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Survey Evaluating the Psychosocial Effects of Living With Haemophilia (HERO)

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ClinicalTrials.gov Identifier: NCT01322620
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

This study is conducted in Africa, Asia, Europe, North America and South America.

The purpose of the survey is to identify the key psychosocial issues affecting patients with haemophilia.


Condition or disease Intervention/treatment
Congenital Bleeding Disorder Haemophilia A Haemophilia B Haemophilia A With Inhibitors Haemophilia B With Inhibitors Relatives to/Carers of Patients Other: No treatment given

Study Type : Observational
Actual Enrollment : 1236 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Haemophilia, Experiences, Results and Opportunities (HERO): A Community-based Evaluation of the Psychosocial Effects of Haemophilia on Patients and Their Carers
Actual Study Start Date : June 3, 2011
Primary Completion Date : February 29, 2012
Study Completion Date : February 29, 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
A Other: No treatment given
No treatment given. Participants are to complete a questionnarie in the study.



Primary Outcome Measures :
  1. To quantify the extent of key psychosocial factors affecting patients with haemophilia in their daily lives [ Time Frame: After 6 weeks (recruitment and data collection) ]

Secondary Outcome Measures :
  1. To quantify how psychosocial factors are associated with treatment outcomes, compliance, health and general well-being [ Time Frame: After 6 weeks (recruitment and data collection) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult males with haemophilia and parents/carers of children with haemophilia.
Criteria

Inclusion Criteria:

  • Males with haemophilia A or B (with or without inhibitors)
  • Parents/carers of children aged below 18 years with haemophilia A or B (with or without inhibitors)
  • Patients currently receiving treatment for haemophilia with one of the following: replacement factor VIII or replacement factor IX or a bypassing agent (recombinant factor VIIa or aPCC (Activated prothrombin complex concentrate))
  • Patients with haemophilia, not currently receiving treatment with replacement factor VIII or IX or a bypassing agent (as appropriate), but who have had at least one spontaneous bleed into one or more joints within the last 12 months
  • Subjects must have access to the internet, either at home or at a location convenient to them, be able to complete a paper questionnaire, or be available to attend a face-to-face interview (Algerian subjects only), to participate in the survey

Exclusion Criteria:

  • Inability to understand and comply with written and verbal instructions unless assisted at the haemophilia treatment centre (HTC) or by a relative

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): NCT01322620


Locations
Canada
Novo Nordisk Investigational Site
Mississauga, Canada, L4W 4XI
Spain
Novo Nordisk Investigational Site
Madrid, Spain, 28033
United Kingdom
Novo Nordisk Investigational Site
Crawley, United Kingdom, RH11 9RT
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01322620     History of Changes
Other Study ID Numbers: F7HAEM-3911
U1111-1119-7128 ( Other Identifier: WHO )
First Posted: March 24, 2011    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases