric comorbidity, though
      is not required. They will be asked to carry a smartphone for 7 days and use a smartphone
      application, also called an "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.
      The study consists of a Screening Visit (~4½ hours), Training Visit (~1 hour), and 1
      Follow-Up Session (~2 hours). Post the Training visit, subjects will then complete the week
      observation period. During that time, subjects will complete experimenter-prompted
      assessments to assess factors that may interfere with medication adherence (e.g., psychiatric
      symptoms, such as forgetfulness). As part of the 'app', reminders will be sent to subjects to
      take their medication (e.g., the reminders will be programmed to accommodate multiple times a
      day dosing within dosage schedule windows). Subjects will also be provided with an electronic
      pillbox that will dispense the subject's medication over the 7 day observation period. After
      the 7 day period, subjects will return the smartphone at the follow-up visit. Primary outcome
      variable measured will be medication adherence as an indicator of feasibility and
      acceptability of the mSMART app.

      This study is an observational study since participants will already be taking a medication
      prescribed by their own physician. The sample is a non-treatment seeking sample of adult
      cigarette smokers. Participants will not be asked to modify their smoking behavior or
      medication use in any way. Participants will receive two devices (i.e., [1] the smartphone
      with mSMART and [2] GlowCap) over the seven day observation period of smoking behavior and
      medication adherence. The ultimate goal of mSMART is to assist with medication adherence and
      is thus an intervention, although the goal of this study is to assess how acceptable and
      feasible it is in a sample already adherent to their medications. We do not predict any
      changes in smoking behavior or medication adherence once participants are provided with
      mSMART or GlowCap. GlowCap is being used to allow the investigators to measure times at which
      the medications were taken.
    

Intervention name(s): mSMART smartphone application
Intervention type(s): Other
Intervention description(s): This application is an interface that provides subjects with information and questionnaires related to their medication.
Observational model: Case-Only
Time perspective: Prospective
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.