- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02072005
Mobile App Based Personalized Solutions and Tools for Medication Adherence of Rx Pills (mSMART)
Mobile Application Based Personalized Solutions and Tools for Medication Adherence of Rx Pills
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
North Carolina
-
Durham, North Carolina, Förenta staterna, 27705
- Duke University Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Endast fall
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Regular cigarette smokers
|
This application is an interface that provides subjects with information and questionnaires related to their medication.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of alarms emitted by msmart app that subjects respond to.
Tidsram: 7 days
|
Measurement of app feasibility.
|
7 days
|
|
Likert response score
Tidsram: After 7 day observation period.
|
Likert scale responses to a questionnaire completed at follow-up visit. Questionnaire asks for agreement with statements relating to acceptability of the app. Scale:
|
After 7 day observation period.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of study participant attrition.
Tidsram: 7 days
|
Used to assess acceptability of mSMART app.
|
7 days
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: John T Mitchell, Ph.D., Duke University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- Pro00048974
- HHSN271201300022C (Annat bidrag/finansieringsnummer: National Institute on Drug Abuse)
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