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Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)

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: NCT02568202
Recruitment Status : Completed
First Posted : October 5, 2015
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study is conducted in the United States of America (USA). Tha aim of this study is bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S).

Condition or disease Intervention/treatment
Haemostasis Congenital Bleeding Disorder Haemophilia B Other: No treatment given

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Study Type : Observational
Actual Enrollment : 449 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)
Study Start Date : September 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Survey Other: No treatment given

This is an online web-based cross-sectional survey in which participants will complete one of two questionnaires.

There will be no treatment.





Primary Outcome Measures :
  1. An online survey of Prevalence and characteristics of adults with hemophilia B [ Time Frame: At day 0 ]
  2. An online survey of Prevalence and characteristics of children with hemophilia B (and their parents) [ Time Frame: At day 0 ]
  3. An online survey of Prevalence of psychosocial and other comorbidities in patients with hemophilia B [ Time Frame: At day 0 ]

Secondary Outcome Measures :
  1. Percentage of participants reporting difficulty with access to treatment (e.g. factor) [ Time Frame: At day 0 ]
  2. An online survey of Percentage of participants reporting difficulty with access to treatment centers [ Time Frame: At day 0 ]
  3. Percentage of participants reporting hemophilia interference with employment/education [ Time Frame: At day 0 ]
  4. Percentage of participants reporting hemophilia interference with physical activities [ Time Frame: At day 0 ]
  5. Percentage of participants reporting hemophilia interference with relationships [ Time Frame: At day 0 ]
  6. Health related quality of life: EuroQol [ Time Frame: At day 0 ]
  7. Health related quality of life:EQ-5D-5L [ Time Frame: At day 0 ]
  8. Health related quality of life: VAS (Visual Analog Scale) [ Time Frame: At day 0 ]
  9. Health related quality of life: BPI (Brief Pain Inventory) short form - Pain severity and interference [ Time Frame: At day 0 ]
  10. Health related quality of life: HAL (Hemophilia Activities List) [ Time Frame: At day 0 ]
  11. Health related quality of life: HemoCAB (Caregiver Hemophilia Burden Scale [ Time Frame: At day 0 ]
  12. Drivers of psychosocial impact (e.g. hemophilia severity, age, weight, prior treatment history, education) [ Time Frame: At day 0 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study will investigate adult patients at least 18 years of age with mild-severe hemophilia B and caregivers of children (current age below 18 years) with hemophilia B.
Criteria

Inclusion Criteria:

  • Adults aged below or equal to 18 years with hemophilia B (any severity, with or without inhibitors)
  • Caregivers of children currently aged below 18 years with hemophilia B (any severity, with or without inhibitors)
  • Subjects must have access to the internet, either at home or at a location convenient to them
  • Provision of informed consent before the start of any survey-related activities

Exclusion Criteria:

  • Inability to understand and comply with written instructions in English
  • Previous completion of the B-HERO-S study with receipt of compensation
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

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): NCT02568202


Locations
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United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Plainsboro, New Jersey, United States, 08536
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02568202     History of Changes
Other Study ID Numbers: HAEM-4268
U1111-1171-8168 ( Other Identifier: WHO )
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Hemostatic Disorders
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases