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

15 de fevereiro de 2022 atualizado 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.

Visão geral do estudo

Status

Ativo, não recrutando

Descrição detalhada

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 estudo

Observacional

Inscrição (Real)

32

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Utility dimension of viability - alcohol consumption
Prazo: Baseline (M0)
Average number of units of alcohol consumption in the past 30 days
Baseline (M0)
Utility dimension of viability - alcohol consumption
Prazo: 3 months (M3)
Average number of units of alcohol consumption in the past 30 days
3 months (M3)
Utility dimension of viability - alcohol consumption
Prazo: 6 months (M6)
Average number of units of alcohol consumption in the past 30 days
6 months (M6)
Utility dimension of viability - alcohol consumption
Prazo: 9 months (M9)
Average number of units of alcohol consumption in the past 30 days
9 months (M9)
Utility dimension of viability - alcohol consumption
Prazo: 12 months (M12)
Average number of units of alcohol consumption in the past 30 days
12 months (M12)
Utility dimension of viability - craving
Prazo: Baseline (M0)
Craving: average frequency and intensity in the last 30 days
Baseline (M0)
Utility dimension of viability - craving
Prazo: 3 months (M3)
Craving: average frequency and intensity in the last 30 days
3 months (M3)
Utility dimension of viability - craving
Prazo: 6 months (M6)
Craving: average frequency and intensity in the last 30 days
6 months (M6)
Utility dimension of viability - craving
Prazo: 9 months (M9)
Craving: average frequency and intensity in the last 30 days
9 months (M9)
Utility dimension of viability - craving
Prazo: 12 months (M12)
Craving: average frequency and intensity in the last 30 days
12 months (M12)
Utility dimension of viability - severity
Prazo: Baseline (M0)
Severity score for addictive substances and behaviors
Baseline (M0)
Utility dimension of viability - severity
Prazo: 3 months (M3)
Severity score for addictive substances and behaviors
3 months (M3)
Utility dimension of viability - severity
Prazo: 6 months (M6)
Severity score for addictive substances and behaviors
6 months (M6)
Utility dimension of viability - severity
Prazo: 9 months (M9)
Severity score for addictive substances and behaviors
9 months (M9)
Utility dimension of viability - severity
Prazo: 12 months (M12)
Severity score for addictive substances and behaviors
12 months (M12)
Utility dimension of viability - disorders
Prazo: Baseline (M0)
Presence of alcohol and other substance use disorders (past 12 months and past)
Baseline (M0)
Utility dimension of viability - disorders
Prazo: 3 months (M3)
Presence of alcohol and other substance use disorders (past 12 months and past)
3 months (M3)
Utility dimension of viability - disorders
Prazo: 6 months (M6)
Presence of alcohol and other substance use disorders (past 12 months and past)
6 months (M6)
Utility dimension of viability - disorders
Prazo: 9 months (M9)
Presence of alcohol and other substance use disorders (past 12 months and past)
9 months (M9)
Utility dimension of viability - disorders
Prazo: 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
Prazo: Baseline (M0)
Number of days of use of other substances/behaviours in the past 30 days
Baseline (M0)
Utility dimension of viability - Other substances
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline (M0)
Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days
Baseline (M0)
Utility dimension of viability - Inventory
Prazo: 3 months (M3)
Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days
3 months (M3)
Utility dimension of viability - Inventory
Prazo: 6 months (M6)
Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days
6 months (M6)
Utility dimension of viability - Inventory
Prazo: 9 months (M9)
Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days
9 months (M9)
Utility dimension of viability - Inventory
Prazo: 12 months (M12)
Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days
12 months (M12)
Utility dimension of viability - QoL
Prazo: Baseline (M0)
Quality of life
Baseline (M0)
Utility dimension of viability - QoL
Prazo: 3 months (M3)
Quality of life
3 months (M3)
Utility dimension of viability - QoL
Prazo: 6 months (M6)
Quality of life
6 months (M6)
Utility dimension of viability - QoL
Prazo: 9 months (M9)
Quality of life
9 months (M9)
Utility dimension of viability - QoL
Prazo: 12 months (M12)
Quality of life
12 months (M12)
Conditions of transferability
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 6 to 12 months (M6 to M12)
Acceptability of IACA! by professionals and beneficiaries
6 to 12 months (M6 to M12)
Feasibility study capacity
Prazo: 12 months (M12)
The centres' capacity for inclusion (eligibility, recruitment rate, refusal rate)
12 months (M12)
Feasibility study complicance
Prazo: 12 months (M12)
The compliance rates; understanding, acceptability and feasibility of study questionnaires and data collection tools;
12 months (M12)
Feasibility study ressources
Prazo: 12 months (M12)
The ressources required (time required to complete all study forms, professional/centre capacity, etc.)
12 months (M12)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Cadeira de estudo: Linda Cambon, PhD, Bordeaux University Hospital, Bordeaux University U1219
  • Diretor de estudo: François Alla, MD, PhD, Bordeaux University Hospital, Bordeaux University U1219
  • Diretor de estudo: Marc Auriacombe, MD, PhD, CNRS USR 3413 SANPSY, Bordeaux University, Bordeaux Hospital University

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

16 de abril de 2021

Conclusão Primária (Antecipado)

1 de abril de 2022

Conclusão do estudo (Antecipado)

1 de abril de 2023

Datas de inscrição no estudo

Enviado pela primeira vez

2 de junho de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de junho de 2021

Primeira postagem (Real)

16 de junho de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de fevereiro de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de fevereiro de 2022

Última verificação

1 de fevereiro de 2022

Mais Informações

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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