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

Alcoholism Clinical Trial

— VITAE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04927455
• Other study ID #: CHUBX 2020/35
• Status: Active, not recruiting
• Start date: April 16, 2021
• Est. completion date: April 2023

Study information

• Verified date: February 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: April 2023
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Addiction, Alcohol
• Alcoholism
• Behavior, Addictive
• Craving

Locations

Country	Name	City	State
France	CH Perrens - Equipe Addiction	Bordeaux
France	MéRISP - Université U1219	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (2)

Cambon L, Minary L, Ridde V, Alla F. Transferability of interventions in health education: a review. BMC Public Health. 2012 Jul 2;12:497. doi: 10.1186/1471-2458-12-497. Review. — View Citation

Thabane L, Cambon L, Potvin L, Pommier J, Kivits J, Minary L, Nour K, Blaise P, Charlesworth J, Alla F; Discussion Panel. Population health intervention research: what is the place for pilot studies? Trials. 2019 May 30;20(1):309. doi: 10.1186/s13063-019-3422-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of alcohol use		12 months after the start of IACA
Secondary	Utility dimension of viability - alcohol consumption	Average number of units of alcohol consumption in the past 30 days	Baseline (M0)
Secondary	Utility dimension of viability - alcohol consumption	Average number of units of alcohol consumption in the past 30 days	3 months (M3)
Secondary	Utility dimension of viability - alcohol consumption	Average number of units of alcohol consumption in the past 30 days	6 months (M6)
Secondary	Utility dimension of viability - alcohol consumption	Average number of units of alcohol consumption in the past 30 days	9 months (M9)
Secondary	Utility dimension of viability - alcohol consumption	Average number of units of alcohol consumption in the past 30 days	12 months (M12)
Secondary	Utility dimension of viability - craving	Craving: average frequency and intensity in the last 30 days	Baseline (M0)
Secondary	Utility dimension of viability - craving	Craving: average frequency and intensity in the last 30 days	3 months (M3)
Secondary	Utility dimension of viability - craving	Craving: average frequency and intensity in the last 30 days	6 months (M6)
Secondary	Utility dimension of viability - craving	Craving: average frequency and intensity in the last 30 days	9 months (M9)
Secondary	Utility dimension of viability - craving	Craving: average frequency and intensity in the last 30 days	12 months (M12)
Secondary	Utility dimension of viability - severity	Severity score for addictive substances and behaviors	Baseline (M0)
Secondary	Utility dimension of viability - severity	Severity score for addictive substances and behaviors	3 months (M3)
Secondary	Utility dimension of viability - severity	Severity score for addictive substances and behaviors	6 months (M6)
Secondary	Utility dimension of viability - severity	Severity score for addictive substances and behaviors	9 months (M9)
Secondary	Utility dimension of viability - severity	Severity score for addictive substances and behaviors	12 months (M12)
Secondary	Utility dimension of viability - disorders	Presence of alcohol and other substance use disorders (past 12 months and past)	Baseline (M0)
Secondary	Utility dimension of viability - disorders	Presence of alcohol and other substance use disorders (past 12 months and past)	3 months (M3)
Secondary	Utility dimension of viability - disorders	Presence of alcohol and other substance use disorders (past 12 months and past)	6 months (M6)
Secondary	Utility dimension of viability - disorders	Presence of alcohol and other substance use disorders (past 12 months and past)	9 months (M9)
Secondary	Utility dimension of viability - disorders	Presence of alcohol and other substance use disorders (past 12 months and past)	12 months (M12)
Secondary	Utility dimension of viability - Other substances	Number of days of use of other substances/behaviours in the past 30 days	Baseline (M0)
Secondary	Utility dimension of viability - Other substances	Number of days of use of other substances/behaviours in the past 30 days	3 months (M3)
Secondary	Utility dimension of viability - Other substances	Number of days of use of other substances/behaviours in the past 30 days	6 months (M6)
Secondary	Utility dimension of viability - Other substances	Number of days of use of other substances/behaviours in the past 30 days	9 months (M9)
Secondary	Utility dimension of viability - Other substances	Number of days of use of other substances/behaviours in the past 30 days	12 months (M12)
Secondary	Utility dimension of viability - Inventory	Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days	Baseline (M0)
Secondary	Utility dimension of viability - Inventory	Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days	3 months (M3)
Secondary	Utility dimension of viability - Inventory	Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days	6 months (M6)
Secondary	Utility dimension of viability - Inventory	Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days	9 months (M9)
Secondary	Utility dimension of viability - Inventory	Inventory of medical, psychosocial and psycho-educational contacts in the last 30 days	12 months (M12)
Secondary	Utility dimension of viability - QoL	Quality of life	Baseline (M0)
Secondary	Utility dimension of viability - QoL	Quality of life	3 months (M3)
Secondary	Utility dimension of viability - QoL	Quality of life	6 months (M6)
Secondary	Utility dimension of viability - QoL	Quality of life	9 months (M9)
Secondary	Utility dimension of viability - QoL	Quality of life	12 months (M12)
Secondary	Conditions of transferability	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)
Secondary	Viability and implementation	Implementation of IACA! (process, resources, activities) including the respect of IACA! success principles (skills, postures)	6 to 12 months (M6 to M12)
Secondary	Viability and utility	"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)
Secondary	Viability and affordability	Affordability for professionals and beneficiaries (financial, geographical, social and cultural levers and brakes of the intervention)	6 to 12 months (M6 to M12)
Secondary	Viability and evaluability	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)
Secondary	Viability and adaptability	Adaptability of IACA! (integration of the action into the context and the current organisation of the centres)	6 to 12 months (M6 to M12)
Secondary	Viability and acceptability	Acceptability of IACA! by professionals and beneficiaries	6 to 12 months (M6 to M12)
Secondary	Feasibility study capacity	The centres' capacity for inclusion (eligibility, recruitment rate, refusal rate)	12 months (M12)
Secondary	Feasibility study complicance	The compliance rates; understanding, acceptability and feasibility of study questionnaires and data collection tools;	12 months (M12)
Secondary	Feasibility study ressources	The ressources required (time required to complete all study forms, professional/centre capacity, etc.)	12 months (M12)