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NCT05439642 Clinical Trial

Validation and Reliability of the CHO-KLAT in Turkish

Hemophilia A Clinical Trial

Official title:
Validation and Reliability of the Canadian Haemophilia Outcomes-Kids' Life Assessment Tool (CHO-KLAT) in Turkish

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05439642
Other study ID # YuzuncuYil2022/1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date December 1, 2022

Study information
Verified date June 2022
Source Yuzuncu Yil University
Contact Ayse Merve M Tat, Asst.Prof
Phone +905052431112
Email amervetat@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender Male
Age group 4 Years to 18 Years
Eligibility Inclusion Criteria: - have Hemophilia A or B Exclusion Criteria: - Did not have significant cognitive impairment

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Evaluation of health related quality of life
Evaluation of health related quality of life of boys with hemophilia with the Canadian Haemophilia Outcomes-Kids' Life Assessment Tool and the Pediatric Inventory of Quality of Life

Locations
Country Name City State
Turkey Adana Acibadem Hospital Adana
Turkey Gaziantep University Gaziantep
Turkey Hasan Kalyoncu University Gaziantep
Turkey Van Yuzuncu Yil University Van

Sponsors (4)
Lead Sponsor Collaborator
Yuzuncu Yil University Acibadem Adana Hospital, Hasan Kalyoncu University, University of Gaziantep

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary HRQoL questionnaire Health related quality of life 1-2 week
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