Prospective Abuse and Intimate Partner Violence Surgical Evaluation (PRAISE-2) : A Multicentre Pilot Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Feasibility - Proportion of Missed and/or out of window visits
研究概览
简要总结
Intimate partner violence (IPV), also known as domestic abuse, is a leading cause of non-fatal injury in women worldwide. 1 in 6 women attending surgical fracture clinics have a history of IPV in the past year. Given the high prevalence and costs associated with IPV, there is a need to identify health outcomes associated with IPV, the incidence of new and worsening cases of IPV, and resource use among IPV victims. This prospective cohort study of women with fractures and dislocations will assess differences in injury-related outcomes (time to fracture healing, injury-related complications, and return to pre-injury function) between abused and non-abused women. This study will also determine whether a musculoskeletal injury can lead to new or worsening abuse by an intimate partner and how patterns of IPV change over time following musculoskeletal injuries.Finally, the proposed study will also inform the feasibility of a larger multinational cohort study.
详细描述
Number of Participants:
250
Primary Research Objectives:
Feasibility
Secondary Research Objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult females
- •Patients presenting to participating fracture clinics within 6 weeks of their musculoskeletal injury
- •Patients presenting with a fracture or dislocation which is being managed with either surgical or non-surgical treatment
排除标准
- •Unwilling to or unable to provide consent
- •Unable to complete the study questionnaires in a private location
- •Unwilling or unable to follow the study protocol or their attending surgeon has concerns about their ability or willingness to follow study protocols
- •Does not speak and write in English or the dominant language of the local clinic
结局指标
主要结局
Feasibility - Proportion of Missed and/or out of window visits
时间窗: 12 months
Proportion of missed and out of window visits
Feasibility - Collection of secondary outcomes (Proportion of included patients followed at 12 months for the primary and secondary outcomes)
时间窗: 12 months
Proportion of included patients followed at 12 months for the primary and secondary outcomes
Feasibility - Completion of data collection (proportion of case report forms, including patient questionnaires, completed at 12 months)
时间窗: 12 months
The proportion of case report forms, including patient questionnaires, completed at 12 months.
Feasibility - Recruitment rate
时间窗: 12 months
Number of patients recruited at each site during a 12 month period
次要结局
- Proportion of patients with injury-related complications assessed by central adjudication(12 months)
- Return to function questionnaire(12 months)
- Resource use questionnaire(12 months)
- IPV incidence questionnaire(12 months)
- Quality of life - EQ-5D(12 months)
- IPV frequency questionnaire(12 months)
- Stage of change questionnaire(12 months)
- IPV type questionnaire(12 months)