NCT05439642

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

June 27, 2022

Last Update Submit

June 29, 2022

Conditions

Keywords

HemophiliaHealth Related Quality of life

Outcome Measures

Primary Outcomes (1)

  • HRQoL questionnaire

    Health related quality of life

    1-2 week

Study Arms (1)

Hemophilia

OTHER

Evaluation of quality of life of children with hemophilia in Turkey

Other: Evaluation of health related quality of life

Interventions

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

Hemophilia

Eligibility Criteria

Age4 Years - 18 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • have Hemophilia A or B

You may not qualify if:

  • Did not have significant cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Adana Acibadem Hospital

Adana, Turkey (Türkiye)

NOT YET RECRUITING

Gaziantep University

Gaziantep, Turkey (Türkiye)

RECRUITING

Hasan Kalyoncu University

Gaziantep, Turkey (Türkiye)

RECRUITING

Van Yuzuncu Yıl University

Van, 65100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hemophilia AHemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Study Officials

  • Ayse Merve Tat, Asst.Prof

    Van Yuzuncu Yıl University Faculty of Health Sciences

    STUDY DIRECTOR
  • Tugba Badat Gonen, PhD

    Hasan Kalyoncu University Faculty Of Health Sciences

    PRINCIPAL INVESTIGATOR
  • Ahmet Fayik Oner, Prof MD

    Van Yuzuncu Yıl University Faculty of Medicine

    STUDY CHAIR

Central Study Contacts

Ayşe Merve M Tat, Asst.Prof

CONTACT

Necati Muhammed Tat, Asst.Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Validation and reliability study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 27, 2022

First Posted

June 30, 2022

Study Start

June 1, 2022

Primary Completion

September 1, 2022

Study Completion

December 1, 2022

Last Updated

June 30, 2022

Record last verified: 2022-06

Locations