Mobile App Based Personalized Solutions and Tools for Medication Adherence of Rx Pills
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 5/5/2014 |
| Start Date: | February 2014 |
| End Date: | March 2014 |
| Contact: | Liz McIntyre, B.A. |
| Email: | elizabethmargaret67@gmail.com |
| Phone: | 919-681-0029 |
Mobile Application Based Personalized Solutions and Tools for Medication Adherence of Rx Pills
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.
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.
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.
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.
Inclusion Criteria:
- 18-50 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)
Exclusion Criteria:
- 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
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