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

U

University Hospital, Lille

Status

Enrolling

Conditions

Post-Traumatic Stress Disorder
Violence-Related Symptom

Treatments

Other: Vigitrauma

Study type

Interventional

Funder types

Other

Identifiers

NCT04953273
2020-A02591-38 (Other Identifier)
2020_ 01

Details and patient eligibility

About

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.

Enrollment

756 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

756 participants in 2 patient groups

Vigitrauma
Experimental group
Description:
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.
Treatment:
Other: Vigitrauma
Control group
No Intervention group
Description:
Usual follow-up.

Trial contacts and locations

0

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Central trial contact

Anne-Laure Demarty; Arnaud Leroy, MD

Data sourced from clinicaltrials.gov

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