Usage, Usability & Effect on Adherence and Clinical Outcomes of Text Message Reminders for Adolescents With Asthma
11 de febrero de 2016 actualizado por: Children's Hospital Medical Center, Cincinnati
Study of the Usage, Usability, Acceptability, and Effect on Adherence and Clinical Outcomes of a Web Based Text Messaging System for Adolescents With Asthma- Phase 2
The purpose of this randomized crossover study is to determine the efficacy of participant designed medication reminders on asthma control, asthma related quality of life,and medication adherence.
In addition, this study will provide data regarding the usage, usability, acceptability of an online system designed for creating text message reminders.
It is hypothesized that the teens receiving text message reminders will report having greater quality of life related to their asthma, a reported increase in the control of their asthma, and increased adherence to their medication regimen compared to those teens that are not receiving the text message reminders.
Descripción general del estudio
Descripción detallada
Adolescents are typically less adept at managing chronic illnesses and adhering to treatment plans than are parents of younger children.
Adolescents are also typically "early adopters" to technological solutions and text messages are integral in today's teen culture.
Text messages are gaining acceptance in health care both as appointment reminders and direct inquiries.
The purpose of this randomized crossover study is to examine the effect of participant designed medication reminders on asthma control, asthma related quality of life, and medication adherence.
In addition, this study will provide data regarding the usage, usability, and acceptability of an online system designed for creating text message reminders.
Tipo de estudio
Intervencionista
Inscripción (Actual)
61
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229
- Cincinnati Children's Hospital Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
12 años a 22 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Between the ages of 12 and 22
- Diagnosis of Persistent Asthma
- Receiving care at Cincinnati Children's Hospital Medical Center or affiliate
- Prescription of a controller medication
- Must have a cell phone that receives text messages
- Asthma is not well-controlled based on ACT score
- English Speaking
Exclusion Criteria:
- No diagnosis of persistent asthma
- Receiving asthma care other than at a Cincinnati Children's Hospital Medical Center or affiliate
- Asthma is well-controlled based on ACT score
- Does not have a cell phone that receives text messages or plans to change phones within the next 6 months
- Is not taking a daily asthma controller medication
- Is currently receiving asthma appointment or medication reminder text messages from another source
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Comparison 1st
Not enrolled in the CMSText website text messaging system during last 3 months of study participation.
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Experimental: Participant 1st
Enrollment in the CMSText website text messaging system during first 3 months of study participation.
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During baseline (Participant 1st Arm) or Month 3 Visit (Comparison 1st Arm), the study staff member will demonstrate for the teen how to log-on to the calendar system and set up reminders.
Teens will be able to set their own reminders and add other reminders in addition to those that are asthma related.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Asthma Control Test (ACT)
Periodo de tiempo: Change from Baseline on ACT at 3 months (1st arm), Change from Baseline on ACT at 6 months (2nd arm)
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The teen will complete the Asthma Control Test (ACT), a validated 5-item Likert scale test that asks them to detail their asthma symptoms.
These are questions consistent with those that would be asked by a clinician (i.e., how many times have you used your fast-acting inhaler in the past four weeks, how often does asthma limit your activities).
The responses to these questions will also be used to calculate the teen's asthma control.
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Change from Baseline on ACT at 3 months (1st arm), Change from Baseline on ACT at 6 months (2nd arm)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Pediatric Quality of Life Scale Version 4.0 Teen Report (ages 13- 18) (PedsQL)
Periodo de tiempo: Change from Baseline on PedsQL at 3 months (1st arm), Change from Baseline on PedsQL at 6 months (2nd arm)
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This assessment measures how much asthma has been a problem for them in the last month (i.e., "It is hard for me to be responsible for my medications.",
"I worry about my asthma.")
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Change from Baseline on PedsQL at 3 months (1st arm), Change from Baseline on PedsQL at 6 months (2nd arm)
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Adherence
Periodo de tiempo: Change from Baseline in Adherence at 3 months (1st arm), Change from Baseline in Adherence at 6 months (2nd arm)
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Adherence to medication regimen will be monitored with the Smartinhaler Tracker developed by Nexus 6 ltd.
It will record the adherence to medication administered through metered-dose inhalers, which include medication such as Qvar and Flovent.
The Smartinhaler records the time and date medications were taken, whether the canister was shaken appropriately prior to inhalation, and how much the medication was inhaled.
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Change from Baseline in Adherence at 3 months (1st arm), Change from Baseline in Adherence at 6 months (2nd arm)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Maria T Britto, M.D., M.P.H., Children's Hospital Medical Center, Cincinnati
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2010
Finalización primaria (Actual)
1 de diciembre de 2012
Finalización del estudio (Actual)
1 de diciembre de 2012
Fechas de registro del estudio
Enviado por primera vez
29 de noviembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
2 de diciembre de 2010
Publicado por primera vez (Estimar)
3 de diciembre de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
12 de febrero de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
11 de febrero de 2016
Última verificación
1 de febrero de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20090445
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .