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Recruiting Not applicable

A Case Management Algorithm for Women Victims of Violence

NCT04953273 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-07-06
Last updated
2026-05-14

Condition(s) studied

Post-Traumatic Stress DisorderViolence-Related Symptom

Investigational drug(s) / intervention(s)

Vigitrauma

Vigitrauma: Case management algorithm using early phone contact

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Clinical Outcome — 3 months
    Rate of patients with a Clinical Global Impression (CGI) severity scale \< 4
  • Clinical Outcome — 6 months
    Rate of patients with a Clinical Global Impression (CGI) severity scale \< 4
  • Clinical Outcome — 12 months
    Rate of patients with a Clinical Global Impression (CGI) severity scale \< 4

Trial sites (8)

FacilityCityRegionStatus
University Hospital, Amiens Amiens France Not Yet Recruiting
General Hospital, Boulogne sur Mer Boulogne-sur-Mer France Not Yet Recruiting
University Hospital, Caen Caen France Not Yet Recruiting
General Hospital, Creil Creil France Not Yet Recruiting
University Hospital, Lille Lille France Recruiting
University Hospital, Rouen Rouen France Not Yet Recruiting
General Hospital, Saint-Quentin Saint-Quentin France Not Yet Recruiting
General Hospital, Valenciennes Valenciennes France Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04953273 on ClinicalTrials.gov ↗ ← All trials in France