Vigitrauma
OtherCase management algorithm using early phone contact
NCT Number: NCT04953273
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
University Hospital, Amiens, Amiens, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Case management algorithm using early phone contact
Time frame: 3 months
Rate of patients with a Clinical Global Impression (CGI) severity scale < 4
Time frame: 6 months
Rate of patients with a Clinical Global Impression (CGI) severity scale < 4
Time frame: 12 months
Rate of patients with a Clinical Global Impression (CGI) severity scale < 4
Time frame: 3 months, 6 months and 12 months
Post-traumatic stress disorder Checklist Scale-5
Time frame: 3 months, 6 months and 12 months
French version of Mini International Neuropsychiatric Interview (DSM 5)
Time frame: 3 months, 6 months and 12 months
Physical Health Questionnaire (PHQ-15)
Time frame: 12 months
Nnumber of hospitalizations, consultations, and drugs consummation
Time frame: 12 months
Number of days of temporary inability to work
Time frame: 12 months
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.
Time frame: 12 months
Suicide risk
Contact information is provided by the study sponsor or research team.
Anne-Laure Demarty
CONTACT
Arnaud Leroy, MD
CONTACT
University Hospital, Lille
Other
Effectiveness of a Case Management Algorithm on Clinical Outcome After Consultations Requested in a Clinical Forensic Medicine Unit by Female Victims of Violence
Acronym: VIGITRAUMA
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