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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01322620
First received: March 23, 2011
Last updated: February 20, 2017
Last verified: February 2017

March 23, 2011
February 20, 2017
June 3, 2011
February 29, 2012   (Final data collection date for primary outcome measure)
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) ]
Same as current
Complete list of historical versions of study NCT01322620 on ClinicalTrials.gov Archive Site
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) ]
Same as current
Not Provided
Not Provided
 
Survey Evaluating the Psychosocial Effects of Living With Haemophilia
Haemophilia, Experiences, Results and Opportunities (HERO): A Community-based Evaluation of the Psychosocial Effects of Haemophilia on Patients and Their Carers

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample
Adult males with haemophilia and parents/carers of children with haemophilia.
  • Congenital Bleeding Disorder
  • Haemophilia A
  • Haemophilia B
  • Haemophilia A With Inhibitors
  • Haemophilia B With Inhibitors
  • Relatives to/Carers of Patients
Other: No treatment given
No treatment given. Participants are to complete a questionnarie in the study.
A
Intervention: Other: No treatment given

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1236
February 29, 2012
February 29, 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Spain,   United Kingdom
Algeria,   Argentina,   Brazil,   China,   France,   Germany,   Italy,   Japan,   United States
 
NCT01322620
F7HAEM-3911
U1111-1119-7128 ( Other Identifier: WHO )
No
Not Provided
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP