NCT04927455

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

12 months

First QC Date

June 2, 2021

Last Update Submit

February 15, 2022

Conditions

Keywords

Public Health; Alcohol use and addiction; risk reduction; innovation; mental health recovering; Transferability; Viability; Pilot study

Outcome Measures

Primary Outcomes (1)

  • Severity of alcohol use

    12 months after the start of IACA

Secondary Outcomes (45)

  • Utility dimension of viability - alcohol consumption

    Baseline (M0)

  • Utility dimension of viability - alcohol consumption

    3 months (M3)

  • Utility dimension of viability - alcohol consumption

    6 months (M6)

  • Utility dimension of viability - alcohol consumption

    9 months (M9)

  • Utility dimension of viability - alcohol consumption

    12 months (M12)

  • +40 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CH Perrens - Equipe Addiction

Bordeaux, France

Location

MéRISP - Université U1219

Bordeaux, France

Location

Related Publications (3)

  • 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.

    PMID: 31146768BACKGROUND
  • 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.

    PMID: 22747988BACKGROUND
  • Martin-Fernandez J, Stevens N, Moriceau S, Serre F, Blanc H, Latourte E, Auriacombe M, Cambon L. Realist evaluation of the impact, viability and transferability of an alcohol harm reduction support programme based on mental health recovery: the Vitae study protocol. BMJ Open. 2022 Aug 11;12(8):e065361. doi: 10.1136/bmjopen-2022-065361.

MeSH Terms

Conditions

AlcoholismAlcohol DrinkingBehavior, AddictiveRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehaviorCompulsive BehaviorImpulsive Behavior

Study Officials

  • Linda Cambon, PhD

    Bordeaux University Hospital, Bordeaux University U1219

    STUDY CHAIR
  • François Alla, MD, PhD

    Bordeaux University Hospital, Bordeaux University U1219

    STUDY DIRECTOR
  • Marc Auriacombe, MD, PhD

    CNRS USR 3413 SANPSY, Bordeaux University, Bordeaux Hospital University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 16, 2021

Study Start

April 16, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2023

Last Updated

February 16, 2022

Record last verified: 2022-02

Locations