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临床试验/NCT04953273
NCT04953273招募中不适用

Effectiveness of a Case Management Algorithm on Clinical Outcome After Consultations Requested in a Clinical Forensic Medicine Unit by Female Victims of Violence

University Hospital, Lille8 个研究点 分布在 1 个国家目标入组 756 人开始时间: 2021年7月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
756
试验地点
8
主要终点
Clinical Outcome

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Do no consent to participate to the study
  • •Intrafamilial or intimate partner violence
  • •Do not speak french

研究组 & 干预措施

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.

干预措施: Vigitrauma (Other)

Control group

No Intervention

Usual follow-up.

结局指标

主要结局

Clinical Outcome

时间窗: 12 months

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

Clinical Outcome

时间窗: 3 months

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

Clinical Outcome

时间窗: 6 months

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

次要结局

  • Severity of somatic symptoms(3 months, 6 months and 12 months)
  • Severity of post-traumatic stress disorder symptoms(3 months, 6 months and 12 months)
  • Suicidal ideation intensity(12 months)
  • Medical cost(12 months)
  • Judicial outcome(12 months)
  • Number of suicide attempters(12 months)
  • General psychopathology(3 months, 6 months and 12 months)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (8)

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