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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
University Hospital, Amiens
NOT_YET_RECRUITING
Amiens
General Hospital, Boulogne sur Mer
NOT_YET_RECRUITING
Boulogne-sur-mer
University Hospital, Caen
NOT_YET_RECRUITING
Caen
General Hospital, Creil
NOT_YET_RECRUITING
Creil
University Hospital, Lille
RECRUITING
Lille
University Hospital, Rouen
NOT_YET_RECRUITING
Rouen
General Hospital, Saint-Quentin
NOT_YET_RECRUITING
Saint-quentin
General Hospital, Valenciennes
NOT_YET_RECRUITING
Valenciennes
Contact Information
Primary
Arnaud Leroy, MD
arnaud.leroy@chru-lille.fr
+33 320444460
Backup
Anne-Laure Demarty
anne-laure.demarty@chru-lille.fr
+33 320444145
Time Frame
Start Date: 2021-07-06
Estimated Completion Date: 2026-07
Participants
Target number of participants: 756
Treatments
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.
No_intervention: Control group
Usual follow-up.
Related Therapeutic Areas
Sponsors
Collaborators: Ministry of Health, France
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov