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: March 6, 2013
Last verified: March 2013
  Purpose

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 Intervention
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
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 1236
Study Start Date: June 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Other: No treatment given
No treatment given. Participants are to complete a questionnarie in the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322620

Locations
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, United States, 08540
Algeria
Algiers, Algeria, 16035
Argentina
Prov. de Buenos Aires, Argentina, B1636DSU
Canada
Mississauga, Canada, L4W 4XI
China, Beijing
Beijing, Beijing, China, 100004
France
Paris La défense cedex, France, 92932
Germany
Mainz, Germany, 55127
Italy
Rome, Italy, 00144
Spain
Madrid, Spain, 28033
United Kingdom
Crawley, United Kingdom, RH11 9RT
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Trine Pilgaard Novo Nordisk A/S
Study Director: Birgitte Toftemose Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01322620     History of Changes
Other Study ID Numbers: F7HAEM-3911, U1111-1119-7128
Study First Received: March 23, 2011
Last Updated: March 6, 2013
Health Authority: Algeria: Not required for observational study
Argentina: Not required for observational study
Brazil: Not required for observational study
Canada: Not required for observational study
China: Not required for observational study
France: Not required for observational study
Germany: Not required for observational study
Italy: Not required for observational study
Spain: Not required for observational study
United Kingdom: Not required for observational study
United States: Not required for observational study

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

ClinicalTrials.gov processed this record on October 20, 2014