B ThalassemiaNCT05105659
Assessment of Cognitive Functions, Psychological Symptoms, and Quality of Life Among B Thalassemia Patients and Their Clinical Correlates.
An observational study of B Thalassemia, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- B Thalassemia
- What is being tested?
- Wechsler IQ for Adults, MAS (Memory assessment scale) and Health-Related Quality of Life (HRQoL)
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2021to 20 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age above 18 years.
- Patients diagnosed as B thalassemia major and intermedia by Hb Electrophoresis.
Who cannot join
- Neurological or any other medical disease.
- IQ less than 70.
- Past history or family history of any psychiatric disorders.
About this study
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.
Read the 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.
- Conditions
- B Thalassemia
- Being tested
- Wechsler IQ for Adults, MAS (Memory assessment scale), Health-Related Quality of Life (HRQoL), Symptom check list 90, Socioeconomic level
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wechsler IQ for AdultsDiagnostic 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)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)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 90Diagnostic 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 levelDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| B thalassemia Major patients | Not described Receives: Diagnostic Test: Wechsler IQ for Adults; Diagnostic Test: MAS (Memory assessment scale); Diagnostic Test: Health-Related Quality of Life (HRQoL); Diagnostic Test: Symptom check list 90; Diagnostic Test: Socioeconomic level | |
| B thalassemia Intermedia patients | Not described Receives: Diagnostic Test: Wechsler IQ for Adults; Diagnostic Test: MAS (Memory assessment scale); Diagnostic Test: Health-Related Quality of Life (HRQoL); Diagnostic Test: Symptom check list 90; Diagnostic Test: Socioeconomic level | |
| Healthy Controls | Not described Receives: Diagnostic Test: Wechsler IQ for Adults; Diagnostic Test: MAS (Memory assessment scale); Diagnostic Test: Health-Related Quality of Life (HRQoL); Diagnostic Test: Symptom check list 90; Diagnostic Test: Socioeconomic level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Cognitive functions among B Thalassemia Patients
Measured: one year
Assessment of Psychological Symptoms among B Thalassemia Patients
Measured: one year
Assessment Quality of life among B Thalassemia Patients
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start20 Dec 2021 (estimated)
- Primary completion20 Dec 2022 (estimated)
- Study completion20 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B ThalassemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alya Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105659
- Sponsor's protocol ID
- 45545
- Status last verified
- Oct 2021
- First submitted
- 25 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cognitive Functions, Psychological Symptoms, and Quality of Life Among B Thalassemia Patients and Their Clinical Correlates.
- ClinicalTrials.gov ID
- NCT05105659
- Acronym / sponsor ID
- 45545
- Conditions
- B Thalassemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Dec 2021 (estimated)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 20 Feb 2023 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B thalassemia Major patients | – | Diagnostic Test: Wechsler IQ for Adults, Diagnostic Test: MAS (Memory assessment scale), Diagnostic Test: Health-Related Quality of Life (HRQoL), Diagnostic Test: Symptom check list 90, Diagnostic Test: Socioeconomic level |
| B thalassemia Intermedia patients | – | Diagnostic Test: Wechsler IQ for Adults, Diagnostic Test: MAS (Memory assessment scale), Diagnostic Test: Health-Related Quality of Life (HRQoL), Diagnostic Test: Symptom check list 90, Diagnostic Test: Socioeconomic level |
| Healthy Controls | – | Diagnostic Test: Wechsler IQ for Adults, Diagnostic Test: MAS (Memory assessment scale), Diagnostic Test: Health-Related Quality of Life (HRQoL), Diagnostic Test: Symptom check list 90, Diagnostic Test: Socioeconomic level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age above 18 years.
- Patients diagnosed as B thalassemia major and intermedia by Hb Electrophoresis.
Key exclusion criteria (3 listed)
- Neurological or any other medical disease.
- IQ less than 70.
- Past history or family history of any psychiatric disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wechsler IQ for AdultsIQ test that measures the cognitive functions and intelligence using a scale and consists of many subtests assessing verbal and non-verbal performance. | Diagnostic test | B thalassemia Intermedia patients, B thalassemia Major patients, Healthy Controls |
| 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. | Diagnostic test | B thalassemia Intermedia patients, B thalassemia Major patients, Healthy Controls |
| 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. | Diagnostic test | B thalassemia Intermedia patients, B thalassemia Major patients, Healthy Controls |
| Symptom check list 90a 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. | Diagnostic test | B thalassemia Intermedia patients, B thalassemia Major patients, Healthy Controls |
| Socioeconomic levelscale 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. | Diagnostic test | B thalassemia Intermedia patients, B thalassemia Major patients, Healthy Controls |
Primary outcome
Assessment of Cognitive functions among B Thalassemia Patients
Time frame: one year
Assessment of Psychological Symptoms among B Thalassemia Patients
Time frame: one year
Assessment Quality of life among B Thalassemia Patients
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of B Thalassemia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Cognitive functions among B Thalassemia Patients (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.