Clinical trial NCT05469230: Assessment of Cognitive Function, Fatigue and Health Related Quality of Life in Children With Beta Thalassemia
Official title: Assessment of Cognitive Function, Fatigue and Health Related Quality of Life in Children With Beta Thalassemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Change
Beta-Thalassemia
Fatigue
Quality of Life
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 168
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: * Children diagnosed with beta thalassemia will be recruited from Abo El-Rish Pediatric Hospital .(Cairo University Hospitals)
* Both genders will be included
* Their age range from 8 to 16 years old shouldn't have any associated diseases with beta thalassemia

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.

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.

Primary outcomes:
measure: assessing the change in cognitive function
timeFrame: baseline to 6 months
measure: Assessing the change in fatigue
timeFrame: Baseline to 6 months
measure: Assessing the change in health related quality of life
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Abo El-Rish Pediatric Hospital
Study officials:
affiliation: Cairo University
name: Esraa ibrahim, M.Sc
role: PRINCIPAL_INVESTIGATOR
References: