A Case Management Algorithm for Women Victims of Violence
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More University Hospital, Lille trials in France
Other trials for the same condition
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