NCT04731701已完成不适用
Psychometric Validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST)
Swedish Orphan Biovitrum1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2021年5月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Psychometric validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST).
研究概览
简要总结
The purpose of this study is to validate the newly developed Hemophilia Functional Ability Scoring Tool (Hemo-FAST), which is a fast and simple scoring in haemophilia able to assess patient-reported functional mobility.
详细描述
The purpose of this study is to validate the newly developed Hemophilia Functional Ability Scoring Tool (Hemo-FAST), which is a fast and simple scoring in haemophilia able to assess patient-reported functional mobility for adult haemophilia patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •A patient must fulfil the following criteria in order to be included in the study:
- •Age ≥18 years.
- •Diagnosis of haemophilia A or B.
- •Capable of completing the study Patient-Reported Outcome (PRO) questionnaires in French.
- •Signed informed consent.
排除标准
- •The presence of any of the following criteria will exclude a patient from inclusion in the study:
- •Joint replacement within last 6 months.
- •Patients with a non-resolved joint or muscle bleeding event at the enrolment visit or ≤ 7 days prior to the enrolment visit.
- •Patients with comorbid illnesses such as juvenile arthritis, muscular dystrophy, neurologic illness/cognitive impairment, or other illnesses that may independently affect HJHS and Hemo-FAST scores and/or limit the ability of the patient to participate in the study as determined by the investigator.
结局指标
主要结局
Psychometric validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST).
时间窗: Baseline
Statistical analysis to confirm the psychometric validation of the Hemo-FAST questionnaire
次要结局
未报告次要终点
研究者
研究点 (1)
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