Generating Real-world Ambispective Data to Study Participant Treatment Outcomes for Dupuytren's Contracture
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 130
- 试验地点
- 7
- 主要终点
- Number of Participants Receiving Each Treatment Type for DC
研究概览
简要总结
This is an observational study, meaning participants will not receive any investigational treatment as part of this study.
Researchers will collect real-world data (RWD), based on usual care, to gain a more in-depth knowledge of the natural history and the treatment outcomes of Dupuytren's Contracture (DC) to evaluate the management of DC.
详细描述
Each participant of the study will have their data collected from the date of confirmed diagnosis of DC to the date of enrollment in the registry, post consent. Data will be collected from the participants clinical records as well as from the participant directly. Data will be collected through Pulse Infoframe's technology platform.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any adult with a confirmed clinical diagnosis of DC.
- •Age 18 years (or age of majority in their jurisdiction) or older at time of enrollment.
- •Willing to participate in the registry (including completion of ePROs) and complete the informed consent form.
- •Having received DC treatment, either non-surgical or surgical, within 2 weeks before enrollment, at enrollment or any time after the date of enrollment or not having received DC treatment after confirmed diagnosis of DC.
- •Able to participate in English based registry.
- •Key Exclusion criteria:
- •Not having a clinical diagnosis of DC.
- •Age less than 18 years.
- •Do not provide informed consent.
排除标准
- 未提供
结局指标
主要结局
Number of Participants Receiving Each Treatment Type for DC
时间窗: Up to 36 months
次要结局
- Participant Satisfaction Questionnaire(Up to 36 months)
- Change from Baseline in Michigan Hand Questionnaire (MHQ) Scale Score(Up to 36 months)
- Change from Baseline in European Quality of Life Five Dimension (EQ-5D) Questionnaire Score(Up to 36 months)
- Change from Baseline in Unité Rhumatologique des Affections de la Main (URAM) Scale Score(Up to 36 months)
- Number of Participants Receiving Post-Procedural Care by the Treating Physician(Up to 36 months)