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

Completed

• Conditions: Haemophilia A; Haemophilia B

• Registration Number: NCT03276130
• Lead Sponsor: Swedish Orphan Biovitrum

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-07
• Study First Submitted QC: 2017-09-07
• Study First Posted: 2017-09-08
• Study Start: 2018-10-30
• Primary Completion: 2020-01-30
• Study Completion: 2020-01-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Swedish Orphan Biovitrum Research Site; 🇸🇪 Stockholm, Sweden