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

NCT ID: NCT03276130

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-30

Study Completion Date

2020-01-30

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.

Detailed Description

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Conditions

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Haemophilia A Haemophilia B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Part A: Retrospective register study

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.

No interventions assigned to this group

Part B1: Survey to HTC

The survey will be sent out to the relevant physician at each Haemophilia Treatment Centers (HTC) with direct and frequent patient contacts.

No interventions assigned to this group

Part B2: Survey to PwH

All People with Haemophilia (PwH) listed at HTCs will be invited to participate in the patient survey.

No interventions assigned to this group

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
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Orphan Biovitrum

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Swedish Orphan Biovitrum Research Site

Copenhagen, , Denmark

Site Status

Swedish Orphan Biovitrum Research Site

Helsinki, , Finland

Site Status

Swedish Orphan Biovitrum Research Site

Gothenburg, , Sweden

Site Status

Swedish Orphan Biovitrum Research Site

Malmo, , Sweden

Site Status

Swedish Orphan Biovitrum Research Site

Stockholm, , Sweden

Site Status

Countries

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Denmark Finland Sweden

References

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Steen Carlsson K, Astermark J, Baghaei F, Brodin E, Funding E, Holmstrom M, Osterholm K, Bergenstrale S, Lethagen S. Comorbidity and Mortality in Men and Women With Haemophilia in Three Nordic Countries-Comparisons to Matched Controls. Haemophilia. 2025 May;31(3):401-411. doi: 10.1111/hae.70023. Epub 2025 Mar 18.

Reference Type DERIVED
PMID: 40099856 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35460313 (View on PubMed)

Other Identifiers

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Sobi.HAEM89-003

Identifier Type: -

Identifier Source: org_study_id

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