Reliability and Validity of the Turkish Version of the PedHAL

NCT05889754 | Unknown

• 1 other identifier: 2023/53
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to establish the validity and reliability of the Turkish version of the Pediatric Haemophilia Activities List (short - PedHALshort) questionnaire.

Conditions

Hemophilia; Hemophilia A, Severe; Hemophilia B

Keywords

Functional independence; Activities of daily living; Hemophilia; Factor VIII; Factor IX

Outcome Measures

Primary Outcomes (2)

• Paediatric Haemophilia Activities List

  PedHAL contains 22 items in 7 areas: sitting/kneeling/standing, functions of legs, functions of arms, use of transportation, personal care, housework and leisure activities, and sports. It consists of a child version (8-17 years old) and a parent version (4-17 years old). Items are scored for each item on a 6-point Likert scale ("impossible", "always", "usually", "sometimes", "almost never", "never"), "not applicable (N/A)". . The score is converted to a normalized score from 0 to 100, the higher score representing better functional status. If more than half of the items are missing or scored as "not applicable" (N/A), a valid total score will not be calculated.

  through of the study, average 6 months

• FISH

  The scoring system, which is categorized according to the international classification of functionality, disability and health (ICF), has been prepared by considering the activities that hemophilia patients may be affected by in their daily lives. Being a performance-based scale allows it to be used in different languages. The scale consists of 8 questions in total, including the sub-parameters of self-care, transfer and locomotion. Self care subparameter; eating-hygiene, bathing and dressing, transfer sub-parameter; chair and squat, locomotion subparameter; It consists of walking, stair climbing (12-14 steps) and running activities. Scoring of the activities is between 1 and 4 according to the degree of independence. The minimum score that can be obtained from the scale is 8, and the maximum score is 32. A high score indicates the functional independence of the individual.

  through of the study, average 6 months

Study Arms (1)

Hemophilia Group

The PedHAL questionnaire will be administered to children aged 4-17 years with a diagnosis of hemophilia twice, one week apart. For construct validity assessment, the questionnaire will be compared with the Hemophilia Functional Independence Score (HJHS).

Eligibility Criteria

• Age: 4 Years - 17 Years
• Gender Eligibility Details: Hemophilia a disease is an X-linked recessive disease. Therefore, girls become carriers and do not show muscle joint problems.
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric group hemophilia A and hemophilia B children living in Gaziantep constitute the study population.

You may qualify if:

• Having been diagnosed with Hemophilia by a physician (Factor VIII-IX)
• Ages 4-17 years old
• Receiving regular prophylactic treatment
• Children who volunteered to participate in the study and whose family consent was given

You may not qualify if:

• \- Children with neurological signs that limit activities of daily living

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Şahinbey, 27100, Turkey (Türkiye)

Location

Related Publications (7)

• Souza JC, Simoes HG, Campbell CS, Pontes FL, Boullosa DA, Prestes J. Haemophilia and exercise. Int J Sports Med. 2012 Feb;33(2):83-8. doi: 10.1055/s-0031-1286292. Epub 2011 Nov 17.

  PMID: 22095329 BACKGROUND

• Wagner B, Kruger S, Hilberg T, Ay C, Hasenoehrl T, Huber DF, Crevenna R. The effect of resistance exercise on strength and safety outcome for people with haemophilia: A systematic review. Haemophilia. 2020 Mar;26(2):200-215. doi: 10.1111/hae.13938. Epub 2020 Feb 24.

  PMID: 32091659 BACKGROUND

• Schafer GS, Valderramas S, Gomes AR, Budib MB, Wolff AL, Ramos AA. Physical exercise, pain and musculoskeletal function in patients with haemophilia: a systematic review. Haemophilia. 2016 May;22(3):e119-29. doi: 10.1111/hae.12909. Epub 2016 Apr 14.

  PMID: 27075748 BACKGROUND

• De la Corte-Rodriguez H, Rodriguez-Merchan EC. The role of physical medicine and rehabilitation in haemophiliac patients. Blood Coagul Fibrinolysis. 2013 Jan;24(1):1-9. doi: 10.1097/MBC.0b013e32835a72f3.

  PMID: 23103725 BACKGROUND

• Young NL, Bradley CS, Blanchette V, Wakefield CD, Barnard D, Wu JK, McCusker PJ. Development of a health-related quality of life measure for boys with haemophilia: the Canadian Haemophilia Outcomes--Kids Life Assessment Tool (CHO-KLAT). Haemophilia. 2004 Mar;10 Suppl 1:34-43. doi: 10.1111/j.1355-0691.2004.00877.x.

  PMID: 14987247 BACKGROUND

• Timmer MA, Gouw SC, Feldman BM, Zwagemaker A, de Kleijn P, Pisters MF, Schutgens REG, Blanchette V, Srivastava A, David JA, Fischer K, van der Net J. Measuring activities and participation in persons with haemophilia: A systematic review of commonly used instruments. Haemophilia. 2018 Mar;24(2):e33-e49. doi: 10.1111/hae.13367. Epub 2017 Nov 27.

  PMID: 29178149 BACKGROUND

• Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979 Mar;86(2):420-8. doi: 10.1037//0033-2909.86.2.420.

  PMID: 18839484 BACKGROUND

MeSH Terms

Conditions

Hemophilia A; Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Central Study Contacts

Tuğba GÖNEN, Asst. Prof.

CONTACT

05050905846; tugba.badat@hku.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 5, 2023
• Study Start: May 30, 2023
• Primary Completion: August 30, 2023
• Study Completion: December 30, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)