Cognitive ChangeNCT05469230
Assessment of Cognitive Function, Fatigue and Health Related Quality of Life in Children With Beta Thalassemia
An observational study of Cognitive Change and Beta-Thalassemia, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Beta-Thalassemia, Fatigue
- How many people
- 168 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2022to 30 May 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 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cognitive Change, Beta-Thalassemia, Fatigue, Quality of Life
- Medical subject headings
- beta-Thalassemia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessing the change in cognitive function
assessing the change in verbal comprehension, perceptual reasoning, processing speed, working memory and total IQ using Wecshler Intelligence Scale for Children (4th edition)
Measured: baseline to 6 months
Assessing the change in fatigue
assessing the change in General Fatigue,Sleep/Rest Fatigue and Cognitive Fatigue using Pediatric quality of life inventory multidimensional fatigue scale (child report)
Measured: Baseline to 6 months
Assessing the change in health related quality of life
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)
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start15 Jan 2022
- Primary completion30 Apr 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Elmorsi Abdelaziz Elderini Ibrahim, Cairo University
- Investigators
- Esraa ibrahim, M.Sc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469230
- Sponsor's protocol ID
- P.T.REC/012/003783
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cognitive Function, Fatigue and Health Related Quality of Life in Children With Beta Thalassemia
- ClinicalTrials.gov ID
- NCT05469230
- Acronym / sponsor ID
- P.T.REC/012/003783
- Conditions
- Cognitive Change, Beta-Thalassemia, Fatigue, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 21 Jul 2022 (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.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (7 listed)
- 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):
Key exclusion criteria (4 listed)
- Beta thalassemia group (study group): Any child Suffering from any other chronic diseases other than thalassemia
- Typically developed children (control group):
- any child suffering from medical illness, musculoskeletal deformities, visual and auditory problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
Esraa ibrahim, M.Sc principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Change and Beta-Thalassemia, run by Cairo University at 1 site in Egypt.
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
assessing the change in cognitive function (time frame: baseline to 6 months). 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 22 Jun 2023.