Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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