NCT05105659

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 20, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
Last Updated

November 3, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

October 25, 2021

Last Update Submit

October 25, 2021

Conditions

B Thalassemia

Outcome Measures

Primary Outcomes (3)

  • Assessment of Cognitive functions among B Thalassemia Patients

    one year

  • Assessment of Psychological Symptoms among B Thalassemia Patients

    one year

  • Assessment Quality of life among B Thalassemia Patients

    one year

Study Arms (3)

B thalassemia Major patients

Diagnostic Test: Wechsler IQ for AdultsDiagnostic Test: MAS (Memory assessment scale)Diagnostic Test: Health-Related Quality of Life (HRQoL)Diagnostic Test: Symptom check list 90Diagnostic Test: Socioeconomic level

B thalassemia Intermedia patients

Diagnostic Test: Wechsler IQ for AdultsDiagnostic Test: MAS (Memory assessment scale)Diagnostic Test: Health-Related Quality of Life (HRQoL)Diagnostic Test: Symptom check list 90Diagnostic Test: Socioeconomic level

Healthy Controls

Diagnostic Test: Wechsler IQ for AdultsDiagnostic Test: MAS (Memory assessment scale)Diagnostic Test: Health-Related Quality of Life (HRQoL)Diagnostic Test: Symptom check list 90Diagnostic Test: Socioeconomic level

Interventions

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.

B thalassemia Intermedia patientsB thalassemia Major patientsHealthy Controls
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.

B thalassemia Intermedia patientsB thalassemia Major patientsHealthy Controls
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.

B thalassemia Intermedia patientsB thalassemia Major patientsHealthy Controls
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.

B thalassemia Intermedia patientsB thalassemia Major patientsHealthy Controls
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.

B thalassemia Intermedia patientsB thalassemia Major patientsHealthy Controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

beta-Thalassemia

Condition Hierarchy (Ancestors)

ThalassemiaAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

October 25, 2021

First Posted

November 3, 2021

Study Start

December 20, 2021

Primary Completion

December 20, 2022

Study Completion

February 20, 2023

Last Updated

November 3, 2021

Record last verified: 2021-10