Management of Health-Related QoL Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B

Study Overview
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Brief Summary
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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.

Official Title
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Management of Health-Related Quality of LIfe Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B

Conditions
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Haemophilia A, Haemophilia B

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: NA

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Part A: Retrospective register study<br>To describe the usage of prescribed pain, anti-depressive and anti-anxiety medication during a 10-year period based on retrospective data from patient and drug registries. Population: All People with Haemophilia A and B identified through national administrative register or from local register at each treatment centre. The People with Haemophilia group will be compared against an age and gender matched control group from the general population. | |
| Part B1: Survey to HTC<br>The survey will be sent out to the relevant physician at each Haemophilia Treatment Centers (HTC) with direct and frequent patient contacts. | |
| Part B2: Survey to PwH<br>All People with Haemophilia (PwH) listed at HTCs will be invited to participate in the patient survey. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of medication for pain, depression and anxiety (yes/no?) | Based on Registry data | Retrospectively 10 years | 
| Annualised consumption of pain medications as assessed by filled prescription | Based on Registry data | Retrospectively 10 years | 
| Annualised consumption of anti-anxiety medications as assessed by filled prescription | Based on Registry data | Retrospectively 10 years | 
| Annualised consumption of anti-depressive medications as assessed by filled prescription | Based on Registry data | Retrospectively 10 years | 
| Duration of pain medications as measured by expected doses of medicines. | Based on Registry data | Retrospectively 10 years | 
| Duration of anti-depressive medications as measured by expected doses of medicines. | Based on Registry data | Retrospectively 10 years | 
| Duration of anti-anxiety medications as measured by expected doses of medicines. | Based on Registry data | Retrospectively 10 years | 
| Pharmacological and non-pharmacological treatments for management of Health-Related Quality of Life (HRQoL) impairment, including treatment of pain | Assessed by Health Care Professional (HCP) survey in Part B1 | Inclusion in survey study | 
| Pharmacological and non-pharmacological treatments for management of HRQoL impairment, including treatment of anxiety | Assessed by HCP survey in Part B1 | Inclusion in survey study | 
| Pharmacological and non-pharmacological treatments for management of HRQoL impairment, including treatment of depression | Assessed by HCP survey in Part B1 | Inclusion in survey study | 
| 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 | Assessed by HCP survey in Part B1 | Inclusion in survey study | 
| 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 | Assessed by HCP survey in Part B1 | Inclusion in survey study | 
| 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 | Assessed by HCP survey in Part B1 | Inclusion in survey study | 
| Self-reported current and previous use of medications for pain | Assessed by patient survey in Part B2 | Inclusion in survey study | 
| Self-reported current and previous use of medications for anxiety | Assessed by patient survey in Part B2 | Inclusion in survey study | 
| Self-reported current and previous use of medications for depression | Assessed by patient survey in Part B2 | Inclusion in survey study | 
| Social and physical activity level | Assessed by patient survey in Part B2 | Inclusion in survey study | 
| Euro-QoL 5 Dimensions 5 Levels (EQ-5D-5L) | Assessed by patient survey in Part B2 | Inclusion in survey study | 
| Patient satisfaction with current management of pain | Assessed by patient survey in Part B2 | Inclusion in survey study | 
| Patient satisfaction with current management anxiety | Assessed by patient survey in Part B2 | Inclusion in survey study | 
| Patient satisfaction with current management of depression | Assessed by patient survey in Part B2 | Inclusion in survey study | 
| Patient satisfaction of received treatment for pain | Assessed by patient survey in Part B2 | Inclusion in Survey study | 
| Patient satisfaction of received treatment for anxiety | Assessed by patient survey in Part B2 | Inclusion in Survey study | 
| Patient satisfaction of received treatment for depression | Assessed by patient survey in Part B2 | Inclusion in Survey study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood coagulation disorder, Haematologic diseases, Coagulation protein disorder, Hemorrhagic disorder, Genetic diseases, inborn, Pain, Anxiety, Pain medication, Anxiety medication