Assessment of Cognitive Function, Fatigue and Health Related Quality of Life in Children With Beta Thalassemia
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|ClinicalTrials.gov Identifier: NCT05469230|
Recruitment Status : Recruiting
First Posted : July 21, 2022
Last Update Posted : July 22, 2022
This study aims to:
- Assess the cognitive function in children with beta thalassemia
- Evaluate the fatigue in beta thalassemic children
- Assess the health related quality of life measures in children with beta thalassemia.
|Condition or disease|
|Cognitive Change Beta-Thalassemia Fatigue Quality of Life|
The cognitive abilities are extremely important for academic achievement. Despite their importance, the evaluation of cognitive function is rarely performed for thalassemia patients. So it is important to assess it and should be a routine comprehensive care of beta thalassemia patients to detect cases that suffer from verbal and performance dysfunction and subject them to the learning skills programs, so investigators can monitor any defects or problems that could arise early.
Thalassemia not only affect cognitive abilities, it has also many negative effects on physical health; the patients cannot perform activities easily, get fatigued easily and quickly. Also, emotional and social health aspects are affected. So, assessing health related quality of life is recognized as an indispensable indicator for a general evaluation of patients with thalassemia through which valuable evidence could be provided to improve treatments and to make effective decisions.
Cognitive function, fatigue and health related quality of life in children with beta thalassemia will be assessed by using valid and reliable scales. All the patients and controls will be subjected to assessment using the Arabic version of the Wechsler Intelligence Scale for Children which assess cognitive function and provide the output of the Verbal comprehension index ,Perceptual reasoning index, processing speed index, working memory index and a combined Full-Scale IQ test. The assessment included 15 subtests.
Health related quality of life will be assessed using the Arabic version of child proxy report of the Pediatric Quality of Life Inventory Generic Core Scale (version 4)( PedsQL). The PedsQL Inventory Generic Core Scales is a brief 23 items multidimensional instrument assessing the physical, emotional, social and school functioning domains. It is a reliable and valid tool designed to measure Health related quality of life The fatigue will be assessed using the Arabic version of child report of the Pediatric Quality of Life Inventory Multidimensional Fatigue Scale which covers three domains, including General Fatigue (6 items), Sleep/Rest Fatigue (6 items) and Cognitive Fatigue (6 items) .
Every child will be evaluated alone in spacious and quiet room free from any visual and auditory distractions.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Assessment of Cognitive Function, Fatigue and Health Related Quality of Life in Children With Beta Thalassemia|
|Actual Study Start Date :||January 15, 2022|
|Estimated Primary Completion Date :||August 1, 2022|
|Estimated Study Completion Date :||December 30, 2022|
Typically developed children group
Typically developed children will be from both genders. the age range will be (8-16) years old and will be recruited from public governmental schools
Beta thalassemia group
children diagnosed with beta thalassemia major and intermedia will be recruited from Abo-El-Rish Pediatric Hospital. the age will be (8-16) years and will be from both genders
- assessing the change in cognitive function [ Time Frame: baseline to 6 months ]assessing the change in verbal comprehension, perceptual reasoning, processing speed, working memory and total IQ using Wecshler Intelligence Scale for Children (4th edition)
- Assessing the change in fatigue [ Time Frame: Baseline to 6 months ]assessing the change in General Fatigue,Sleep/Rest Fatigue and Cognitive Fatigue using Pediatric quality of life inventory multidimensional fatigue scale (child report)
- Assessing the change in health related quality of life [ Time Frame: Baseline to 6 months ]assessing the change in physical, emotional, social and school functioning domains using the Pediatric quality of life inventory Generic core scale (child report) (version 4)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05469230
|Contact: Esraa Ibrahim, M.Scemail@example.com|
|Abo El-Rish Pediatric Hospital||Recruiting|
|Contact: Esraa Ibrahim, M.Sc 01011267858 firstname.lastname@example.org|
|Principal Investigator:||Esraa ibrahim, M.Sc||Cairo University|