Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT04953273

A Case Management Algorithm for Women Victims of Violence

Led by University Hospital, Lille · Updated on 2026-05-14

756

Participants Needed

8

Research Sites

260 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Lille

Lead Sponsor

M

Ministry of Health, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

A considerable body of research has demonstrated that women who are victims of interpersonal violence are at substantially elevated risk for the development of post-traumatic stress disorder (PTSD). In France, victims can request a medico-legal examination in a clinical forensic medicine unit. Although these units are also a place for initial psychological examination, women often don't attend future scheduled appointments. Decision-making algorithm using phone contact are effective in suicide prevention. Our aim is to assess the effectiveness of case management algorithm using early phone contact compared to a control group treated as usual on clinical outcome after consultation requested in a clinical forensic medicine unit by female victims of violence. Method: Prospective, multicenter, open-label, randomized controlled clinical trial, for women victims of violence. Victims randomized in VIGITRAUMA group will be contacted by phone at 3 weeks after the consultation in a clinical forensic medicine unit, and a second phone call can be done. If the subject is not contacted after the second phone call, he will receive a postcard. Control group will benefit from usual follow-up. All the subjects included will be then evaluated at 3 months, 6 months and 1 year during a phone call.

CONDITIONS

Official Title

A Case Management Algorithm for Women Victims of Violence

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women
  • 18 years and older
  • Consultation requested in a clinical forensic medicine unit after being victim of violence
  • Exposure to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence (PTSD criterion A - DSM-5)
  • Have social insurance
  • Consent to participate in the study
Not Eligible

You will not qualify if you...

  • Do not consent to participate in the study
  • Victims of intrafamilial or intimate partner violence
  • Do not speak French

AI-Screening

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Trial Site Locations

Total: 8 locations

1

University Hospital, Amiens

Amiens, France

Not Yet Recruiting

2

General Hospital, Boulogne sur Mer

Boulogne-sur-Mer, France

Not Yet Recruiting

3

University Hospital, Caen

Caen, France

Not Yet Recruiting

4

General Hospital, Creil

Creil, France

Not Yet Recruiting

5

University Hospital, Lille

Lille, France

Actively Recruiting

6

University Hospital, Rouen

Rouen, France

Not Yet Recruiting

7

General Hospital, Saint-Quentin

Saint-Quentin, France

Not Yet Recruiting

8

General Hospital, Valenciennes

Valenciennes, France

Not Yet Recruiting

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Research Team

A

Arnaud Leroy, MD

CONTACT

A

Anne-Laure Demarty

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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