Quality of Life in Adult Patients With Severe Haemophilia in Turkey

Haemophilia Clinical Trial

— TurkHaemQoL  

Official title:

A Nationwide Multicenter Study on the Quality of Life in Adult Patients With Severe Haemophilia in Turkey

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01623960
• Other study ID #: THD-HAEM-QoL
• Status: Not yet recruiting
• Phase: N/A
• First received: June 17, 2012
• Last updated: June 17, 2012
• Start date: October 2012
• Est. completion date: February 2014

Study information

• Verified date: June 2012
• Source: Turkish Society of Hematology
• Contact: M.Cem Ar, MD, PhD
• Phone: +905326818890
• Email: mcemar68[@]yahoo.com
• Is FDA regulated: No
• Health authority: Turkey: Turkish Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

The primary aim of this study is to evaluate the overall quality of life in adult patients with severe haemophilia (an inherited bleeding disorder affecting mainly men) in Turkey and to assess the impact of certain disease and drug related factors (treatment modality, presence of viral disease, inhibitor, etc.) on the quality of life.

Description:

Haemophilia is an inherited bleeding disorder affecting one in 10000 male births worldwide. People with severe haemophilia usually suffer from recurrent life threatening bleeds (e.g. into the brain, digestive system or abdomen) and/or disabling degenerative disease of weight bearing joints (e.g. knees, elbows and ankles)resulting from haemorrhage into the joints. Daily activities of people with haemophilia has been shown to be dramatically hampered by the resultant joint damage. Evaluation of quality of life issues in people with severe haemophilia would help to create awareness of their problems and limitations. This would also set up the scene for developing policies to improve the treatment options/facilities and social life of the patients. Current study aims to assess the quality of life of adult patients with severe haemophilia in a developing country (Turkey) by using a validated Quality of Life Questionnaire (Turkish version of Haem-A-QoL).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: February 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age equal or greater than 18 years

• male gender

• factor VIII or IX level equal or below 1%

• patients that are willing to participate and have given a written consent

Exclusion Criteria:

• age less than 18 years

• females

• factor levels above 1%

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Haemophilia
• Hemophilia A

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Turkish Society of Hematology