Quality of Life and Treatment Satisfaction in β-Thalassemia Patients Receiving Deferasirox

• Conditions: β-thalassemia
• Interventions: Other: The Medical Outcomes Short-Form 36-Item Health Survey (SF-36v2) It

• Registration Number: NCT03358498
• Lead Sponsor: Assiut University

Brief Summary

Regular blood transfusions are essential for the management of haematological conditions such as β-thalassemia major. As a result, however, patients with these conditions are susceptible to the development of transfusion-dependent iron overload (hemosiderosis or secondary iron overload

Detailed Description

In the absence of a naturally occurring physiological mechanism for the removal of excess iron in the body, life-long treatment and adherence to iron chelation therapy (ICT) are necessary to prevent the morbidity and mortality that may result if excess iron is allowed to .

Deferasirox (DFO),is the oldest available form of ICT used by patients with transfusion-dependent disorders. Improvements in ICT administration convenience and tolerability are expected to improve patient's satisfaction with ICT and Health Related Quality of Life (HRQOL), thus promoting adherence to ICT regimens and potentially reducing iron overload-related morbidity/mortality and associated healthcare costs

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-11-27
• Last Update Submitted: 2017-11-27
• Study First Posted: 2017-11-30
• Last Update Posted: 2017-11-30
• Study Start: 2017-12-01
• Primary Completion: 2018-12-01
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1 - Age more than 16 years 2-transfusion related iron over load (serum ferritin more than 1000 ng/ml) 3-patients on oral iron chelation (deferasirox ) for one year or more

Exclusion

1. primary haemochromatosis
2. thalassemia minor patients
3. preseance of systemic disease that prevent patient from treatment ,

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
β-thalassemia group	The Medical Outcomes Short-Form 36-Item Health Survey (SF-36v2) It	SICT It is a questionnaire to assess patient satisfaction with ICT regimens. It comprises 19 items assessing four domains: perceived effectiveness of ICT (PE), burden of ICT (BD), acceptance of ICT (AC), and side effects of ICT (SE). Patients rate all items on scale from 1 "very dissatisfied" to 5 "very satisfied". Lab methods : 1. full history and thorough clinical evaluation. 2. . Complete blood count. .3- Serum ferritin . 4-Renal function tests. 5-liver function tests.

Primary Outcome Measures

Name	Time	Method
The Medical Outcomes Short-Form 36-Item Health Survey (SF-36v2)	Baseline	- The Medical Outcomes Short-Form 36-Item Health Survey (SF-36v2) It is a self-administered questionnaire comprising 36-items measuring eight dimensions of general HRQOL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items). In addition to scores for individual dimensions, two summary scores assessing physical and mental dimensions of health and well-being can also be calculated: Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score, respectively

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt