Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in patient reported relevancy of the PROVEN Questionnaire
研究概览
简要总结
The purpose of this study is to develop a standardized assessment for patients treated for venous malformations (VM).
Venous malformations result from the abnormal development of veins which may result in pain, swelling, bleeding, functional impairment, disfigurement, and psychological distress. The impact of VM on patient quality of life varies based on the location and size of the malformation.
A patient reported outcome (PRO) is a patient's own account of patient's health condition. PRO measures are valued to clinicians, as many treatment effects are known only to the patient. No studies to date have analyzed the validity of existing PRO measures for VM patients.
Current assessment does not include all symptoms or take in to account the relevance of VM location. Past studies show a discrepancy between treatment outcomes reported by patients and physicians. Therefore, there is a need to develop VM-specific PROs to better understand the effectiveness and benefits of treatment for VM.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female pediatric patients, aged between 0-17 with diagnosis of vascular malformations.
- •Male and Female adult patients aged 18-100 with diagnosis of vascular malformations.
- •Vascular malformation symptoms significant enough to seek treatment.
排除标准
- •Patients with extensive VM not suitable for sclerotherapy.
- •Prior therapy for treatment of a VM within 3 months.
- •Condition or impairment that may render the patient unable to take part in the study (e.g. cognitive, sight, hearing, etc.).
结局指标
主要结局
Change in patient reported relevancy of the PROVEN Questionnaire
时间窗: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Patients are asked to rate the personal relevancy and clarity of the survey questions with the options "Not at all", "A little bit", "Somewhat", "Quite a bit" or "Very Much".
Change in patient reported VM pain
时间窗: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Patients are asked to rate pain associated with VM during the past seven days on a 0-10 scale.
Change in patient reported efficacy of treatment
时间窗: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Patients are asked to rate the efficacy of their treatment with the options "Not at all", "A little bit", "Somewhat", "Quite a bit" or "Very Much".
Change in patient reported VM impact on daily life
时间窗: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Patients are asked to rate the impact that their VM has on daily life with the options "Not at all", "A little bit", "Somewhat", "Quite a bit" or "Very Much".
次要结局
未报告次要终点