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

Assiut University

Status: Unknown

Conditions: β-thalassemia

Treatments: Other: The Medical Outcomes Short-Form 36-Item Health Survey (SF-36v2) It

Study type: Observational

Funder types: Other

Identifiers

NCT03358498

QOLATSIBTPRD

Details and patient eligibility

About

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

Full 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

Enrollment: 75 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 ,

Trial design

75 participants in 1 patient group

β-thalassemia group

Description:

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.

Treatment:

Other: The Medical Outcomes Short-Form 36-Item Health Survey (SF-36v2) It