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Validation and Reliability of the CHO-KLAT in Turkish

NCT ID: NCT05439642

Last Updated: 2022-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2022-12-01

Brief Summary

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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

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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.

Conditions

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Hemophilia A Hemophilia B

Keywords

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Hemophilia Health Related Quality of life

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Validation and reliability study
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Hemophilia

Evaluation of quality of life of children with hemophilia in Turkey

Group Type OTHER

Evaluation of health related quality of life

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* have Hemophilia A or B

Exclusion Criteria

* Did not have significant cognitive impairment
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hasan Kalyoncu University

OTHER

Sponsor Role collaborator

University of Gaziantep

OTHER

Sponsor Role collaborator

Acıbadem Adana Hospital

OTHER

Sponsor Role collaborator

Yuzuncu Yıl University

OTHER

Sponsor Role lead

Responsible Party

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Ayse Merve TAT

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayse Merve Tat, Asst.Prof

Role: STUDY_DIRECTOR

Van Yuzuncu Yıl University Faculty of Health Sciences

Tugba Badat Gonen, PhD

Role: PRINCIPAL_INVESTIGATOR

Hasan Kalyoncu University Faculty Of Health Sciences

Ahmet Fayik Oner, Prof MD

Role: STUDY_CHAIR

Van Yuzuncu Yıl University Faculty of Medicine

Locations

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Adana Acibadem Hospital

Adana, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Gaziantep University

Gaziantep, , Turkey (Türkiye)

Site Status RECRUITING

Hasan Kalyoncu University

Gaziantep, , Turkey (Türkiye)

Site Status RECRUITING

Van Yuzuncu Yıl University

Van, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ayşe Merve M Tat, Asst.Prof

Role: CONTACT

Phone: +905052431112

Email: [email protected]

Necati Muhammed Tat, Asst.Prof

Role: CONTACT

Phone: +05075083347

Email: [email protected]

Facility Contacts

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Bulent Antmen, Prof.MD

Role: primary

Sinan Akbayram, Prof.MD

Role: primary

Tugba Badat Gonen

Role: primary

Ayse Merve M Tat, Asst.Prof.

Role: primary

Necati Muhammed Tat, Asst.Prof.

Role: backup

Other Identifiers

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YuzuncuYıl2022/1

Identifier Type: -

Identifier Source: org_study_id