Brief Title
Management of Health-Related QoL Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B
Official Title
Management of Health-Related Quality of LIfe Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B
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.
Study Type
Observational
Primary Outcome
Use of medication for pain, depression and anxiety (yes/no?)
Condition
Haemophilia A
Study Arms / Comparison Groups
Part A: Retrospective register study
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
2300
Start Date
October 30, 2018
Completion Date
January 30, 2020
Primary Completion Date
January 30, 2020
Eligibility Criteria
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
Gender
All
Ages
5 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Bent Winding, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT03276130
Organization ID
Sobi.HAEM89-003
Responsible Party
Sponsor
Study Sponsor
Swedish Orphan Biovitrum
Study Sponsor
Bent Winding, Study Director, Swedish Orphan Biovitrum
Verification Date
July 2020