- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01638338
Risky Drinkers and the Web: a RCT Study in Region Friuli-Venezia Giulia. (EFAR-FVG)
Optimizing and Integrating the Delivery of Primary Care Services for Risky Drinkers in Region Friuli-Venezia Giulia
The project aims to develop a new approach to risky drinkers by providing a facilitated website access and creating a local integrated support network.
In order to do so:
1) A non inferiority-randomised controlled study will be performed to test the hypothesis that: Brief intervention for risky drinkers delivered in primary care through facilitated access to an alcohol reduction website has non inferior outcomes to face to face brief intervention.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Far from being only an Italian problem, harmful alcohol consumption puts a heavy burden on people's health. Risky behaviors and socio-economical conditions are closely linked and, thus, during critical economical periods, such as this, alcohol related problems increase significantly.
Screening and Brief Intervention is a very effective method to screen and counsel risky people at primary care level but, nevertheless, general practitioners and other health care professionals don't utilize it.
This is mainly due to the fact that the National Health Services should include it into financial agreements for reimbursement or adopt other incentives that, in this critic period, are difficult to be taken into consideration.
What are the alternatives? Utilizing existing resources to propose a different approach at little or no cost: the web and the local communities.
Computers are in almost every house and, if not, the local community can offer their use within libraries or social centres.
Computers are definitely utilized by young people and youngsters are the first to suffer from risky alcohol use. Older people are more and more using them maybe just to surf the web but, if not, its use could be facilitated by their general practitioners.
As stated before, no scientific evidence exists on its effectiveness in respect to the GPs work. For this reason we decided to compare the efficacy of a web based "brief intervention" with a face-to-face brief intervention performed by general practitioners.
We would like to see if a web based approach is, at least, as good as, or not inferior to GPs work.
This project could have an important impact at regional and national level. It could be the starting point of a different way to provide alcohol related health services, utilizing up to date working tools, such as smart phones or iPads, giving a different role to the GPs and improving the action of local social services.
The work of general practitioners could also benefit and more integration with the territorial services could bring to increased visibility of Local Authorities.
The supervision of national and international high-level experts will assure an outstanding quality to the project and the possibility of future inclusion of its results within national or international guidelines for primary care alcohol related services.
This study is a part of a wider community program aiming at involving GPs and Local Authorities for its implementation whose objectives are out of the scope of this RCT.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Monfalcone, Italia, 34074
- Regional Centre for the Training in Primary Care
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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:
- All patients scoring above the agreed cut-point (AUDIT-C: 5 for men and 4 for women) will be invited by their GP to use the trial online consent and assessment module
Exclusion Criteria:
- Patients aged less than 18 years and those who do not give consent will be excluded from the trial and encouraged on-line to make an appointment with their doctor to discuss their drinking habits. Those whose scores indicate dependence will also be excluded from the trial and encouraged on-line to seek additional medical support including referral to a specialist agency
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Web site
A specific web site for randomization and risky alcohol consumption counseling will be beta tested and created. Risky drinkers allocated to this arm will receive web assisted brief motivational interview. They will first be assessed towards risky alcohol consumption and Quality of life (AUDIT and EQ5D). Personal health status will also be assessed with a Likert scale. Brief Intervention will be administered following a consistent number of web pages reporting brief motivational interview Web assisted brief motivational interview on risky drinking |
People allocated to this arm will be given a password to enter and follow a pre-decided set of questions and hints to reduce their drinking
Otros nombres:
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Experimental: Face to Face
Risky drinking brief motivational interview provided by the GP.
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The counseling provided by the GPs will be done at month 0, 6, 12
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Alcohol consumption reduction: Full AUDIT (10 questions)
Periodo de tiempo: up to one year
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This measure is referred to the alcohol use reduction
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up to one year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Economic evaluation
Periodo de tiempo: one year
|
The EQ-5D 5L quality-of-life questionnaire, validated Italian version
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one year
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Paul Wallace, prof, Leeds University
- Silla de estudio: Emanuele Scafato, prof, Istituto Superiore di Sanità
Publicaciones y enlaces útiles
Publicaciones Generales
- Hunter R, Wallace P, Struzzo P, Vedova RD, Scafuri F, Tersar C, Lygidakis C, McGregor R, Scafato E, Freemantle N. Randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website: cost-effectiveness analysis. BMJ Open. 2017 Nov 3;7(11):e014577. doi: 10.1136/bmjopen-2016-014577.
- Wallace P, Struzzo P, Della Vedova R, Scafuri F, Tersar C, Lygidakis C, McGregor R, Scafato E, Hunter R, Freemantle N. Randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website. BMJ Open. 2017 Nov 3;7(11):e014576. doi: 10.1136/bmjopen-2016-014576.
- Lygidakis C, Wallace P, Tersar C, Marcatto F, Ferrante D, Della Vedova R, Scafuri F, Scafato E, Struzzo P. Download Your Doctor: Implementation of a Digitally Mediated Personal Physician Presence to Enhance Patient Engagement With a Health-Promoting Internet Application. JMIR Res Protoc. 2016 Mar 4;5(1):e36. doi: 10.2196/resprot.5232.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Otros números de identificación del estudio
- RF-2010-2318620
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