Validation and Reliability of the CHO-KLAT in Turkish

June 29, 2022 updated by: Ayse Merve TAT, Yuzuncu Yıl University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Adana, Turkey
        • Not yet recruiting
        • Adana Acibadem Hospital
        • Contact:
      • Gaziantep, Turkey
        • Recruiting
        • Hasan Kalyoncu University
        • Contact:
      • Gaziantep, Turkey
        • Recruiting
        • Gaziantep University
        • Contact:
      • Van, Turkey, 65100
        • Recruiting
        • Van Yuzuncu Yıl University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • have Hemophilia A or B

Exclusion Criteria:

  • Did not have significant cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Hemophilia
Evaluation of quality of life of children with hemophilia in Turkey
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HRQoL questionnaire
Time Frame: 1-2 week
Health related quality of life
1-2 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yıl University

Collaborators

Hasan Kalyoncu University
University of Gaziantep
Acıbadem Adana Hospital

Investigators

  • Study Director: Ayse Merve Tat, Asst.Prof, Van Yüzüncü Yıl University Faculty of Health Sciences
  • Principal Investigator: Tugba Badat Gonen, PhD, Hasan Kalyoncu University Faculty of Health Sciences
  • Study Chair: Ahmet Fayik Oner, Prof MD, Van Yuzuncu Yıl University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2022

Primary Completion (ANTICIPATED)

September 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

June 27, 2022

First Submitted That Met QC Criteria

June 29, 2022

First Posted (ACTUAL)

June 30, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 29, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YuzuncuYıl2022/1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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