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临床试验/NCT05439642
NCT05439642Unknown不适用

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

Yuzuncu Yıl University5 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
5
主要终点
HRQoL questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • have Hemophilia A or B

排除标准

  • Did not have significant cognitive impairment

结局指标

主要结局

HRQoL questionnaire

时间窗: 1-2 week

Health related quality of life

次要结局

未报告次要终点

研究者

发起方
Yuzuncu Yıl University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayse Merve TAT

Assistant Professor

Yuzuncu Yıl University

研究点 (5)

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