A Case Management Algorithm for Women Victims of Violence (VIGITRAUMA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-Traumatic Stress Disorder; Violence-Related Symptom
• Intervention / Treatment: Other: Vigitrauma

• Study Type: Interventional
• Enrollment (Estimated): 756
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arnaud Leroy, MD; Phone Number: +33 320444460; Email: arnaud.leroy@chru-lille.fr
• Study Contact Backup: Name: Anne-Laure Demarty; Phone Number: +33 320444145; Email: anne-laure.demarty@chru-lille.fr

Study Locations

• France
  • Amiens, France
    • Not yet recruiting
    • University Hospital, Amiens
    • Principal Investigator: Cécile MANAOUIL
    • Sub-Investigator: Gaetan PRISSETTE
  • Boulogne-sur-Mer, France
    • Not yet recruiting
    • General Hospital, Boulogne sur Mer
    • Principal Investigator: Stéphane CHOCHOIS
  • Caen, France
    • Not yet recruiting
    • University Hospital, Caen
    • Principal Investigator: Grégoire MOUTEL
  • Creil, France
    • Not yet recruiting
    • General Hospital, Creil
    • Principal Investigator: Georges PATRU
    • Sub-Investigator: Marie-Laure CLINET
  • Lille, France
    • Recruiting
    • University Hospital, Lille
    • Principal Investigator: Yann DELANNOY
  • Rouen, France
    • Not yet recruiting
    • University Hospital, Rouen
    • Principal Investigator: Gilles TOURNEL
  • Saint-Quentin, France
    • Not yet recruiting
    • General Hospital, Saint-Quentin
    • Principal Investigator: Fabien DELFORGE
  • Valenciennes, France
    • Not yet recruiting
    • General Hospital, Valenciennes
    • Principal Investigator: Eric LAURIER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women
• 18 years and older
• Consultation requested in a clinical forensic medicine unit after being victim of violence
• The person was exposed to: death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence (PTSD criterion A - DSM -5)
• With social insurance
• Consent to participate to the study

Exclusion Criteria:

• Do no consent to participate to the study
• Intrafamilial or intimate partner violence
• Do not speak french

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vigitrauma; Contact by phone at 3 weeks after the consultation in a clinical forensic medicine unit, and a second phone call if necessary. If the subject is not contacted after the second phone call, he will receive a postcard.	Other: Vigitrauma; Case management algorithm using early phone contact
No Intervention: Control group; Usual follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcome	Rate of patients with a Clinical Global Impression (CGI) severity scale < 4	3 months
Clinical Outcome	Rate of patients with a Clinical Global Impression (CGI) severity scale < 4	6 months
Clinical Outcome	Rate of patients with a Clinical Global Impression (CGI) severity scale < 4	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of post-traumatic stress disorder symptoms	Post-traumatic stress disorder Checklist Scale-5	3 months, 6 months and 12 months
General psychopathology	French version of Mini International Neuropsychiatric Interview (DSM 5)	3 months, 6 months and 12 months
Severity of somatic symptoms	Physical Health Questionnaire (PHQ-15)	3 months, 6 months and 12 months
Medical cost	Nnumber of hospitalizations, consultations, and drugs consummation	12 months
Judicial outcome	Number of days of temporary inability to work	12 months
Suicidal ideation intensity	The Beck Scale for Suicide Ideation (SSI) The Scale for Suicide Ideation (SSI; Beck, et al., 1979) is a brief 21-item scale that assesses the person's current intensity of attitudes, plans, and behaviors to commit suicide.	12 months
Number of suicide attempters	Suicide risk	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Arnaud Leroy, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Post-Traumatic Stress Disorder; Physical Abuse; Women Health; Forensic Medicine; Case-Management Algorithm
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2020_ 01; 2020-A02591-38 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No