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

29 juli 2014 bijgewerkt door: Duke University

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

11

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • North Carolina
      • Durham, North Carolina, Verenigde Staten, 27705
        • Duke University Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 50 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Case-Alleen
  • Tijdsperspectieven: Prospectief

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Regular cigarette smokers
This application is an interface that provides subjects with information and questionnaires related to their medication.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of alarms emitted by msmart app that subjects respond to.
Tijdsspanne: 7 days
Measurement of app feasibility.
7 days
Likert response score
Tijdsspanne: 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:

  1. = not at all
  2. = somewhat
  3. = moderately
  4. = extremely (example question: What was your overall satisfaction with mSMART?)
After 7 day observation period.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of study participant attrition.
Tijdsspanne: 7 days
Used to assess acceptability of mSMART app.
7 days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Onderzoekers

  • Hoofdonderzoeker: John T Mitchell, Ph.D., Duke University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2014

Primaire voltooiing (Werkelijk)

1 april 2014

Studie voltooiing (Werkelijk)

1 april 2014

Studieregistratiedata

Eerst ingediend

21 februari 2014

Eerst ingediend dat voldeed aan de QC-criteria

24 februari 2014

Eerst geplaatst (Schatting)

26 februari 2014

Updates van studierecords

Laatste update geplaatst (Schatting)

31 juli 2014

Laatste update ingediend die voldeed aan QC-criteria

29 juli 2014

Laatst geverifieerd

1 juli 2014

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • Pro00048974
  • HHSN271201300022C (Ander subsidie-/financieringsnummer: National Institute on Drug Abuse)

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