- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03276767
Comparing SMS and E-mail Reminders in an Online Smoking Cessation Intervention
An RCT Comparing Reminders Sendt by SMS or by E-mail in an Online Smoking Cessation Intervention
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Web- and mobile phone health behavior change interventions, including smoking cessation programs, offer great promise, but little is known about how such interventions should be designed to increase user engagement. The primary purpose of the current study is to compare the effect of SMS-textmessage vs e-mail reminders on user engagement and proportion of reported quit attempts in an online smoking cessation intervention.
The investigators propose a 2-arm RCT with 700 adult study participants that all receive a best practices web-based smoking cessation program designed for use on smart phones (web-app). The intervention includes a ten day preparation phase, in which participants continue smoking. On the eleventh day (and onward) the user will receive a session in which (s)he is asked whether (s)he has quit smoking or not. If not, the user will receive additional treatment sessions until (s)he reports having quit (or dropped out of the study). Each day (for up to 14 days) a new unique session is assigned to the user. However, if the user does not log on to the web-intervention and starts using the session by noon on the second day after assignment, the user will receive a reminder to do so. When a user is to be sent a reminder for the first time, (s)he will be randomized to either receive such reminders by SMS or by e-mail.
The primary outcome is reporting a quit attempt or not. Secondary outcomes include number web-sessions started and completed and time spent navigating sessions after the first reminder is received.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Håvar Brendryen, PhD
- Número de teléfono: +47 99521714
- Correo electrónico: brendryen@gmail.com
Ubicaciones de estudio
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Praha, Chequia
- Aún no reclutando
- Department of Addictology, 1st Faculty of Medicine, Charles University
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Contacto:
- Roman Gabrhelík, PhD
- Correo electrónico: gabrhelik@adiktologie.cz
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Oslo, Noruega
- Reclutamiento
- The Norwegian Centre for Addiction Research
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Contacto:
- Håvar Brendryen, PhD
- Número de teléfono: +47 99521714
- Correo electrónico: brendryen@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 18 years or older
- current smoker
- determined to or considering to quit smoking
- provide valid e-mail address
- provide valid norwegian cell phone number
- complete a baseline questionnaire
- start using the intervention (pushing the next page button one time or more on the first session provided)
- has not logged on to any of the online session within noon on the second day after that particular session was made available
Exclusion Criteria:
- Not starting the first treatment session
- Taking every treatment session on time (no need for reminders, and thus not randomized)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Online intervention with SMS reminder
Reminders will be sendt by SMS-TEXTMESSAGE if users of "Endre" does not log on to an assigned online session by noon on the second day.
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The online intervention, "Endre", a digital smoking cessation counsellor that communicates with the user primarily through interactive web-sessions.
Intervention content is tailored based on user input and individual usage pattern.
Up to 14 unique sessions is assigned to the users during the study period, one each day.
If a user does not start a session by noon on the second day a reminder will be sendt.
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Comparador activo: Online intervention with e-mail reminder
Reminder will be sendt by E-MAIL if users of "Endre" does not log on to an assigned online session by noon on the second day.
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The online intervention, "Endre", a digital smoking cessation counsellor that communicates with the user primarily through interactive web-sessions.
Intervention content is tailored based on user input and individual usage pattern.
Up to 14 unique sessions is assigned to the users during the study period, one each day.
If a user does not start a session by noon on the second day a reminder will be sendt.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Salir del intento
Periodo de tiempo: Dentro de las 6 semanas posteriores al inicio de la primera sesión de la intervención
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El usuario informa de un intento de abandono
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Dentro de las 6 semanas posteriores al inicio de la primera sesión de la intervención
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of sessions completed
Periodo de tiempo: Within 6 weeks after starting the first session of the intervention
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Counted from after first reminder until reported quitting or study dropout (a unique session is made available each day)
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Within 6 weeks after starting the first session of the intervention
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Number of sessions started after first reminder
Periodo de tiempo: Within 6 weeks after starting the first session of the intervention
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Counted from after first reminder until reported quitting or study dropout (a unique session is made available each day)
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Within 6 weeks after starting the first session of the intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Håvar Brendryen, PhD, University of Oslo
Publicaciones y enlaces útiles
Publicaciones Generales
- Holter MT, Johansen A, Brendryen H. How a Fully Automated eHealth Program Simulates Three Therapeutic Processes: A Case Study. J Med Internet Res. 2016 Jun 28;18(6):e176. doi: 10.2196/jmir.5415.
- Kulhanek A, Lukavska K, Gabrhelik R, Novak D, Burda V, Prokop J, Holter MTS, Brendryen H. Comparing Reminders Sent via SMS Text Messaging and Email for Improving Adherence to an Electronic Health Program: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Mar 18;10(3):e31040. doi: 10.2196/31040.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NFR 228158/H10-C
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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