NCT06415968

Brief Summary

Intimate violence against individuals, which is particularly marked among women, is one of the most widespread human rights violations in the world. The Women Abuse Screening Tool (WAST) self-questionnaire is a screening tool validated in French. Our preliminary data describing the association between intimate violence against women and the first attack of unexplained venous thromboembolic disease, show a significant frequency of positive responses to the WAST among women attending a biological hematology consultation at the CHU de Nîmes, for reasons of hemostasis disorders (8% out of the first 200 cases). The study authors wish to establish the prevalence of this situation among patients presenting to the CHU de Nîmes for hematological exploration and management. They hypothesize that the prevalence of violence against individuals seen in Hematology consultations is higher among individuals with hemostasis pathologies (hemorrhagic and thrombotic pathologies) than those with cellular pathologies, and higher among women than men.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

May 13, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

September 10, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2025

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

May 13, 2024

Last Update Submit

February 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of patients experiencing Intimate Partner Violence according to consulting department

    Percentage of patients with a Women Abuse Screening Tool (WAST) score ≥ 5 consulting in the hemostasis pathology versus cellular hematological pathology department. The WAST is an 8-item questionnaire with a score ranging from 0 to 16 (worst violence), with a cut-off of 5 for presence of violence

    Day 0

Secondary Outcomes (4)

  • Prevalence of Intimate Partner Violence in men versus women according to consulting department

    Day 0

  • Prevalence of Intimate Partner Violence according to patient disease status and gender

    Day 0

  • WAST questionnaire score according to patient disease status and gender

    Day 0

  • Association between the major risk factors for Intimate Partner Violence and WAST score.

    Day 0

Study Arms (1)

Patients presenting at a biological hematology consultation

Eligibility Criteria

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

Outpatients attending consultations at the CHU de Nîmes for hematological diseases.

You may qualify if:

  • Currently in a relationship or has been in one in the last 12 months, regardless of the length of the relationship
  • Willing to complete the anonymous WAST self-questionnaire
  • able to read and understand French
  • Outpatient consultant at Nîmes University Hospital in one of the following departments:
  • Biological hematology consultation
  • Clinical hematology consultation
  • Vascular medicine consultation

You may not qualify if:

  • Individuals under court protection, guardianship or curatorship
  • Individuals unable to read and understand French
  • Individuals who have already completed the WAST questionnaire during the study period
  • Individuals unable to get away from their partner during the consultation to complete the questionnaire in isolation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nimes

Nîmes, France

Location

MeSH Terms

Conditions

Venous ThrombosisPulmonary EmbolismThrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Study Officials

  • Jean-Christophe Gris

    CHU de Nimes

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 13, 2024

First Posted

May 16, 2024

Study Start

September 10, 2024

Primary Completion

February 11, 2025

Study Completion

February 11, 2025

Last Updated

February 18, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations