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Completed

NCT Number: NCT03276130

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

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.

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Key information

Conditions

Haemophilia A Anxiety Disorders Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Haemophilia B Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemophilia B Hemorrhagic Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Swedish Orphan Biovitrum Research Site, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Use of medication for pain, depression and anxiety (yes/no?)

    Time frame: Retrospectively 10 years

    Based on Registry data

  2. Annualised consumption of pain medications as assessed by filled prescription

    Time frame: Retrospectively 10 years

    Based on Registry data

  3. Annualised consumption of anti-anxiety medications as assessed by filled prescription

    Time frame: Retrospectively 10 years

    Based on Registry data

  4. Annualised consumption of anti-depressive medications as assessed by filled prescription

    Time frame: Retrospectively 10 years

    Based on Registry data

  5. Duration of pain medications as measured by expected doses of medicines.

    Time frame: Retrospectively 10 years

    Based on Registry data

  6. Duration of anti-depressive medications as measured by expected doses of medicines.

    Time frame: Retrospectively 10 years

    Based on Registry data

  7. Duration of anti-anxiety medications as measured by expected doses of medicines.

    Time frame: Retrospectively 10 years

    Based on Registry data

  8. Pharmacological and non-pharmacological treatments for management of Health-Related Quality of Life (HRQoL) impairment, including treatment of pain

    Time frame: Inclusion in survey study

    Assessed by Health Care Professional (HCP) survey in Part B1

  9. Pharmacological and non-pharmacological treatments for management of HRQoL impairment, including treatment of anxiety

    Time frame: Inclusion in survey study

    Assessed by HCP survey in Part B1

  10. Pharmacological and non-pharmacological treatments for management of HRQoL impairment, including treatment of depression

    Time frame: Inclusion in survey study

    Assessed by HCP survey in Part B1

  11. 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

    Time frame: Inclusion in survey study

    Assessed by HCP survey in Part B1

  12. 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

    Time frame: Inclusion in survey study

    Assessed by HCP survey in Part B1

  13. 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

    Time frame: Inclusion in survey study

    Assessed by HCP survey in Part B1

  14. Self-reported current and previous use of medications for pain

    Time frame: Inclusion in survey study

    Assessed by patient survey in Part B2

  15. Self-reported current and previous use of medications for anxiety

    Time frame: Inclusion in survey study

    Assessed by patient survey in Part B2

  16. Self-reported current and previous use of medications for depression

    Time frame: Inclusion in survey study

    Assessed by patient survey in Part B2

  17. Social and physical activity level

    Time frame: Inclusion in survey study

    Assessed by patient survey in Part B2

  18. Euro-QoL 5 Dimensions 5 Levels (EQ-5D-5L)

    Time frame: Inclusion in survey study

    Assessed by patient survey in Part B2

  19. Patient satisfaction with current management of pain

    Time frame: Inclusion in survey study

    Assessed by patient survey in Part B2

  20. Patient satisfaction with current management anxiety

    Time frame: Inclusion in survey study

    Assessed by patient survey in Part B2

  21. Patient satisfaction with current management of depression

    Time frame: Inclusion in survey study

    Assessed by patient survey in Part B2

  22. Patient satisfaction of received treatment for pain

    Time frame: Inclusion in Survey study

    Assessed by patient survey in Part B2

  23. Patient satisfaction of received treatment for anxiety

    Time frame: Inclusion in Survey study

    Assessed by patient survey in Part B2

  24. Patient satisfaction of received treatment for depression

    Time frame: Inclusion in Survey study

    Assessed by patient survey in Part B2

Sponsors and collaborators

Lead sponsor

Swedish Orphan Biovitrum

Industry

Registry information

Official study title

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

Acronym: MIND

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 8, 2017
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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