Clinical trial NCT05439642: Validation and Reliability of the CHO-KLAT in Turkish
Official title: Validation and Reliability of the Canadian Haemophilia Outcomes-Kids' Life Assessment Tool (CHO-KLAT) in Turkish
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemophilia A
Hemophilia B
Keywords: Hemophilia
Health Related Quality of life
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
Collaborators: name: Hasan Kalyoncu University
name: University of Gaziantep
name: Acıbadem Adana Hospital
First posted: 2022-06-30
Enrollment: 100
Sex: MALE
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Validation and reliability study
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* have Hemophilia A or B

Exclusion Criteria:

* Did not have significant cognitive impairment

Primary outcomes:
measure: HRQoL questionnaire
timeFrame: 1-2 week
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Adana Acibadem Hospital
city: Gaziantep
country: Turkey
facility: Gaziantep University
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
city: Van
country: Turkey
facility: Van Yuzuncu Yıl University
Study officials:
affiliation: Van Yuzuncu Yıl University Faculty of Health Sciences
name: Ayse Merve Tat, Asst.Prof
role: STUDY_DIRECTOR
affiliation: Hasan Kalyoncu University Faculty Of Health Sciences
name: Tugba Badat Gonen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Van Yuzuncu Yıl University Faculty of Medicine
name: Ahmet Fayik Oner, Prof MD
role: STUDY_CHAIR
References: