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

2022年2月15日 更新者: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.

研究概览

地位

主动,不招人

详细说明

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.

研究类型

观察性的

注册 (实际的)

32

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Bordeaux、法国
        • CH Perrens - Equipe Addiction
      • Bordeaux、法国
        • MéRISP - Université U1219

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Severity of alcohol use
大体时间:12 months after the start of IACA
12 months after the start of IACA

次要结果测量

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Linda Cambon, PhD、Bordeaux University Hospital, Bordeaux University U1219
  • 研究主任:François Alla, MD, PhD、Bordeaux University Hospital, Bordeaux University U1219
  • 研究主任:Marc Auriacombe, MD, PhD、CNRS USR 3413 SANPSY, Bordeaux University, Bordeaux Hospital University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年4月16日

初级完成 (预期的)

2022年4月1日

研究完成 (预期的)

2023年4月1日

研究注册日期

首次提交

2021年6月2日

首先提交符合 QC 标准的

2021年6月8日

首次发布 (实际的)

2021年6月16日

研究记录更新

最后更新发布 (实际的)

2022年2月16日

上次提交的符合 QC 标准的更新

2022年2月15日

最后验证

2022年2月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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