NCT02568202CompletedNot Applicable
Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 449
- Locations
- 1
- Primary Endpoint
- An online survey of Prevalence and characteristics of adults with hemophilia B
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
An online survey of Prevalence and characteristics of adults with hemophilia B
Time Frame: At day 0
An online survey of Prevalence and characteristics of children with hemophilia B (and their parents)
Time Frame: At day 0
An online survey of Prevalence of psychosocial and other comorbidities in patients with hemophilia B
Time Frame: At day 0
Secondary Outcomes
- Percentage of participants reporting difficulty with access to treatment (e.g. factor)(At day 0)
- An online survey of Percentage of participants reporting difficulty with access to treatment centers(At day 0)
- Percentage of participants reporting hemophilia interference with employment/education(At day 0)
- Percentage of participants reporting hemophilia interference with physical activities(At day 0)
- Percentage of participants reporting hemophilia interference with relationships(At day 0)
- Health related quality of life: EuroQol(At day 0)
- Health related quality of life:EQ-5D-5L(At day 0)
- Health related quality of life: VAS (Visual Analog Scale)(At day 0)
- Health related quality of life: BPI (Brief Pain Inventory) short form - Pain severity and interference(At day 0)
- Health related quality of life: HAL (Hemophilia Activities List)(At day 0)
- Health related quality of life: HemoCAB (Caregiver Hemophilia Burden Scale(At day 0)
- Drivers of psychosocial impact (e.g. hemophilia severity, age, weight, prior treatment history, education)(At day 0)
Investigators
Study Sites (1)
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