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