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- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Durham, North Carolina, Estados Unidos, 27705
- Duke University Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Solo caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Regular cigarette smokers
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This application is an interface that provides subjects with information and questionnaires related to their medication.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percentage of alarms emitted by msmart app that subjects respond to.
Periodo de tiempo: 7 days
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Measurement of app feasibility.
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7 days
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Likert response score
Periodo de tiempo: After 7 day observation period.
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Likert scale responses to a questionnaire completed at follow-up visit. Questionnaire asks for agreement with statements relating to acceptability of the app. Scale:
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After 7 day observation period.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percentage of study participant attrition.
Periodo de tiempo: 7 days
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Used to assess acceptability of mSMART app.
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7 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: John T Mitchell, Ph.D., Duke University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- Pro00048974
- HHSN271201300022C (Otro número de subvención/financiamiento: National Institute on Drug Abuse)
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Ensayos clínicos sobre mSMART smartphone application
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Duke UniversityNational Institute on Drug Abuse (NIDA); Intelligent Automation, Inc.DesconocidoDependencia de la nicotinaEstados Unidos
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Anjali Raja BeharelleMediService AGInscripción por invitaciónHipertensión | Adherencia a la medicaciónSuiza
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Collabree AGUniversity Hospital, Basel, SwitzerlandReclutamientoHipertensión | Adherencia a la medicaciónSuiza
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Duke UniversityNational Institute on Drug Abuse (NIDA); Intelligent Automation, Inc.Retirado
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Dokuz Eylul UniversityAún no reclutandoTrastorno de estrés postraumático (TEPT)
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Johns Hopkins Bloomberg School of Public HealthNational Heart, Lung, and Blood Institute (NHLBI); Oakland UniversityReclutamientoMejorar el acceso a alimentos saludables en poblaciones con inseguridad alimentaria en situaciones normales y de emergenciaEstados Unidos