- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01958398
Brief Alcohol Interventions With Mobile Phone Applications for University Students: A Randomized Controlled Trial
Objectives: This study evaluates the efficacy of two mobile phone applications, Promillekoll and PartyPlanner among university government members at two universities in Stockholm, Sweden. The design is a three-armed randomized controlled design, and outcomes are measured in terms of changes in problematic alcohol use at follow up 7 weeks after study initiation and baseline data gathering. Both the Promillekoll and PartyPlanner apps feature real time registration of alcohol consumption and giving feedback of estimated blood alcohol concentration levels. Both apps inform and warn the user when the estimated alcohol level is above 0.6%, a level set that is below risky consumption levels. PartyPlanner additionally provides the possibility of simulating and planning an alcohol consumption event in advance and later on comparing it with the real time registration at the event.
Method: Participants with problematic alcohol use (AUDIT >7 for men and >5 for women) are randomized into one of three groups: 1. Access to Promillekoll, 2. Access to PartyPlanner and 3. Control group. Outcomes on alcohol use as well as information on the users' satisfaction with the app assigned to them gathered after 7 weeks.
The hypotheses are: 1. The groups receiving the Promillekoll and PartyPlanner interventions will reduce their alcohol use to a larger extent than the control group at follow-up compared to the baseline level. 2. The addition of the possibility to plan events beforehand (PartyPlanner) will lead to an increased decrease in alcohol consumption to only real-time use (Promillekoll).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background Brief interventions via the internet have been shown to reduce university students' alcohol intake. This study tested two smartphone applications (apps) targeting drinking choices on party occasions, with the goal of reducing problematic alcohol intake among Swedish university students.
Methods Students were recruited via e-mails sent to student union members at two universities. Those who gave informed consent, had a smartphone, and showed risky alcohol consumption according to the Alcohol Use Disorders Identification Test (AUDIT) were randomized into three groups. Group 1 had access to the Swedish government alcohol monopoly's app, Promillekoll, offering real-time estimated blood alcohol concentration (eBAC) calculation; Group 2 had access to a web-based app, PartyPlanner, developed by the research group, offering real-time eBAC calculation with planning and follow-up functions; and Group 3 participants were controls. Follow-up was conducted at 7 weeks.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Stockholm, Suecia, 17176
- Karolinska Institutet, department of clinical neuroscience
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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:
- Access to a smartphone running iOS or Android OS.
- AUDIT >7 for men or AUDIT >5 for women.
Exclusion Criteria:
- AUDIT <8 (men) or <6 (women)
- No access to a smartphone running iOS or Android OS.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Control
Grupo de control no tratado
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Experimental: Promillekoll
Smartphone app monitoring alcohol use with feedback.
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Smartphone app monitoring alcohol use with feedback.
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Experimental: PartyPlanner
Smartphone-adapted web based app for simulating an event with alcohol consumption in advance, real time monitoring alcohol use with feedback during the event and the possibility to compare these two.
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Smartphone-adapted web based app for simulating an event with alcohol consumption in advance, real time monitoring alcohol use with feedback during the event and the possibility to compare these two.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in estimated Blood Alcohol Concentration (eBAC)
Periodo de tiempo: 7 weeks
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Change in Blood Alcohol Concentration estimated using Widmark's formula for Blood Alcohol Concentration estimation.
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7 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
AUDIT-C
Periodo de tiempo: 7 weeks
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The change in score for the first three AUDIT questions, as a measure of alcohol consumption only, referred to as the AUDIT-C.
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7 weeks
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Alcohol Use Disorders Identification Test (AUDIT)
Periodo de tiempo: 7 weeks
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Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).
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7 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Anne H Berman, PhD, Karolinska Institutet
Publicaciones y enlaces útiles
Enlaces Útiles
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 (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
- 2012/1126-31/1
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. .
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Ensayos clínicos sobre Promillekoll
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Karolinska InstitutetTerminadoConsumo excesivo de alcohol | Uso problemático de AODSuecia