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
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment|
|β-thalassemia||Other: The Medical Outcomes Short-Form 36-Item Health Survey (SF-36v2) It|
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 Type :||Observational|
|Estimated Enrollment :||75 participants|
|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|
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 :
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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|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|
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
- primary haemochromatosis
- thalassemia minor patients
- preseance of systemic disease that prevent patient from treatment ,
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
|Contact: Osama A Ibrahiem, Profemail@example.com|
|Contact: Rania M Hafez, firstname.lastname@example.org|
|Assiut University Hospital|
|Assiut, Egypt, Assiut University71515|
|Responsible Party:||Rania, Principal Investigator, Assiut University|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn