NCT04647565

Brief Summary

The alcohol consumption of adults has been decreasing in France since the sixties. When focusing on the particular case of women, this trend goes on the opposite direction. In addition, the impact of drinking alcohol involves an increased severity in women in comparison to men. Furthermore, women consult less often doctors about their alcohol problem due to stigmatisation. Finally, as alcohol consumption is a major public health issue (second preventable cause of death), the aim of this study is to propose an earlier screening of women with alcohol use disorders (AUD) in general medicine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 25, 2021

Status Verified

October 1, 2021

Enrollment Period

7 months

First QC Date

November 23, 2020

Last Update Submit

October 22, 2021

Conditions

Keywords

women reporting alcohol abuse and/or dependencewomen recruted during hospitalisation and/or consultationAlcohol

Outcome Measures

Primary Outcomes (2)

  • Assessment of women's opinion on an alcoholism screening by general practitioners.

    Assessment of women's opinion on an alcoholism screening by general practitioners : Qualitative study based on semi-structured interview with women with AUD.

    1 year

  • Creation of a screening tool dedicated to general practitioners

    Creation of a screening tool dedicated to general practitioners : Built of a screening tool based both on litterature review about alcohol \& women and a qualitative study on women's opinion.

    1 year

Interventions

interviews (human and social sciences)

Eligibility Criteria

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

Over 18 years old alcoholic womens, medical caring in consultation with addictologist or in hospitalisation for withdrawal.

You may qualify if:

  • \- over 18 years old alcoholic women, with one or several addiction, from all social class.

You may not qualify if:

  • \- not being able to answer the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Claire MONTADE

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 23, 2020

First Posted

December 1, 2020

Study Start

December 1, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

October 25, 2021

Record last verified: 2021-10

Locations