Clinical trial NCT03276130: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Haemophilia A
Haemophilia B
Keywords: Blood coagulation disorder
Haematologic diseases
Coagulation protein disorder
Hemorrhagic disorder
Genetic diseases, inborn
Pain
Anxiety
Pain medication
Anxiety medication
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
First posted: 2017-09-08
Enrollment: 2300
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All PwH in Sweden, Norway, Denmark and Finland

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.


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

Primary outcomes:
measure: Use of medication for pain, depression and anxiety (yes/no?)
timeFrame: Retrospectively 10 years
measure: Annualised consumption of pain medications as assessed by filled prescription
timeFrame: Retrospectively 10 years
measure: Annualised consumption of anti-anxiety medications as assessed by filled prescription
timeFrame: Retrospectively 10 years
measure: Annualised consumption of anti-depressive medications as assessed by filled prescription
timeFrame: Retrospectively 10 years
measure: Duration of pain medications as measured by expected doses of medicines.
timeFrame: Retrospectively 10 years
measure: Duration of anti-depressive medications as measured by expected doses of medicines.
timeFrame: Retrospectively 10 years
measure: Duration of anti-anxiety medications as measured by expected doses of medicines.
timeFrame: Retrospectively 10 years
measure: Pharmacological and non-pharmacological treatments for management of Health-Related Quality of Life (HRQoL) impairment, including treatment of pain
timeFrame: Inclusion in survey study
measure: Pharmacological and non-pharmacological treatments for management of HRQoL impairment, including treatment of anxiety
timeFrame: Inclusion in survey study
measure: Pharmacological and non-pharmacological treatments for management of HRQoL impairment, including treatment of depression
timeFrame: Inclusion in survey study
measure: 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
timeFrame: Inclusion in survey study
measure: 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
timeFrame: Inclusion in survey study
measure: 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
timeFrame: Inclusion in survey study
measure: Self-reported current and previous use of medications for pain
timeFrame: Inclusion in survey study
measure: Self-reported current and previous use of medications for anxiety
timeFrame: Inclusion in survey study
measure: Self-reported current and previous use of medications for depression
timeFrame: Inclusion in survey study
measure: Social and physical activity level
timeFrame: Inclusion in survey study
measure: Euro-QoL 5 Dimensions 5 Levels (EQ-5D-5L)
timeFrame: Inclusion in survey study
measure: Patient satisfaction with current management of pain
timeFrame: Inclusion in survey study
measure: Patient satisfaction with current management anxiety
timeFrame: Inclusion in survey study
measure: Patient satisfaction with current management of depression
timeFrame: Inclusion in survey study
measure: Patient satisfaction of received treatment for pain
timeFrame: Inclusion in Survey study
measure: Patient satisfaction of received treatment for anxiety
timeFrame: Inclusion in Survey study
measure: Patient satisfaction of received treatment for depression
timeFrame: Inclusion in Survey study
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Swedish Orphan Biovitrum Research Site
city: Helsinki
country: Finland
facility: Swedish Orphan Biovitrum Research Site
city: Göteborg
country: Sweden
facility: Swedish Orphan Biovitrum Research Site
city: Malmö
country: Sweden
facility: Swedish Orphan Biovitrum Research Site
city: Stockholm
country: Sweden
facility: Swedish Orphan Biovitrum Research Site
Study officials:
References:
citation: Steen Carlsson K, Winding B, Astermark J, Baghaei F, Brodin E, Funding E, Holmstrom M, Osterholm K, Bergenstrale S, Andersson E, Lethagen S. Pain, depression and anxiety in people with haemophilia from three Nordic countries: Cross-sectional survey data from the MIND study. Haemophilia. 2022 Jul;28(4):557-567. doi: 10.1111/hae.14571. Epub 2022 Apr 23.