Clinical trial NCT01322620: Survey Evaluating the Psychosocial Effects of Living With Haemophilia
Official title: Haemophilia, Experiences, Results and Opportunities (HERO): A Community-based Evaluation of the Psychosocial Effects of Haemophilia on Patients and Their Carers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Bleeding Disorder
Haemophilia A
Haemophilia B
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Relatives to/Carers of Patients
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-03-24
Enrollment: 1236
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult males with haemophilia and parents/carers of children with haemophilia.

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.


Eligibility 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

Primary outcomes:
measure: To quantify the extent of key psychosocial factors affecting patients with haemophilia in their daily lives
timeFrame: After 6 weeks (recruitment and data collection)
Secondary outcomes:
measure: To quantify how psychosocial factors are associated with treatment outcomes, compliance, health and general well-being
timeFrame: After 6 weeks (recruitment and data collection)
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Crawley
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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. Epub 2013 Aug 1.
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: 10.1002/ajh.24220.