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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03276130
Recruitment Status : Completed
First Posted : September 8, 2017
Last Update Posted : July 17, 2020
Sponsor:
Information provided by (Responsible Party):
Swedish Orphan Biovitrum

Study Description
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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.

Condition or disease
Haemophilia A Haemophilia B

Study Design
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Study Type : Observational
Actual Enrollment : 2300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Management of Health-Related Quality of LIfe Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B
Actual Study Start Date : October 30, 2018
Actual Primary Completion Date : January 30, 2020
Actual Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Hemophilia

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All PwH in Sweden, Norway, Denmark and Finland
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276130


Locations
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Denmark
Swedish Orphan Biovitrum Research Site
Copenhagen, Denmark
Finland
Swedish Orphan Biovitrum Research Site
Helsinki, Finland
Sweden
Swedish Orphan Biovitrum Research Site
Göteborg, Sweden
Swedish Orphan Biovitrum Research Site
Malmö, Sweden
Swedish Orphan Biovitrum Research Site
Stockholm, Sweden
Sponsors and Collaborators
Swedish Orphan Biovitrum
Investigators
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Study Director: Bent Winding Swedish Orphan Biovitrum
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier: NCT03276130    
Other Study ID Numbers: Sobi.HAEM89-003
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020
Keywords provided by Swedish Orphan Biovitrum:
Blood coagulation disorder
Haematologic diseases
Coagulation protein disorder
Hemorrhagic disorder
Genetic diseases, inborn
 Pain
Anxiety
Pain medication
Anxiety medication
Additional relevant MeSH terms:
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Hemophilia A
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked