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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03358498
Recruitment Status : Unknown
Verified November 2017 by Rania, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Rania, Assiut University

Study Description
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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

Condition or disease Intervention/treatment
β-thalassemia Other: The Medical Outcomes Short-Form 36-Item Health Survey (SF-36v2) It

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 Design
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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Quality of Life and Treatment Satisfaction in β-Thalassemia Patients Receiving Deferasirox
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia

Groups and Cohorts
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Group/Cohort Intervention/treatment
β-thalassemia group

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.

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

SF-36v2 is questionnaire comprising 36items measuring eight dimensions of general HRQOL: physical functioning 10 items, 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.

.

Other Name: Satisfaction with ICT Questionnaire (SICT) Complete blood count. - Serum ferritin . -Renal function tests. -liver function tests.


Outcome Measures
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Primary Outcome Measures :
  1. The Medical Outcomes Short-Form 36-Item Health Survey (SF-36v2) [ Time Frame: 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Seventy five thalassemic patients will be included in the study from haematology unit in internal medicine department in Assiut University Hospital.
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 ,
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358498


Contacts
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Contact: Osama A Ibrahiem, Prof 00201006372498 oibrahiem@yahoo.com
Contact: Rania M Hafez, doctor 00201000019198 raniahafez@ymail.com

Locations
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Egypt
Assiut University Hospital
Assiut, Egypt, Assiut University71515
Sponsors and Collaborators
Assiut University
More Information
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Publications:

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Responsible Party: Rania, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03358498    
Other Study ID Numbers: QOLATSIBTPRD
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn