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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05469230
Recruitment Status : Recruiting
First Posted : July 21, 2022
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
Esraa Elmorsi Abdelaziz Elderini Ibrahim, Cairo University

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Cognitive Change Beta-Thalassemia Fatigue Quality of Life

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue Thalassemia

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Esraa Ibrahim, M.Sc 01011267858 esraa.elmorsi@pt.cu.edu.eg

Locations
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Egypt
Abo El-Rish Pediatric Hospital Recruiting
Giza, Egypt
Contact: Esraa Ibrahim, M.Sc    01011267858    esraa.elmorsi@pt.cu.edu.eg   
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Esraa ibrahim, M.Sc Cairo University
More Information
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Responsible Party: Esraa Elmorsi Abdelaziz Elderini Ibrahim, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT05469230    
Other Study ID Numbers: P.T.REC/012/003783
First Posted: July 21, 2022    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Fatigue
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn