To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives

Congenital Bleeding Disorder Clinical Trial

— HERO  

Official title:

Haemophilia, Experiences, Results and Opportunities (HERO) in Brazil: Assessment of Psychological Effects of Haemophilia on Patients and Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02241694
• Other study ID #: F7HAEM-4146
• Secondary ID: U1111-1147-4202
• Status: Completed
• Phase: N/A
• First received: September 1, 2014
• Last updated: July 9, 2015
• Start date: November 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Observational

Clinical Trial Summary

This survey is conducted in South America. The purpose is to identify the key psychosocial issues affecting patients with haemophilia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men aged 18 years or above with haemophilia A or B (with or without inhibitors) OR Parents/caregivers of children/adolescents younger than 18 years with haemophilia A or B (with or without inhibitors); only one subject per household will be able to participate

• Patients currently receiving one of the following treatments: a. replacement factor VIII therapy, b. replacement factor IX therapy, c. bypassing agents (recombinant factor VIIa or APCC) OR Patients with haemophilia, not receiving any kind of treatment with replacement factor VIII or IX or a bypassing agent (as appropriate), but who have had at least one spontaneous haemorrhage into one or more joints within the last 12 months

• The participants (patients with haemophilia and parents/caregivers for patients under 18 years old) must be able to complete a paper questionnaire in order to participate in the study

• Providing informed consent before the start of any study-related activities

Exclusion Criteria:

• Inability for the patients or parents/caregivers to understand and comply with verbal instructions, unless assisted by a member of the HTC (Haemophilia Treatment Center) or by a relative. (No other conditions were established for patients who cannot read or write to be able to participate in this study in addition to the need of help from a member of HTC or by a relative.)

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

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 questionnaire in the study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative assessments of perceived impact on daily life		Day 1	No
Secondary	Perceived disease control		Day 1	No
Secondary	Carrier status and reactions to haemophilia diagnosis		Day 1	No
Secondary	Genetic counselling and testing		Day 1	No
Secondary	Impact of haemophilia in siblings		Day 1	No
Secondary	Satisfaction with support from partners, family, friends, others		Day 1	No
Secondary	Sexual intimacy with partners in long-term relationships		Day 1	No
Secondary	Treatment method, compliance and location		Day 1	No
Secondary	Modified WHO-5 (World Health Organization-Five Well Being Index)		Day 1	No
Secondary	Knowledge and information about haemophilia		Day 1	No
Secondary	Improvements in haemophilia care		Day 1	No

External Links

•   Clinical Trials at Novo Nordisk