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

NCT02241694 | Completed

• 2 other identifiers: F7HAEM-4146U1111-1147-4202
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Congenital Bleeding Disorder; Haemophilia A; Haemophilia B; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors; Relatives to/Carers of Patients

Outcome Measures

Primary Outcomes (1)

• Qualitative assessments of perceived impact on daily life

  Day 1

Secondary Outcomes (10)

• Perceived disease control

  Day 1

• Carrier status and reactions to haemophilia diagnosis

  Day 1

• Genetic counselling and testing

  Day 1

• Impact of haemophilia in siblings

  Day 1

• Satisfaction with support from partners, family, friends, others

  Day 1

Study Arms (1)

survey

Other: No treatment given

Interventions

No treatment given OTHER

No treatment given. Participants are to complete a questionnaire in the study.

survey

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult males with haemophilia and parents/carers of children with haemophilia.

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Säo Paulo, 05001-400, Brazil

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Hemophilia A; Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Study Officials

• Global Clinical Registry (GCR, 1452), GZZF

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2014
• First Posted: September 16, 2014
• Study Start: November 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 10, 2015

Record last verified: 2015-07

Locations

BR (1)