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

January 11, 2016 updated by: Novo Nordisk A/S
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

449

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Plainsboro, New Jersey, United States, 08536
        • Novo Nordisk Clinical Trial Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
An online survey of Prevalence and characteristics of adults with hemophilia B
Time Frame: At day 0
At day 0
An online survey of Prevalence and characteristics of children with hemophilia B (and their parents)
Time Frame: At day 0
At day 0
An online survey of Prevalence of psychosocial and other comorbidities in patients with hemophilia B
Time Frame: At day 0
At day 0

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

September 18, 2015

First Submitted That Met QC Criteria

October 1, 2015

First Posted (Estimate)

October 5, 2015

Study Record Updates

Last Update Posted (Estimate)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 11, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAEM-4268
  • U1111-1171-8168 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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