Assessment of Cognitive Function and Quality of Life in Thalassemic Children at Sohag University Hospital

NCT06058260 | Unknown

• 1 other identifier: Soh-Med-23-09-07MS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Thalassemia syndromes are a heterogeneous group of single gene disorders, inherited in an autosomal recessive manner ,prevalent among all ethnic groups and in almost every country around the world . Once a child has been diagnosed as thalassemia, he has to take lifelong treatment , where cure is not attainable and treatment may be prolonged . It is a life-threatening and life-limiting condition that affects the patient clinically and psychologically, so Health-related Quality of Life (HRQOL) is likely to be an essential outcome for these patients. Quality of life in thalassemic children such as : Repeated visits to hospitals for regular blood transfusion, cost of chelation therapy, repeated laboratory tests for monitoring therapy and for early detection of any complications. also life-long costly therapy along with poor quality of life will have adverse impact on the family. A better understanding of the factors associated with HRQOL among children with thalassemia could have a direct effect on the development of more suitable clinical, counselling and social support programs to enhance treatment outcomes. Cognitive dysfunction was Reported either due to the disease or its treatment ,frequent school absences, frequent hospitalizations, and physical and social restrictions lead to cognitive dysfunction . This neurological involvement in thalassemic children is primarily silent, with subclinical manifestations that can only be detected by cognitive assessment tests.

Conditions

Thalassemia

Outcome Measures

Primary Outcomes (2)

• The Stanford-Binet Intelligence Scale fifth edition

  Assessment of Cognitive Function Minimum Value is 40 Maximum value is 160 Higher scores mean a better outcome

  12 months

• Pediatric Quality of Life Inventory

  Assessment of Quality of Life Minimum value is 0 Maximum value is 100 Higher scores mean a better outcome

  12 months

Study Arms (2)

Children With Thalassemia (Cases)

Hematological Disease which are a heterogeneous group of single gene disorders, inherited in an autosomal recessive manner ( Thalassemia Syndrome )

Other: Pediatric Quality of Life Inventory (questionnaire) and The Stanford-Binet Intelligence Scale fifth edition

Healthy Children ( Controls )

Healthy Children free from any chronic illness

Other: Pediatric Quality of Life Inventory (questionnaire) and The Stanford-Binet Intelligence Scale fifth edition

Interventions

Pediatric Quality of Life Inventory (questionnaire) and The Stanford-Binet Intelligence Scale fifth edition OTHER

Quality of Life Assessment By Pediatric Quality of life Inventory. Cognitive Function Assessment By The Stanford-Binet Intelligence Scale fifth edition.

Children With Thalassemia (Cases); Healthy Children ( Controls )

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All the diagnosed thalassemic children age between 4 and 18 years.

You may qualify if:

• All the diagnosed thalassemic children age between 4 and 18 years.

You may not qualify if:

• Any other hematological disease.
• Age less than 4 years and more than 18 years.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university Hospital

Sohag, Sohag, Egypt

Location

Related Publications (1)

• Choudhry VP. Thalassemia Minor and Major: Current Management. Indian J Pediatr. 2017 Aug;84(8):607-611. doi: 10.1007/s12098-017-2325-1. Epub 2017 Apr 24.

  PMID: 28435994 BACKGROUND

MeSH Terms

Conditions

Thalassemia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Mena G Shawky, resident

CONTACT

01289496538; Menagergeos@med.sohag.edu.eg

Alzahraa A Ahmed, professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident-pediatric department-sohag hospital university

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 28, 2023
• Study Start: October 20, 2023
• Primary Completion: October 20, 2024
• Study Completion: October 20, 2024
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

EG (1)