Assessment of Cognitive Function, Fatigue and Health Related Quality of Life in Children With Beta Thalassemia

Quality of Life Clinical Trial

Official title:

Assessment of Cognitive Function, Fatigue and Health Related Quality of Life in Children With Beta Thalassemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05469230
• Other study ID #: P.T.REC/012/003783
• Status: Completed
• Start date: January 15, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: May 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

Inclusion Criteria:

• Beta thalassemia group (Study group): Both genders will be included and their age range from 8 to 16 years old

• Typically developed children (control group):

• Healthy children will be recruited from public governmental schools

• Healthy controls, matching the patients in age, gender and educational level.

• It will be ensured from their past medical history and clinical examination that they and their first-degree relatives never had any chronic disease, including thalassemia.

• Both genders will be included

• Their age range from 8 to 16 years old

Exclusion Criteria:

• Beta thalassemia group (study group): Any child Suffering from any other chronic diseases other than thalassemia

• Having visual or auditory problems

• Typically developed children (control group):

any child suffering from medical illness, musculoskeletal deformities, visual and auditory problems.

Related Conditions & MeSH terms

• Beta-Thalassemia
• Cognitive Change
• Fatigue
• Quality of Life
• Thalassemia

Locations

Country	Name	City	State
Egypt	Abo El-Rish Pediatric Hospital	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessing the change in cognitive function	assessing the change in verbal comprehension, perceptual reasoning, processing speed, working memory and total IQ using Wecshler Intelligence Scale for Children (4th edition)	baseline to 6 months
Primary	Assessing the change in fatigue	assessing the change in General Fatigue,Sleep/Rest Fatigue and Cognitive Fatigue using Pediatric quality of life inventory multidimensional fatigue scale (child report)	Baseline to 6 months
Primary	Assessing the change in health related quality of life	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)	Baseline to 6 months