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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02591-38 | Other Identifier | ID-RCB number, ANSM |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vigitrauma | Experimental | 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. |
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| Control group | No Intervention | Usual follow-up. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vigitrauma | Other | Case management algorithm using early phone contact |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcome | Rate of patients with a Clinical Global Impression (CGI) severity scale < 4 | 3 months |
| Clinical Outcome | Rate of patients with a Clinical Global Impression (CGI) severity scale < 4 | 6 months |
| Clinical Outcome | Rate of patients with a Clinical Global Impression (CGI) severity scale < 4 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of post-traumatic stress disorder symptoms | Post-traumatic stress disorder Checklist Scale-5 | 3 months, 6 months and 12 months |
| General psychopathology | French version of Mini International Neuropsychiatric Interview (DSM 5) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arnaud Leroy, MD | Contact | +33 320444460 | arnaud.leroy@chru-lille.fr | |
| Anne-Laure Demarty | Contact | +33 320444145 | anne-laure.demarty@chru-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Arnaud Leroy, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Amiens | Not yet recruiting | Amiens | France |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| 3 months, 6 months and 12 months |
| Severity of somatic symptoms | Physical Health Questionnaire (PHQ-15) | 3 months, 6 months and 12 months |
| Medical cost | Nnumber of hospitalizations, consultations, and drugs consummation | 12 months |
| Judicial outcome | Number of days of temporary inability to work | 12 months |
| Suicidal ideation intensity | 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 | Suicide risk | 12 months |
| General Hospital, Boulogne sur Mer | Not yet recruiting | Boulogne-sur-Mer | France |
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| University Hospital, Caen | Not yet recruiting | Caen | France |
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| General Hospital, Creil | Not yet recruiting | Creil | France |
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| University Hospital, Lille | Recruiting | Lille | France |
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| University Hospital, Rouen | Not yet recruiting | Rouen | France |
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| General Hospital, Saint-Quentin | Not yet recruiting | Saint-Quentin | France |
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| General Hospital, Valenciennes | Not yet recruiting | Valenciennes | France |
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