Clinical trial NCT05105659: Assessment of Cognitive Functions, Psychological Symptoms, and Quality of Life Among B Thalassemia Patients and Their Clinical Correlates.
Official title: Assessment of Cognitive Functions, Psychological Symptoms, and Quality of Life Among B Thalassemia Patients and Their Clinical Correlates.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: B Thalassemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Study subjects: will include three groups: Thalassemia major patients group, Thalassemia intermediate patients group, and healthy control group they will be age and sex matched.

Brief summary: Multiple studies showed the negative impact thalassemia disease and its therapy have on the cognition of these patients. This study aims to assess and compare the cognition, psychological impact and quality of life among patients with B thalassemia major, requiring regular blood transfusion, patients with B thalassemia intermedia, who don't, and healthy controls. Thus, estimating the role of blood transfusion and hemosiderosis in cognitive impairment, psychological symptoms, and low quality of life in these patients.

Detailed description: Thalassemia is one the most common autosomal recessive haemolytic diseases both worldwide and in the middle east. (1) Beta-thalassemia is a disorder characterized by the congenital absence of the beta chain synthesis of the haemoglobin tetramer, In healthy individuals the haemoglobin chain consists of 2 alpha and 2 beta globin chains, as a result the absence of 2 beta chains in the b thalassemia patients results in clinical symptoms as pallor and failure to thrive. (2,3,4) These patients thus rely on blood transfusions for their entire lives, unless they undergo bone marrow transplant, exposing them to many complications both organically and psychologically. (5) Other patients with b thalassemia whose anaemia doesn't require regular blood transfusion are considered to have B thalassemia intermediate. (6)B thalassemia is among one the most common haemoglobinopathies in Egypt, estimating t 1000/ 1.5 million per year live births born with thalassemia disease. (7) Attention, orientation, memory, gnosis, and executive functions are among some of the cognitive functions that enable an individual to perceive, store, interpret and restore information from the surrounding. (8) Studies have shown that patients with B thalassemia have impairment in most of these cognitive functions in comparison to their healthy counterparts.

psychological problems as stress, anxiety, and depression are some of the psychological disorders that negatively impact the lives of thalassemia patients and may cause multiple comorbidities if not managed properly (9) Quality of life is assessed by focusing on the person's own view of his/her life and his/her well-being taking any conditions or issues that may affect the person's life into consideration. (10) Multiple studies showed the negative impact thalassemia disease and its therapy have on the cognition of these patients. This study aims to assess and compare the cognition, psychological impact and quality of life among patients with B thalassemia major, requiring regular blood transfusion, patients with B thalassemia intermedia, who don't, and healthy controls. Thus, estimating the role of blood transfusion and hemosiderosis in cognitive impairment, psychological symptoms, and low quality of life in these patients.

Eligibility criteria: Inclusion Criteria:

* Age above 18 years.
* Patients diagnosed as B thalassemia major and intermedia by Hb Electrophoresis.

Exclusion Criteria:

* Neurological or any other medical disease.
* IQ less than 70.
* Past history or family history of any psychiatric disorders.

Primary outcomes:
measure: Assessment of Cognitive functions among B Thalassemia Patients
timeFrame: one year
measure: Assessment of Psychological Symptoms among B Thalassemia Patients
timeFrame: one year
measure: Assessment Quality of life among B Thalassemia Patients
timeFrame: one year
Secondary outcomes:
Other outcomes:
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Study officials:
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