HEAD-US SCORING SYSTEM: Assessment of the Real-world Impact of Ultrasound on Disease Management and Treatment Decision-making in Moderate and Severe Haemophilia
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- Any change in treatment
研究概览
简要总结
Ultrasound represents a promising technique for the assessment of joint health in persons with haemophilia (PWH) by non-imaging specialists. The Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) programme has been developed with the aim of integrating joint ultrasound in the routine assessment of PWH through the use of a simplified scoring system. The inter-operator reliability of the technique among European haemophilia treaters has been validated and described elsewhere. Further work is needed to assess the real-world impact of ultrasound on disease management and treatment decision-making.
详细描述
Patients are seen routinely in clinic by specialist haemophilia physiotherapists who assess the patients using the Haemophilia Joint Health Score tool (HJHS). Trial participants will be seen during their routine clinic visits and will be seen by a clinician and the physiotherapist who will carry out the routine assessment along with the HEAD-US scan.
Patients will be seen a maximum of 4 times throughout the year from registration of the first patient, according to their visit schedule, but will only be scanned at the first visit.
Results will be analysed to determine if the treatment decision-making is influenced by the results of the scan
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate (FVIII/FIX:C 1-5%) and severe (FVIII/FIX: C <1%) patients with haemophilia A or B aged ≥ 6 years
- •On demand or prophylaxis treatment regimen
排除标准
- •Joints with a previous history of surgery
- •Joints with damage as a result of causes other than haemophilia-related bleeding
研究组 & 干预措施
Single
All patients will undergo ultrasound scan using the HEAD-US Scoring System by a non-imaging specialist
干预措施: HEAD-US scoring system (Other)
结局指标
主要结局
Any change in treatment
时间窗: 12 months
Any change in treatment including, management of a bleed and/or change in routine treatment protocol (including changes to prophylaxis regimen, or decision to start/stop prophylaxis regimen) as a result of the ultrasound findings
次要结局
- % joints with normal HJHS and abnormal HEAD-US score(12 months)
- % joints with abnormal HJHS and normal HEAD-US score(12 months)