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Validation and Reliability of the CHO-KLAT in Turkish

Y

Yuzuncu Yıl University

Status

Enrolling

Conditions

Hemophilia B
Hemophilia A

Treatments

Other: Evaluation of health related quality of life

Study type

Interventional

Funder types

Other

Identifiers

NCT05439642
YuzuncuYıl2022/1

Details and patient eligibility

About

The aim of this study is to investigate the Turkish validity and reliability of the Canadian Haemophilia Outcomes-Kids' Life Assessment Tool version2.0. Patients aged 4-18 years with hemophilia a or b will be included in the study. The study was planned as a multicenter and it is aimed to reach 100 patients. The process included four steps: a linguistic adaptation, cognitive debriefing interviews with children and their parents, a validity assessment with the Pediatric Quality of Life Inventory (PedsQL) as a comparator, and a test retest reliability assessment.

Full description

Health-related quality of life assessment is considered an important outcome in the evaluation of children with hemophilia. The Canadian Haemophilia Outcomes-Kids' Life Assessment Tool version2.0 is a disease-specific health-related quality of life measurement tool for 4 to 18-year-old boys with haemophilia. The aim of this study is to ensure the use of CHO-KLAT in clinical studies in Turkey.

Methods: Patients aged 4-18 years with hemophilia a or b will be included in the study.The study will be carried out in Van, Gaziantep and Adana provinces in Turkey and and it is aimed to reach 100 patients with hemophilia. The process included four steps: a linguistic adaptation, cognitive debriefing interviews with children and their parents, a validity assessment with the Pediatric Quality of Life Inventory (PedsQL) as a comparator, and a test retest reliability assessment.

Enrollment

100 estimated patients

Sex

Male

Ages

4 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • have Hemophilia A or B

Exclusion criteria

  • Did not have significant cognitive impairment

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Hemophilia
Other group
Description:
Evaluation of quality of life of children with hemophilia in Turkey
Treatment:
Other: Evaluation of health related quality of life

Trial contacts and locations

4

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Central trial contact

Ayşe Merve M Tat, Asst.Prof; Necati Muhammed Tat, Asst.Prof

Data sourced from clinicaltrials.gov

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