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Pilot Study to Evaluate "Intégrer et Accompagner Les Consommations d'Alcool!" (IACA!)'s Impact and Transferability (VITAE)

15 de febrero de 2022 actualizado por: University Hospital, Bordeaux

Pilot Study to Evaluate Impact and Transferability of an Alcohol Focused Harm Reduction Support System Based on Mental Health Recovery Named IACA!

In France, alcohol consumption is the second most common cause of so-called preventable cancers after tobacco. Since 2014, in the "Provence-Alpes-Côte d'Azur" (PACA) region, the association Santé! has been developing an innovative intervention to support people suffering from alcohol-related addiction. This intervention, called IACA! must therefore be evaluated on a larger scale before conclusions about its effectiveness can be drawn from a comparative trial.

This evaluation requires significant human and material resources. It is therefore recommended to first assess the transferability of IACA! in other care centers in a pilot study.

Descripción general del estudio

Estado

Activo, no reclutando

Descripción detallada

In France, 11% of cancers in men and 4.5% of cancers in women are attributed to alcohol consumption. It is the second leading cause of so-called preventable cancers, accounting for 28,000 alcohol-related cancers out of 352,000 new cases of cancer affecting annually adults (over 30 years of age). Overall, alcohol is among the top 3 factors contributing to Disability-Adjusted life year (DALYs) in France in 2017. Some cancer risks can be quantified as early as one drink a day (oesophagus, oral cavity, pharynx and breast in women). However, the risks associated with alcohol consumption remain influenced by the quantities consumed. There is therefore an interest, particularly for consumers of the largest quantities, in reducing the quantities consumed. In Europe, while people who drink more than 60 g/d of alcohol for men and 40 g/d for women are estimated to represent only 16.1% of the population for men and 9.3% for women, they represent 87% and 82% of alcohol-related morbidity and mortality respectively. Subjects with addiction (or substance use disorders) have an increased risk of social harm (1.5 to 3 times that of alcohol users without addiction), a higher mortality (1.4 to 6.5 compared to the general population) with a life expectancy of 9 to 20 years shorter than that of the general population. Moreover, even if the quantities consumed are not a valid individual diagnostic criterion, studies show a strong association between the quantity consumed and the diagnosis of addiction. Finally, some studies suggest that the prevalence of secondary harm from alcohol use follows an exponential curve as a function of alcohol consumption.

Since 2014, in the PACA region, the association Santé! has been developing an intervention to support people suffering from alcohol-related addiction. This intervention, called IACA! (Integrating and supporting alcohol consumption), differs from the support provided during rehabilitation cures and aims to: fight against discrimination and exclusion of people who drink alcohol, re-engage these individuals in the care process (because they have generally left it) by using the appropriate levers, promote well-being, improve quality of life and recovery and support the recovery in control of consumption. Thus, IACA!, through its philosophy and implementation, is based both on the risk reduction approach historically deployed with drug users and on the recovery approach, developed in the field of mental health. The first one-year results of this program were promising since, of 17 people who received the intervention, all had a social or health benefit, 13 of whom were associated with stabilization (n=4), reduction (n=7) or cessation (n=2) of alcohol use.

These promising results must therefore be evaluated on a larger scale before conclusions about its effectiveness can be drawn from a comparative trial. This type of evaluation requires significant human and material resources. It is therefore recommended to first assess in the field: 1) the conditions under which such an intervention is deployed in other centres (adaptations implemented by other centres to deploy IACA! for example, without distorting the intervention), 2) the acceptability and feasibility of the intervention in other centres (are the human and material resources on site sufficient for the successful deployment of the intervention?), 3) the acceptability and feasibility of the large-scale evaluation envisaged.

Tipo de estudio

De observación

Inscripción (Actual)

32

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

      • Bordeaux, Francia
        • CH Perrens - Equipe Addiction
      • Bordeaux, Francia
        • MéRISP - Université U1219

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

This research will investigate three types of populations:

  • Individuals receiving support from the IACA! Intervention (called beneficiaries),
  • Professionals implementing the IACA! Intervention i.e. the pairs in charge of accompanying the beneficiaries in the centers as well as the persons in charge of these centers,
  • Professionals from Santé! supporting the deployment of the IACA! intervention.

The beneficiaries are all persons integrating the program in the project's partner sites and consuming alcohol.

The professionals will be specialized educators, social workers, nurses, social and solidarity economy advisors, etc.

Descripción

Inclusion criteria common to the 3 populations:

  • Over 18 years of age
  • whatever the gender
  • Non-opposition to participate

Inclusion criteria for professionals from centers implementing IACA! :

Concerning professionals in contact with the patients:

  • Having been trained at IACA!
  • Working in the centers participating in the implementation of IACA!

Concerning the persons in charge of the centers :

These professionals are those who have participated in the deployment of the IACA! method in their centers

Criteria for the inclusion of health professionals ! Participating or having recently participated in the implementation of IACA!

Exclusion Criteria:

The beneficiaries will be excluded if they have a severe somatic or psychiatric pathology that is incompatible with understanding the assessment tools; difficulty understanding and/or writing French; if they are unreachable by telephone, if they are participating in another research project with an ongoing exclusion period, if they are placed under court protection and if they are pregnant.

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Severity of alcohol use
Periodo de tiempo: 12 months after the start of IACA
12 months after the start of IACA

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Utility dimension of viability - alcohol consumption
Periodo de tiempo: Baseline (M0)
Average number of units of alcohol consumption in the past 30 days
Baseline (M0)
Utility dimension of viability - alcohol consumption
Periodo de tiempo: 3 months (M3)
Average number of units of alcohol consumption in the past 30 days
3 months (M3)
Utility dimension of viability - alcohol consumption
Periodo de tiempo: 6 months (M6)
Average number of units of alcohol consumption in the past 30 days
6 months (M6)
Utility dimension of viability - alcohol consumption
Periodo de tiempo: 9 months (M9)
Average number of units of alcohol consumption in the past 30 days
9 months (M9)
Utility dimension of viability - alcohol consumption
Periodo de tiempo: 12 months (M12)
Average number of units of alcohol consumption in the past 30 days
12 months (M12)
Utility dimension of viability - craving
Periodo de tiempo: Baseline (M0)
Craving: average frequency and intensity in the last 30 days
Baseline (M0)
Utility dimension of viability - craving
Periodo de tiempo: 3 months (M3)
Craving: average frequency and intensity in the last 30 days
3 months (M3)
Utility dimension of viability - craving
Periodo de tiempo: 6 months (M6)
Craving: average frequency and intensity in the last 30 days
6 months (M6)
Utility dimension of viability - craving
Periodo de tiempo: 9 months (M9)
Craving: average frequency and intensity in the last 30 days
9 months (M9)
Utility dimension of viability - craving
Periodo de tiempo: 12 months (M12)
Craving: average frequency and intensity in the last 30 days
12 months (M12)
Utility dimension of viability - severity
Periodo de tiempo: Baseline (M0)
Severity score for addictive substances and behaviors
Baseline (M0)
Utility dimension of viability - severity
Periodo de tiempo: 3 months (M3)
Severity score for addictive substances and behaviors
3 months (M3)
Utility dimension of viability - severity
Periodo de tiempo: 6 months (M6)
Severity score for addictive substances and behaviors
6 months (M6)
Utility dimension of viability - severity
Periodo de tiempo: 9 months (M9)
Severity score for addictive substances and behaviors
9 months (M9)
Utility dimension of viability - severity
Periodo de tiempo: 12 months (M12)
Severity score for addictive substances and behaviors
12 months (M12)
Utility dimension of viability - disorders
Periodo de tiempo: Baseline (M0)
Presence of alcohol and other substance use disorders (past 12 months and past)
Baseline (M0)
Utility dimension of viability - disorders
Periodo de tiempo: 3 months (M3)
Presence of alcohol and other substance use disorders (past 12 months and past)
3 months (M3)
Utility dimension of viability - disorders
Periodo de tiempo: 6 months (M6)
Presence of alcohol and other substance use disorders (past 12 months and past)
6 months (M6)
Utility dimension of viability - disorders
Periodo de tiempo: 9 months (M9)
Presence of alcohol and other substance use disorders (past 12 months and past)
9 months (M9)
Utility dimension of viability - disorders
Periodo de tiempo: 12 months (M12)
Presence of alcohol and other substance use disorders (past 12 months and past)
12 months (M12)
Utility dimension of viability - Other substances
Periodo de tiempo: Baseline (M0)
Number of days of use of other substances/behaviours in the past 30 days
Baseline (M0)
Utility dimension of viability - Other substances
Periodo de tiempo: 3 months (M3)
Number of days of use of other substances/behaviours in the past 30 days
3 months (M3)
Utility dimension of viability - Other substances
Periodo de tiempo: 6 months (M6)
Number of days of use of other substances/behaviours in the past 30 days
6 months (M6)
Utility dimension of viability - Other substances
Periodo de tiempo: 9 months (M9)
Number of days of use of other substances/behaviours in the past 30 days
9 months (M9)
Utility dimension of viability - Other substances
Periodo de tiempo: 12 months (M12)
Number of days of use of other substances/behaviours in the past 30 days
12 months (M12)
Utility dimension of viability - Inventory
Periodo de tiempo: Baseline (M0)
Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days
Baseline (M0)
Utility dimension of viability - Inventory
Periodo de tiempo: 3 months (M3)
Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days
3 months (M3)
Utility dimension of viability - Inventory
Periodo de tiempo: 6 months (M6)
Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days
6 months (M6)
Utility dimension of viability - Inventory
Periodo de tiempo: 9 months (M9)
Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days
9 months (M9)
Utility dimension of viability - Inventory
Periodo de tiempo: 12 months (M12)
Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days
12 months (M12)
Utility dimension of viability - QoL
Periodo de tiempo: Baseline (M0)
Quality of life
Baseline (M0)
Utility dimension of viability - QoL
Periodo de tiempo: 3 months (M3)
Quality of life
3 months (M3)
Utility dimension of viability - QoL
Periodo de tiempo: 6 months (M6)
Quality of life
6 months (M6)
Utility dimension of viability - QoL
Periodo de tiempo: 9 months (M9)
Quality of life
9 months (M9)
Utility dimension of viability - QoL
Periodo de tiempo: 12 months (M12)
Quality of life
12 months (M12)
Conditions of transferability
Periodo de tiempo: 9 to 12 months (M9 to M12)
Conditions of transferability linked to the characteristics of the stakeholders and the context: contextual conditions for success within the centres, the characteristics of professionals and patients influencing outcomes
9 to 12 months (M9 to M12)
Viability and implementation
Periodo de tiempo: 6 to 12 months (M6 to M12)
Implementation of IACA! (process, resources, activities) including the respect of IACA! success principles (skills, postures)
6 to 12 months (M6 to M12)
Viability and utility
Periodo de tiempo: 6 to 12 months (M6 to M12)
"utility" dimension (as a complement to the secondary criteria) of viability through the recovery mechanisms identified as successful mental health recovery
6 to 12 months (M6 to M12)
Viability and affordability
Periodo de tiempo: 6 to 12 months (M6 to M12)
Affordability for professionals and beneficiaries (financial, geographical, social and cultural levers and brakes of the intervention)
6 to 12 months (M6 to M12)
Viability and evaluability
Periodo de tiempo: 6 to 12 months (M6 to M12)
Evaluability of IACA: carrying out this evaluation, the availability of professionals and beneficiaries to answer questionnaires and interviews, missing data in the questionnaires etc.
6 to 12 months (M6 to M12)
Viability and adaptability
Periodo de tiempo: 6 to 12 months (M6 to M12)
Adaptability of IACA! (integration of the action into the context and the current organisation of the centres)
6 to 12 months (M6 to M12)
Viability and acceptability
Periodo de tiempo: 6 to 12 months (M6 to M12)
Acceptability of IACA! by professionals and beneficiaries
6 to 12 months (M6 to M12)
Feasibility study capacity
Periodo de tiempo: 12 months (M12)
The centres' capacity for inclusion (eligibility, recruitment rate, refusal rate)
12 months (M12)
Feasibility study complicance
Periodo de tiempo: 12 months (M12)
The compliance rates; understanding, acceptability and feasibility of study questionnaires and data collection tools;
12 months (M12)
Feasibility study ressources
Periodo de tiempo: 12 months (M12)
The ressources required (time required to complete all study forms, professional/centre capacity, etc.)
12 months (M12)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Silla de estudio: Linda Cambon, PhD, Bordeaux University Hospital, Bordeaux University U1219
  • Director de estudio: François Alla, MD, PhD, Bordeaux University Hospital, Bordeaux University U1219
  • Director de estudio: Marc Auriacombe, MD, PhD, CNRS USR 3413 SANPSY, Bordeaux University, Bordeaux Hospital University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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 (Actual)

16 de abril de 2021

Finalización primaria (Anticipado)

1 de abril de 2022

Finalización del estudio (Anticipado)

1 de abril de 2023

Fechas de registro del estudio

Enviado por primera vez

2 de junio de 2021

Primero enviado que cumplió con los criterios de control de calidad

8 de junio de 2021

Publicado por primera vez (Actual)

16 de junio de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de febrero de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

15 de febrero de 2022

Última verificación

1 de febrero de 2022

Más información

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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