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

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors; Relatives to/Carers of Patients

Intervention: No treatment given (Other)

Phase: N/A

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Global Clinical Registry (GCR, 1452), GZZF, Study Director, Affiliation: Novo Nordisk A/S

Summary

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

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Cross-Sectional

Primary outcome: Qualitative assessments of perceived impact on daily life

Secondary outcome:

Perceived disease control

Carrier status and reactions to haemophilia diagnosis

Genetic counselling and testing

Impact of haemophilia in siblings

Satisfaction with support from partners, family, friends, others

Sexual intimacy with partners in long-term relationships

Treatment method, compliance and location

Modified WHO-5 (World Health Organization-Five Well Being Index)

Knowledge and information about haemophilia

Improvements in haemophilia care

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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.)

Locations and Contacts

Säo Paulo 05001-400, Brazil
Additional Information

Clinical Trials at Novo Nordisk

Starting date: November 2014
Last updated: July 9, 2015

Page last updated: August 20, 2015

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