A Case Management Algorithm for Women Victims of Violence (VIGITRAUMA)
Effectiveness of a Case Management Algorithm on Clinical Outcome After Consultations Requested in a Clinical Forensic Medicine Unit by Female Victims of Violence
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Arnaud Leroy, MD
- Telefonnummer: +33 320444460
- E-mail: arnaud.leroy@chru-lille.fr
Undersøgelse Kontakt Backup
- Navn: Anne-Laure Demarty
- Telefonnummer: +33 320444145
- E-mail: anne-laure.demarty@chru-lille.fr
Studiesteder
-
-
-
Amiens, Frankrig
- Ikke rekrutterer endnu
- University Hospital, Amiens
-
Ledende efterforsker:
- Cécile MANAOUIL
-
Underforsker:
- Gaetan PRISSETTE
-
Boulogne-sur-Mer, Frankrig
- Ikke rekrutterer endnu
- General Hospital, Boulogne sur Mer
-
Ledende efterforsker:
- Stéphane CHOCHOIS
-
Caen, Frankrig
- Ikke rekrutterer endnu
- University Hospital, Caen
-
Ledende efterforsker:
- Grégoire MOUTEL
-
Creil, Frankrig
- Ikke rekrutterer endnu
- General Hospital, Creil
-
Ledende efterforsker:
- Georges PATRU
-
Underforsker:
- Marie-Laure CLINET
-
Lille, Frankrig
- Rekruttering
- University Hospital, Lille
-
Ledende efterforsker:
- Yann DELANNOY
-
Rouen, Frankrig
- Ikke rekrutterer endnu
- University Hospital, Rouen
-
Ledende efterforsker:
- Gilles TOURNEL
-
Saint-Quentin, Frankrig
- Ikke rekrutterer endnu
- General Hospital, Saint-Quentin
-
Ledende efterforsker:
- Fabien DELFORGE
-
Valenciennes, Frankrig
- Ikke rekrutterer endnu
- General Hospital, Valenciennes
-
Ledende efterforsker:
- Eric LAURIER
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
Case management algorithm using early phone contact
|
|
Ingen indgriben: Control group
Usual follow-up.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical Outcome
Tidsramme: 3 months
|
Rate of patients with a Clinical Global Impression (CGI) severity scale < 4
|
3 months
|
|
Clinical Outcome
Tidsramme: 6 months
|
Rate of patients with a Clinical Global Impression (CGI) severity scale < 4
|
6 months
|
|
Clinical Outcome
Tidsramme: 12 months
|
Rate of patients with a Clinical Global Impression (CGI) severity scale < 4
|
12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Severity of post-traumatic stress disorder symptoms
Tidsramme: 3 months, 6 months and 12 months
|
Post-traumatic stress disorder Checklist Scale-5
|
3 months, 6 months and 12 months
|
|
General psychopathology
Tidsramme: 3 months, 6 months and 12 months
|
French version of Mini International Neuropsychiatric Interview (DSM 5)
|
3 months, 6 months and 12 months
|
|
Severity of somatic symptoms
Tidsramme: 3 months, 6 months and 12 months
|
Physical Health Questionnaire (PHQ-15)
|
3 months, 6 months and 12 months
|
|
Medical cost
Tidsramme: 12 months
|
Nnumber of hospitalizations, consultations, and drugs consummation
|
12 months
|
|
Judicial outcome
Tidsramme: 12 months
|
Number of days of temporary inability to work
|
12 months
|
|
Suicidal ideation intensity
Tidsramme: 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.
|
12 months
|
|
Number of suicide attempters
Tidsramme: 12 months
|
Suicide risk
|
12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Arnaud Leroy, MD, University Hospital, Lille
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2020_ 01
- 2020-A02591-38 (Anden identifikator: ID-RCB number, ANSM)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .