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

NCT ID: NCT05469230

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 168 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-15
• Study Completion Date: 2023-05-30

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Esraa Elmorsi Abdelaziz Elderini Ibrahim

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esraa ibrahim, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Abo El-Rish Pediatric Hospital

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/003783

Identifier Type: -

Identifier Source: org_study_id