Assessment of Cognitive Functions, Psychological Symptoms, and Quality of Life Among B Thalassemia Patients and Their Clinical Correlates.

NCT ID: NCT05105659

Last Updated: 2021-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-20

Study Completion Date

2023-02-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

B Thalassemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

B thalassemia Major patients

Wechsler IQ for Adults

Intervention Type DIAGNOSTIC_TEST

IQ test that measures the cognitive functions and intelligence using a scale and consists of many subtests assessing verbal and non-verbal performance.

MAS (Memory assessment scale)

Intervention Type DIAGNOSTIC_TEST

tool that uses verbal and the visual tasks to assess memory, recall and cognition. The MAS consists of 12 subtests based on the following 7 memory tasks: Verbal Span, List Learning, Prose memory, Visual Span, Visual Recognition, Visual Reproduction and Names-Faces.

Health-Related Quality of Life (HRQoL)

Intervention Type DIAGNOSTIC_TEST

measures multiple aspects of the individual's life and the impact of the disease and treatment on the individual's life. It does so by assessing the individual's own views and perspective of the care and treatment they are receiving and whether consider it satisfactory or not.

Symptom check list 90

Intervention Type DIAGNOSTIC_TEST

a well-known scale that is used to identify and assess psychological symptoms. It consists of a 90-item checklist having a 5-point rating scale.

Socioeconomic level

Intervention Type DIAGNOSTIC_TEST

scale for measurement of socioeconomic status in health research in Egypt. The new socioeconomic status scale has 7 domains with a total score of 84. Intra-and inter-observer variability and the internal consistency of the scale were assessed.

B thalassemia Intermedia patients

Wechsler IQ for Adults

Intervention Type DIAGNOSTIC_TEST

IQ test that measures the cognitive functions and intelligence using a scale and consists of many subtests assessing verbal and non-verbal performance.

MAS (Memory assessment scale)

Intervention Type DIAGNOSTIC_TEST

tool that uses verbal and the visual tasks to assess memory, recall and cognition. The MAS consists of 12 subtests based on the following 7 memory tasks: Verbal Span, List Learning, Prose memory, Visual Span, Visual Recognition, Visual Reproduction and Names-Faces.

Health-Related Quality of Life (HRQoL)

Intervention Type DIAGNOSTIC_TEST

measures multiple aspects of the individual's life and the impact of the disease and treatment on the individual's life. It does so by assessing the individual's own views and perspective of the care and treatment they are receiving and whether consider it satisfactory or not.

Symptom check list 90

Intervention Type DIAGNOSTIC_TEST

a well-known scale that is used to identify and assess psychological symptoms. It consists of a 90-item checklist having a 5-point rating scale.

Socioeconomic level

Intervention Type DIAGNOSTIC_TEST

scale for measurement of socioeconomic status in health research in Egypt. The new socioeconomic status scale has 7 domains with a total score of 84. Intra-and inter-observer variability and the internal consistency of the scale were assessed.

Healthy Controls

Wechsler IQ for Adults

Intervention Type DIAGNOSTIC_TEST

IQ test that measures the cognitive functions and intelligence using a scale and consists of many subtests assessing verbal and non-verbal performance.

MAS (Memory assessment scale)

Intervention Type DIAGNOSTIC_TEST

tool that uses verbal and the visual tasks to assess memory, recall and cognition. The MAS consists of 12 subtests based on the following 7 memory tasks: Verbal Span, List Learning, Prose memory, Visual Span, Visual Recognition, Visual Reproduction and Names-Faces.

Health-Related Quality of Life (HRQoL)

Intervention Type DIAGNOSTIC_TEST

measures multiple aspects of the individual's life and the impact of the disease and treatment on the individual's life. It does so by assessing the individual's own views and perspective of the care and treatment they are receiving and whether consider it satisfactory or not.

Symptom check list 90

Intervention Type DIAGNOSTIC_TEST

a well-known scale that is used to identify and assess psychological symptoms. It consists of a 90-item checklist having a 5-point rating scale.

Socioeconomic level

Intervention Type DIAGNOSTIC_TEST

scale for measurement of socioeconomic status in health research in Egypt. The new socioeconomic status scale has 7 domains with a total score of 84. Intra-and inter-observer variability and the internal consistency of the scale were assessed.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Wechsler IQ for Adults

IQ test that measures the cognitive functions and intelligence using a scale and consists of many subtests assessing verbal and non-verbal performance.

Intervention Type DIAGNOSTIC_TEST

MAS (Memory assessment scale)

tool that uses verbal and the visual tasks to assess memory, recall and cognition. The MAS consists of 12 subtests based on the following 7 memory tasks: Verbal Span, List Learning, Prose memory, Visual Span, Visual Recognition, Visual Reproduction and Names-Faces.

Intervention Type DIAGNOSTIC_TEST

Health-Related Quality of Life (HRQoL)

measures multiple aspects of the individual's life and the impact of the disease and treatment on the individual's life. It does so by assessing the individual's own views and perspective of the care and treatment they are receiving and whether consider it satisfactory or not.

Intervention Type DIAGNOSTIC_TEST

Symptom check list 90

a well-known scale that is used to identify and assess psychological symptoms. It consists of a 90-item checklist having a 5-point rating scale.

Intervention Type DIAGNOSTIC_TEST

Socioeconomic level

scale for measurement of socioeconomic status in health research in Egypt. The new socioeconomic status scale has 7 domains with a total score of 84. Intra-and inter-observer variability and the internal consistency of the scale were assessed.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alya Mohamed

Resident Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

45545

Identifier Type: -

Identifier Source: org_study_id