search
Back to results

Validation and Reliability of the CHO-KLAT in Turkish

Primary Purpose

Hemophilia A, Hemophilia B

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Evaluation of health related quality of life
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hemophilia A focused on measuring Hemophilia, Health Related Quality of life

Eligibility Criteria

4 Years - 18 Years (Child, Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • have Hemophilia A or B

Exclusion Criteria:

  • Did not have significant cognitive impairment

Sites / Locations

  • Adana Acibadem Hospital
  • Gaziantep UniversityRecruiting
  • Hasan Kalyoncu UniversityRecruiting
  • Van Yuzuncu Yıl UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Hemophilia

Arm Description

Evaluation of quality of life of children with hemophilia in Turkey

Outcomes

Primary Outcome Measures

HRQoL questionnaire
Health related quality of life

Secondary Outcome Measures

Full Information

First Posted
June 27, 2022
Last Updated
June 29, 2022
Sponsor
Yuzuncu Yıl University
Collaborators
Hasan Kalyoncu University, University of Gaziantep, Acıbadem Adana Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05439642
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University
Collaborators
Hasan Kalyoncu University, University of Gaziantep, Acıbadem Adana Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A, Hemophilia B
Keywords
Hemophilia, Health Related Quality of life

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Validation and reliability study
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hemophilia
Arm Type
Other
Arm Description
Evaluation of quality of life of children with hemophilia in Turkey
Intervention Type
Other
Intervention Name(s)
Evaluation of health related quality of life
Intervention Description
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
Primary Outcome Measure Information:
Title
HRQoL questionnaire
Description
Health related quality of life
Time Frame
1-2 week

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: have Hemophilia A or B Exclusion Criteria: Did not have significant cognitive impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayşe Merve M Tat, Asst.Prof
Phone
+905052431112
Email
amervetat@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Necati Muhammed Tat, Asst.Prof
Phone
+05075083347
Email
necatimuhammedtat@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayse Merve Tat, Asst.Prof
Organizational Affiliation
Van Yuzuncu Yıl University Faculty of Health Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tugba Badat Gonen, PhD
Organizational Affiliation
Hasan Kalyoncu University Faculty Of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmet Fayik Oner, Prof MD
Organizational Affiliation
Van Yuzuncu Yıl University Faculty of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Adana Acibadem Hospital
City
Adana
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bulent Antmen, Prof.MD
Phone
+05322348164
Email
bulent.antmen@acibadem.com
Facility Name
Gaziantep University
City
Gaziantep
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sinan Akbayram, Prof.MD
Phone
+905325968730
Email
drsinanakbayram@gmail.com
Facility Name
Hasan Kalyoncu University
City
Gaziantep
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tugba Badat Gonen
Phone
+05050905846
Email
tugba.badat@hku.edu.tr
Facility Name
Van Yuzuncu Yıl University
City
Van
ZIP/Postal Code
65100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayse Merve M Tat, Asst.Prof.
Phone
+905052431112
Email
amervetat@gmail.com
First Name & Middle Initial & Last Name & Degree
Necati Muhammed Tat, Asst.Prof.
Phone
+05075083347
Email
necatimuhammedtat@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Validation and Reliability of the CHO-KLAT in Turkish

We'll reach out to this number within 24 hrs