Clinical trial NCT02568202: Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)
Official title: Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Haemostasis
Congenital Bleeding Disorder
Haemophilia B
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2015-10-05
Enrollment: 449
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility 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

Primary outcomes:
measure: An online survey of Prevalence and characteristics of adults with hemophilia B
timeFrame: At day 0
measure: An online survey of Prevalence and characteristics of children with hemophilia B (and their parents)
timeFrame: At day 0
measure: An online survey of Prevalence of psychosocial and other comorbidities in patients with hemophilia B
timeFrame: At day 0
Secondary outcomes:
measure: Percentage of participants reporting difficulty with access to treatment (e.g. factor)
timeFrame: At day 0
measure: An online survey of Percentage of participants reporting difficulty with access to treatment centers
timeFrame: At day 0
measure: Percentage of participants reporting hemophilia interference with employment/education
timeFrame: At day 0
measure: Percentage of participants reporting hemophilia interference with physical activities
timeFrame: At day 0
measure: Percentage of participants reporting hemophilia interference with relationships
timeFrame: At day 0
measure: Health related quality of life: EuroQol
timeFrame: At day 0
measure: Health related quality of life:EQ-5D-5L
timeFrame: At day 0
measure: Health related quality of life: VAS (Visual Analog Scale)
timeFrame: At day 0
measure: Health related quality of life: BPI (Brief Pain Inventory) short form - Pain severity and interference
timeFrame: At day 0
measure: Health related quality of life: HAL (Hemophilia Activities List)
timeFrame: At day 0
measure: Health related quality of life: HemoCAB (Caregiver Hemophilia Burden Scale
timeFrame: At day 0
measure: Drivers of psychosocial impact (e.g. hemophilia severity, age, weight, prior treatment history, education)
timeFrame: At day 0
Other outcomes:
Locations:
city: Plainsboro
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: New Jersey
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: