Hemophilia ANCT05439642
Validation and Reliability of the CHO-KLAT in Turkish
A study testing Evaluation of health related quality of life in people with Hemophilia A and Hemophilia B, run by Yuzuncu Yil University at 4 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years, men only
- Conditions the study is for
- Hemophilia A, Hemophilia B
- What is being tested?
- Evaluation of health related quality of life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- have Hemophilia A or B
Who cannot join
- Did not have significant cognitive impairment
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites, 4 recruiting
- Not yet recruiting
Adana Acibadem Hospital
Adana
Bulent Antmen, Prof.MD, +05322348164, bulent.antmen@acibadem.com
- Recruiting
Gaziantep University
Gaziantep
Sinan Akbayram, Prof.MD, +905325968730, drsinanakbayram@gmail.com
- Recruiting
Hasan Kalyoncu University
Gaziantep
Tugba Badat Gonen, +05050905846, tugba.badat@hku.edu.tr
- Recruiting
Van Yuzuncu Yıl University
Van, 65100
Ayse Merve M Tat, Asst.Prof., +905052431112, amervetat@gmail.com
Necati Muhammed Tat, Asst.Prof., +05075083347, necatimuhammedtat@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemophilia A, Hemophilia B
- Being tested
- Evaluation of health related quality of life
- Keywords
- Hemophilia, Health Related Quality of life
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of health related quality of lifeOther
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
| Study group | Role | What they receive |
|---|---|---|
| Hemophilia | Other | Evaluation of quality of life of children with hemophilia in Turkey Receives: Other: Evaluation of health related quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRQoL questionnaire
Health related quality of life
Measured: 1-2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Jun 2022
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Validation and reliability study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Collaborators
- Hasan Kalyoncu University, University of Gaziantep, Acıbadem Adana Hospital
- Responsible party
- Principal investigator, Ayse Merve TAT, Yuzuncu Yil University
- Investigators
- Ayse Merve Tat, Asst.Prof, Study director, Van Yuzuncu Yıl University Faculty of Health SciencesTugba Badat Gonen, PhD, Principal investigator, Hasan Kalyoncu University Faculty Of Health SciencesAhmet Fayik Oner, Prof MD, Study chair, Van Yuzuncu Yıl University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439642
- Sponsor's protocol ID
- YuzuncuYıl2022/1
- Status last verified
- Jun 2022
- First submitted
- 27 Jun 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Reliability of the Canadian Haemophilia Outcomes-Kids' Life Assessment Tool (CHO-KLAT) in Turkish
- ClinicalTrials.gov ID
- NCT05439642
- Acronym / sponsor ID
- YuzuncuYıl2022/1
- Conditions
- Hemophilia A, Hemophilia B
- Keywords
- Hemophilia, Health Related Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Collaborators
- Hasan Kalyoncu University, University of Gaziantep, Acıbadem Adana Hospital
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Validation and reliability study
| Arm | Type | Receives |
|---|---|---|
| Hemophilia | Other | Other: Evaluation of health related quality of lifeEvaluation of quality of life of children with hemophilia in Turkey |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- have Hemophilia A or B
Key exclusion criteria (1 listed)
- Did not have significant cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of health related quality of lifeEvaluation 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 | Other | Hemophilia |
Primary outcome
HRQoL questionnaire
Time frame: 1-2 week
Health related quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayse Merve Tat, Asst.Prof study director
Van Yuzuncu Yıl University Faculty of Health Sciences
Tugba Badat Gonen, PhD principal investigator
Hasan Kalyoncu University Faculty Of Health Sciences
Ahmet Fayik Oner, Prof MD study chair
Van Yuzuncu Yıl University Faculty of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of health related quality of life in people with Hemophilia A and Hemophilia B, run by Yuzuncu Yil University at 4 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Merve M Tat, Asst.Prof (+905052431112, amervetat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRQoL questionnaire (time frame: 1-2 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.