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

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ClinicalTrials.gov Identifier: NCT03276130
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Swedish Orphan Biovitrum

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

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Hemophilia

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.



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



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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

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


Contacts
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Contact: Sofia Bergenstråle +46 8 697 2000 sofia.bergenstrale@sobi.com

Locations
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Denmark
Swedish Orphan Biovitrum Research Site Not yet recruiting
Copenhagen, Denmark
Finland
Swedish Orphan Biovitrum Research Site Not yet recruiting
Helsinki, Finland
Sweden
Swedish Orphan Biovitrum Research Site Completed
Göteborg, Sweden
Swedish Orphan Biovitrum Research Site Completed
Malmö, Sweden
Swedish Orphan Biovitrum Research Site Recruiting
Stockholm, Sweden
Sponsors and Collaborators
Swedish Orphan Biovitrum
Investigators
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Study Director: Bent Winding Swedish Orphan Biovitrum

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Responsible Party: Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier: NCT03276130     History of Changes
Other Study ID Numbers: Sobi.HAEM89-003
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

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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Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Depression
Hemophilia A
Hemophilia B
Behavioral Symptoms
Factor VIII
Coagulants