Thalassemia Particularly Transfusion Dependent ThalassemiaHBT-sohagNCT07796022
Clinical, Economic,and Psychosocial Burden of Thalassemia in Sohag
An observational study of Thalassemia Particularly Transfusion Dependent Thalassemia, run by Randa Elham Hamam.
Trial summary
This study aims to assess the clinical, economic, and psychosocial burden of thalassemia among affected children in Sohag. Clinically, the study will evaluate disease severity, transfusion requirements, iron overload, complications, and treatment-related factors. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Thalassemia Particularly Transfusion Dependent Thalassemia
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Jul 2027
- Phase
- Observational
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study will include children and adolescents diagnosed with thalassemia who are attending pediatric hematology clinics of Sohag University Hospitals for regular follow-up, blood transfusion, or chelation therapy.
Inclusion Criteria: Children and adolescents diagnosed with thalassemia. Age from 2 to 18 years. Regular follow-up at the selected pediatric hematology clinic or thalassemia unit
Exclusion Criteria:Children with other chronic hematological disorders unrelated to thalassemia.
Children with severe acute illness at the time of data collection. Children or caregivers who refuse participation.
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Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Hidden Burden of Thalassemia in Sohag Clinical Economic and Psychosocial Perspectives
This study aims to assess the clinical, economic, and psychosocial burden of thalassemia among affected children in Sohag. Clinically, the study will evaluate disease severity, transfusion requirements, iron overload, complications, and treatment-related factors. Economically, it will estimate direct medical costs, including transfusions, medications, investigations, hospital visits, and other healthcare expenses, as well as indirect costs such as school/work absenteeism and caregiver burden. Psychosocial aspects will include assessment of quality of life, psychological well-being, social functioning, and the impact of the disease on patients and their families.
Read the detailed description
Thalassemia constitutes one of the most common inherited hemoglobin disorders worldwide and remains a major public health problem in Egypt, where carrier rates approach 9-10% and both alpha and beta thalassemia gene defects are well documented in the population . In Egypt, the burden of disease is particularly evident among pediatric patients with transfusion dependent beta thalassemia (TDT), who require lifelong regular blood transfusions and iron chelation therapy and are consequently at risk of iron overload, organ damage, and transfusion transmitted infections despite improvements in transfusion safety .
Regional studies from Upper Egypt have documented a high frequency of transfusion related complications in multitransfused children, including elevated rates of hepatitis C and other infections, and have highlighted ongoing gaps in screening and blood safety practices that continue to contribute to clinical morbidity . Concurrently, quality of life (QoL) research in Egyptian pediatric thalassemia populations demonstrates consistent and clinically meaningful impairments across physical, emotional, social, and school functioning domains, with socioeconomic disadvantage and markers of greater disease severity (for example, higher ferritin and longer disease duration) associated with worse outcomes .
Beyond direct clinical consequences, thalassemia imposes a substantial economic and psychosocial burden on families and health systems . Cost analyses and health resource studies indicate significant direct medical expenses and large indirect costs from caregiver absenteeism, transport, and lost productivity, and these burdens are magnified in low resource settings where comprehensive social support is limited. Cultural factors such as high rates of consanguineous marriage and variable uptake of premarital screening in Egypt also influence disease prevalence and complicate prevention strategies
- Keywords
- Thalassemia, transfusion dependent Thalassemia, children, Sohag, clinical burden, economic burden, psychosocial burden
- Medical subject headings
- Thalassemia, Financial Stress
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 |
|---|---|---|
| Children and adolescents diagnosed with Thalassemia aged from 2_18 yrs | No experimental intervention data Will be collected from routine clinical care ,medical records,and follow up visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical burden of thalassemia
Clinical burden will be assessed using the frequency of hospital admissions, blood transfusion requirements, and disease-related complications among children and adolescents with thalassemia.
Measured: through study completion, an average of 1 year
Economic burden of thalassemia
Economic burden will be assessed based on direct medical costs, including costs of medications, blood transfusions, laboratory investigations, hospitalizations, and other healthcare utilization.
Measured: through study completion, an average of 1 year
Psychosocial burden of thalassemia
Psychosocial burden will be assessed using the Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales (PedsQL 4.0), Family APGAR questionnaire, and Patient Health Questionnaire-4 (PHQ-4). The PedsQL 4.0 consists of 23 items and is scored on a 0-100 scale, with higher scores indicating better health-related quality of life. The Family APGAR consists of 5 items with a total score ranging from 0 to 10, with higher scores indicating better family functioning. The PHQ-4 consists of 4 items with a total score ranging from 0 to 12, with higher scores indicating greater psychological distress. The GAD-2 and PHQ-2 subscale scores each range from 0 to 6, with higher scores indicating greater anxiety and depressive symptoms, respectively.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thalassemia Particularly Transfusion Dependent ThalassemiaStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Randa Elham Hamam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Randa Elham Hamam, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796022
- Sponsor's protocol ID
- Soh_Med_26_7_32Ms
- Acronym
- HBT-sohag
- Status last verified
- Jul 2026
- First submitted
- 21 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individuals participant data will not be shared due to patients privacy and data protection policies at Sohag university hospital