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

Primary Purpose

Post-Traumatic Stress Disorder, Violence-Related Symptom

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Vigitrauma
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring Post-Traumatic Stress Disorder, Women Health, Physical Abuse, Forensic Medicine, Case-Management Algorithm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University Hospital, Amiens
  • General Hospital, Boulogne sur Mer
  • University Hospital, Caen
  • General Hospital, Creil
  • University Hospital, LilleRecruiting
  • University Hospital, Rouen
  • General Hospital, Saint-Quentin
  • General Hospital, Valenciennes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vigitrauma

Control group

Arm 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.

Usual follow-up.

Outcomes

Primary Outcome Measures

Clinical Outcome
Rate of patients with a Clinical Global Impression (CGI) severity scale < 4
Clinical Outcome
Rate of patients with a Clinical Global Impression (CGI) severity scale < 4
Clinical Outcome
Rate of patients with a Clinical Global Impression (CGI) severity scale < 4

Secondary Outcome Measures

Severity of post-traumatic stress disorder symptoms
Post-traumatic stress disorder Checklist Scale-5
General psychopathology
French version of Mini International Neuropsychiatric Interview (DSM 5)
Severity of somatic symptoms
Physical Health Questionnaire (PHQ-15)
Medical cost
Nnumber of hospitalizations, consultations, and drugs consummation
Judicial outcome
Number of days of temporary inability to work
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.
Number of suicide attempters
Suicide risk

Full Information

First Posted
June 4, 2021
Last Updated
April 4, 2022
Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT04953273
Brief Title
A Case Management Algorithm for Women Victims of Violence
Acronym
VIGITRAUMA
Official Title
Effectiveness of a Case Management Algorithm on Clinical Outcome After Consultations Requested in a Clinical Forensic Medicine Unit by Female Victims of Violence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2021 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder, Violence-Related Symptom
Keywords
Post-Traumatic Stress Disorder, Women Health, Physical Abuse, Forensic Medicine, Case-Management Algorithm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
756 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vigitrauma
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual follow-up.
Intervention Type
Other
Intervention Name(s)
Vigitrauma
Intervention Description
Case management algorithm using early phone contact
Primary Outcome Measure Information:
Title
Clinical Outcome
Description
Rate of patients with a Clinical Global Impression (CGI) severity scale < 4
Time Frame
3 months
Title
Clinical Outcome
Description
Rate of patients with a Clinical Global Impression (CGI) severity scale < 4
Time Frame
6 months
Title
Clinical Outcome
Description
Rate of patients with a Clinical Global Impression (CGI) severity scale < 4
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Severity of post-traumatic stress disorder symptoms
Description
Post-traumatic stress disorder Checklist Scale-5
Time Frame
3 months, 6 months and 12 months
Title
General psychopathology
Description
French version of Mini International Neuropsychiatric Interview (DSM 5)
Time Frame
3 months, 6 months and 12 months
Title
Severity of somatic symptoms
Description
Physical Health Questionnaire (PHQ-15)
Time Frame
3 months, 6 months and 12 months
Title
Medical cost
Description
Nnumber of hospitalizations, consultations, and drugs consummation
Time Frame
12 months
Title
Judicial outcome
Description
Number of days of temporary inability to work
Time Frame
12 months
Title
Suicidal ideation intensity
Description
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
Title
Number of suicide attempters
Description
Suicide risk
Time Frame
12 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnaud Leroy, MD
Phone
+33 320444460
Email
arnaud.leroy@chru-lille.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Laure Demarty
Phone
+33 320444145
Email
anne-laure.demarty@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud Leroy, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Amiens
City
Amiens
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile MANAOUIL
First Name & Middle Initial & Last Name & Degree
Gaetan PRISSETTE
Facility Name
General Hospital, Boulogne sur Mer
City
Boulogne-sur-Mer
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane CHOCHOIS
Facility Name
University Hospital, Caen
City
Caen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grégoire MOUTEL
Facility Name
General Hospital, Creil
City
Creil
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georges PATRU
First Name & Middle Initial & Last Name & Degree
Marie-Laure CLINET
Facility Name
University Hospital, Lille
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yann DELANNOY
Facility Name
University Hospital, Rouen
City
Rouen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles TOURNEL
Facility Name
General Hospital, Saint-Quentin
City
Saint-Quentin
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabien DELFORGE
Facility Name
General Hospital, Valenciennes
City
Valenciennes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric LAURIER

12. IPD Sharing Statement

Learn more about this trial

A Case Management Algorithm for Women Victims of Violence

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