Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID04953273

Effectiveness of a Case Management Algorithm on Clinical Outcome After Consultations Requested in a Clinical Forensic Medicine Unit by Female Victims of Violence

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

756

Participants Needed

8

Research Sites

N/A

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

Women who have experienced interpersonal violence often face a higher risk of developing post-traumatic stress disorder (PTSD). In France, female victims can request a medico-legal examination at a clinical forensic medicine unit, which also offers initial psychological assessment. However, many women do not attend follow-up appointments. This research is a prospective, multicenter, open-label, randomized controlled trial aiming to evaluate the effectiveness of a case management algorithm that uses early phone contact to improve clinical outcomes after such consultations for female victims of violence. Participants are divided into two groups. The experimental group, called VIGITRAUMA, will receive a phone call three weeks after their consultation, with a second call if needed. If contact is not made after the second call, a postcard will be sent. The control group will receive the usual follow-up care without this additional phone contact. The study is conducted by the University Hospital, Lille. Participants will be assessed through phone calls at 3, 6, and 12 months after their consultation to monitor clinical outcomes. Researchers will measure PTSD symptom severity, general psychopathology, somatic symptoms, medical costs, judicial outcomes, suicidal thoughts, and suicide attempts. The study aims to track these outcomes over a full year to understand the impact of the case management algorithm compared to standard care.

CONDITIONS

Brief 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
  • Experience intrafamilial or intimate partner violence
  • Do not speak French

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 3 weeks after initial consultation

Participants receive case management support including phone contact at 3 weeks after consultation, with a second phone call if necessary, and a postcard if contact is not established.

1 to 2 phone contacts and 1 postcard if needed

Follow-up

Duration - 12 months

Participants are followed to assess clinical outcomes, symptom severity, medical costs, judicial outcomes, and suicidal ideation over 12 months.

Assessments at 3, 6, and 12 months

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

A

Anne-Laure Demarty

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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