A Case Management Algorithm for Women Victims of Violence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

756 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-06

Study Completion Date

2026-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Post-Traumatic Stress Disorder Violence-Related Symptom

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Vigitrauma

Intervention Type OTHER

Case management algorithm using early phone contact

Control group

Usual follow-up.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vigitrauma

Case management algorithm using early phone contact

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arnaud Leroy, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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