NCT03276130

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 30, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

September 7, 2017

Last Update Submit

March 5, 2024

Conditions

Haemophilia AHaemophilia B

Keywords

Blood coagulation disorderHaematologic diseasesCoagulation protein disorderHemorrhagic disorderGenetic diseases, inbornPainAnxietyPain medicationAnxiety medication

Outcome Measures

Primary Outcomes (24)

  • 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

Study Arms (3)

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.

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.

Part B2: Survey to PwH

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

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All PwH in Sweden, Norway, Denmark and Finland

You may qualify if:

  • 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;
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Swedish Orphan Biovitrum Research Site

Copenhagen, Denmark

Location

Swedish Orphan Biovitrum Research Site

Helsinki, Finland

Location

Swedish Orphan Biovitrum Research Site

Gothenburg, Sweden

Location

Swedish Orphan Biovitrum Research Site

Malmo, Sweden

Location

Swedish Orphan Biovitrum Research Site

Stockholm, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 40099856DERIVED

  • 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.

    PMID: 35460313DERIVED

MeSH Terms

Conditions

Hemophilia AHemophilia BBlood Coagulation DisordersCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornPainAnxiety Disorders

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedHematologic DiseasesHemic and Lymphatic DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-LinkedNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 8, 2017

Study Start

October 30, 2018

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations

FI(1)SE(3)DK(1)