Clinical trial NCT02241694: To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives
Official title: Haemophilia, Experiences, Results and Opportunities (HERO) in Brazil: Assessment of Psychological Effects of Haemophilia on Patients and Caregivers
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: 2014-09-16
Enrollment: 200
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 survey is conducted in South America. The purpose is to identify the key psychosocial issues affecting patients with haemophilia.


Eligibility criteria: 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.)

Primary outcomes:
measure: Qualitative assessments of perceived impact on daily life
timeFrame: Day 1
Secondary outcomes:
measure: Perceived disease control
timeFrame: Day 1
measure: Carrier status and reactions to haemophilia diagnosis
timeFrame: Day 1
measure: Genetic counselling and testing
timeFrame: Day 1
measure: Impact of haemophilia in siblings
timeFrame: Day 1
measure: Satisfaction with support from partners, family, friends, others
timeFrame: Day 1
measure: Sexual intimacy with partners in long-term relationships
timeFrame: Day 1
measure: Treatment method, compliance and location
timeFrame: Day 1
measure: Modified WHO-5 (World Health Organization-Five Well Being Index)
timeFrame: Day 1
measure: Knowledge and information about haemophilia
timeFrame: Day 1
measure: Improvements in haemophilia care
timeFrame: Day 1
Other outcomes:
Locations:
city: Säo Paulo
country: Brazil
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452), GZZF
role: STUDY_DIRECTOR
References: