Management of Health-Related Quality of LIfe Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,300
- 试验地点
- 1
- 主要终点
- Duration of anti-depressive medications as measured by expected doses of medicines.
研究概览
简要总结
The puropse of this non-interventional register and survey study is to identify the patterns of prescribed pain, anti-depressive and anti-anxiety medication and management of pain, depression and anxiety for people with haemophilia. The study will be conducted in the Nordic countries (Sweden, Norway, Denmark, Finland) and the aim is to cover the entire haemophilia population in the register part of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Part A population will be defined by having:
- •at least one health care contact with main diagnosis haemophilia A or haemophilia B, and/or;
- •at least one prescription of factor VIII or factor IX concentrates, or;
- •bypassing agents used in the treatment of PwH during the inclusion period.
- •Part B1 population: Relevant physician at each HTC with direct and frequent patient contact.
- •Part B2 population: PwH 5 years or older listed at participating HTCs
排除标准
- 未提供
结局指标
主要结局
Duration of anti-depressive medications as measured by expected doses of medicines.
时间窗: Retrospectively 10 years
Based on Registry data
Pharmacological and non-pharmacological treatments for management of HRQoL impairment, including treatment of anxiety
时间窗: Inclusion in survey study
Assessed by HCP survey in Part B1
The perspective and experience of HCPs with direct and frequent patient Contacts on the strategies for the management of HRQoL impairment, including treatment of pain at each Haemophlia Treatment Centre
时间窗: Inclusion in survey study
Assessed by HCP survey in Part B1
The perspective and experience of HCPs with direct and frequent patient Contacts on the strategies for the management of HRQoL impairment, including treatment of anxiety at each Haemophlia Treatment Centre
时间窗: Inclusion in survey study
Assessed by HCP survey in Part B1
Use of medication for pain, depression and anxiety (yes/no?)
时间窗: Retrospectively 10 years
Based on Registry data
Annualised consumption of anti-anxiety medications as assessed by filled prescription
时间窗: Retrospectively 10 years
Based on Registry data
Annualised consumption of anti-depressive medications as assessed by filled prescription
时间窗: Retrospectively 10 years
Based on Registry data
Pharmacological and non-pharmacological treatments for management of HRQoL impairment, including treatment of depression
时间窗: Inclusion in survey study
Assessed by HCP survey in Part B1
Euro-QoL 5 Dimensions 5 Levels (EQ-5D-5L)
时间窗: Inclusion in survey study
Assessed by patient survey in Part B2
Patient satisfaction with current management of depression
时间窗: Inclusion in survey study
Assessed by patient survey in Part B2
Patient satisfaction of received treatment for pain
时间窗: Inclusion in Survey study
Assessed by patient survey in Part B2
Annualised consumption of pain medications as assessed by filled prescription
时间窗: Retrospectively 10 years
Based on Registry data
Duration of anti-anxiety medications as measured by expected doses of medicines.
时间窗: Retrospectively 10 years
Based on Registry data
Duration of pain medications as measured by expected doses of medicines.
时间窗: Retrospectively 10 years
Based on Registry data
Pharmacological and non-pharmacological treatments for management of Health-Related Quality of Life (HRQoL) impairment, including treatment of pain
时间窗: Inclusion in survey study
Assessed by Health Care Professional (HCP) survey in Part B1
Self-reported current and previous use of medications for anxiety
时间窗: Inclusion in survey study
Assessed by patient survey in Part B2
Patient satisfaction of received treatment for depression
时间窗: Inclusion in Survey study
Assessed by patient survey in Part B2
The perspective and experience of HCPs with direct and frequent patient Contacts on the strategies for the management of HRQoL impairment, including treatment of depression at each Haemophlia Treatment Centre
时间窗: Inclusion in survey study
Assessed by HCP survey in Part B1
Self-reported current and previous use of medications for depression
时间窗: Inclusion in survey study
Assessed by patient survey in Part B2
Social and physical activity level
时间窗: Inclusion in survey study
Assessed by patient survey in Part B2
Patient satisfaction with current management of pain
时间窗: Inclusion in survey study
Assessed by patient survey in Part B2
Patient satisfaction with current management anxiety
时间窗: Inclusion in survey study
Assessed by patient survey in Part B2
Patient satisfaction of received treatment for anxiety
时间窗: Inclusion in Survey study
Assessed by patient survey in Part B2
Self-reported current and previous use of medications for pain
时间窗: Inclusion in survey study
Assessed by patient survey in Part B2
次要结局
未报告次要终点