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

15. února 2022 aktualizováno: 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.

Přehled studie

Postavení

Aktivní, ne nábor

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

32

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
Severity of alcohol use
Časové okno: 12 months after the start of IACA
12 months after the start of IACA

Sekundární výstupní opatření

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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Studijní židle: Linda Cambon, PhD, Bordeaux University Hospital, Bordeaux University U1219
  • Ředitel studie: François Alla, MD, PhD, Bordeaux University Hospital, Bordeaux University U1219
  • Ředitel studie: Marc Auriacombe, MD, PhD, CNRS USR 3413 SANPSY, Bordeaux University, Bordeaux Hospital University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

16. dubna 2021

Primární dokončení (Očekávaný)

1. dubna 2022

Dokončení studie (Očekávaný)

1. dubna 2023

Termíny zápisu do studia

První předloženo

2. června 2021

První předloženo, které splnilo kritéria kontroly kvality

8. června 2021

První zveřejněno (Aktuální)

16. června 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

16. února 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. února 2022

Naposledy ověřeno

1. února 2022

Více informací

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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