NCT05173116

Brief Summary

The study was designed to evaluate the APIVIGIE program use at CH d'Arras. The objective of this program is to reduce repeated visits by the same patient to the emergency room for Alcoholism Severe Paroxysmal

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

November 29, 2021

Last Update Submit

January 9, 2023

Conditions

Keywords

Intoxication;Alcohol;AcuteAddiction, Alcoholbinge drinkingyoung adult

Outcome Measures

Primary Outcomes (1)

  • Number of visits to the Emergency Reception Service for Significant Paroxysmal Alcoholics

    1 year before implementation of the program and up to 1 year after implementation of the program

    during 2 years

Secondary Outcomes (3)

  • weekly consumption of alcoholic beverages

    Inclusion , Visit 2 (Month 3) and visit 3 (Month 6)

  • weekly consumption of other substances (cannabis, other substances)

    Inclusion , Visit 2 (Month 3) and visit 3 (Month 6)

  • Quality of life score, measured by the Medical Outcomes Study Short Form 36 (SF-36) health scale score.

    Inclusion , Visit 2 (Month 3) and visit 3 (Month 6)

Study Arms (2)

prospective study

API-VIGIE program adult participant who agreed to participate in the study

Other: Medical Outcomes Study Short Form 36 (SF 36)

retrospective study

Any stay for adults patients in the emergency room of the ARRAS hospital for API during the period covered (from 1 year before to 1 year after the installation of the APIVIGIE program) (main diagnosis or associated with an API (F10.0 according to the ICD-10 classification used by Department of Medical Information)

Other: observationnal study

Interventions

completion of questionnaire quality of life SF 36 (inclusion, Month 3, Month 6).

prospective study

data collection

retrospective study

Eligibility Criteria

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

Participant at API-VIGIE program

You may qualify if:

  • Patient 18 years or older;
  • Participant at API-VIGIE program.

You may not qualify if:

  • Patient's opposition to participating in the research;
  • Persons under legal protection (under tutorship or curatorship);
  • Person deprived of liberty;
  • Pregnant or breastfeeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dominique LEJEUNE

Arras, France

Location

MeSH Terms

Conditions

Alcoholic IntoxicationEmergenciesAlcoholismBinge Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAlcohol DrinkingDrinking BehaviorBehavior

Study Officials

  • Dominique LEJEUNE, M.D

    Centre Hospitalier Arras

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 29, 2021

Study Start

February 1, 2022

Primary Completion

February 1, 2023

Study Completion

August 1, 2023

Last Updated

January 11, 2023

Record last verified: 2023-01

Locations