Survey Evaluating the Psychosocial Effects of Living With Haemophilia

Congenital Bleeding Disorder Clinical Trial

— HERO  

Official title:

Haemophilia, Experiences, Results and Opportunities (HERO): A Community-based Evaluation of the Psychosocial Effects of Haemophilia on Patients and Their Carers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322620
• Other study ID #: F7HAEM-3911
• Secondary ID: U1111-1119-7128
• Status: Completed
• Phase: N/A
• First received: March 23, 2011
• Last updated: February 20, 2017
• Start date: June 3, 2011
• Est. completion date: February 29, 2012

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1236
• Est. completion date: February 29, 2012
• Est. primary completion date: February 29, 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A
• Haemophilia A With Inhibitors
• Haemophilia B
• Haemophilia B With Inhibitors
• Hemophilia A
• Hemophilia B
• Hemostatic Disorders
• Relatives to/Carers of Patients

Intervention

Other:
• No treatment given
No treatment given. Participants are to complete a questionnarie in the study.

Locations

Country	Name	City	State
Canada	Novo Nordisk Investigational Site	Mississauga
Spain	Novo Nordisk Investigational Site	Madrid
United Kingdom	Novo Nordisk Investigational Site	Crawley

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Canada,  Spain,  United Kingdom, 

References & Publications (2)

Forsyth AL, Gregory M, Nugent D, Garrido C, Pilgaard T, Cooper DL, Iorio A. Haemophilia Experiences, Results and Opportunities (HERO) Study: survey methodology and population demographics. Haemophilia. 2014 Jan;20(1):44-51. doi: 10.1111/hae.12239. — View Citation

Witkop M, Guelcher C, Forsyth A, Hawk S, Curtis R, Kelley L, Frick N, Rice M, Rosu G, Cooper DL. Treatment outcomes, quality of life, and impact of hemophilia on young adults (aged 18-30 years) with hemophilia. Am J Hematol. 2015 Dec;90 Suppl 2:S3-10. doi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To quantify the extent of key psychosocial factors affecting patients with haemophilia in their daily lives		After 6 weeks (recruitment and data collection)
Secondary	To quantify how psychosocial factors are associated with treatment outcomes, compliance, health and general well-being		After 6 weeks (recruitment and data collection)

External Links

•   Clinical Trials at Novo Nordisk