Evaluating the Prescribing Pattern and Knowledge, Attitude and Practice as Well as the Adherence Level to Iron Chelation Therapy in Thalassemia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Thalassemia
- Sponsor
- Reem Ali Shaker
- Enrollment
- 199
- Locations
- 1
- Primary Endpoint
- Adherence level
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Thalassemias are a heterogeneous grouping of genetic disorders that result in dysfunctional Hb, reduced RBC life span leading to chronic anemia . Thalassemia is endemic in the Middle East. Iron chelation therapy (ICT) is one of treatment used however ICT is associated with patients adherence problem thus impacting its effectiveness .
Detailed Description
Thalassemias are a heterogeneous grouping of genetic disorders that result from a decreased synthesis of alpha or beta chains of hemoglobin resulting in dysfunctional Hb, reduced RBC life span and hemolytic anemia as well as ineffective erythropoiesis leading to chronic anemia. Thalassemia is endemic in the Middle East, the Mediterranean region, and Southeast Asia, its prevalence in these region range from 7%-10%. There are 3 iron chelators licensed for clinical use, namely, deferoxamine (DFO), deferiprone (DFP), and deferasirox (DFX). Advancement in blood transfusions and ICT transforms this disease from fatal childhood disease to adult chronic disease . From other side, thalassemic patients on ICT suffering from therapy related challenge such as nonadherence, Nonadherence to ICT remains a long-standing and serious issue in thalassemia with ranges from 30% to 80% World widely. Issue of nonadherence and suboptimal responsiveness to ICT is complex and multifactorial such as side effects and administrations on top of inadequate knowledge and practice lead to reduced adherence to ICT thus increasing morbidity and mortality
Investigators
Reem Ali Shaker
Principle investigator
Kufa University
Eligibility Criteria
Inclusion Criteria
- •male and female patients with age above 3 years old diagnosed with thalassemia,
- •having iron overload
- •taken Iron chelation therapy
- •having the acceptance to participate in the study.
Exclusion Criteria
- •renal and hepatic impairment,
- •Allergic to any drug of the study
- •history of viral hepatitis or HIV
- •Gastrointestinal disorder affecting drug absorption.
- •psychiatric disorder affecting consent agreement and unable to comply with study.
Outcomes
Primary Outcomes
Adherence level
Time Frame: Baseline
assessing patient adherence level to oral iron chelation therapy by Morisky medication adherence scale- 8 ( score less than 6 considered as low adherence , 6-7 medium adherence and 8 score considered as high adherence
KAP score
Time Frame: Baseline
assessment of KAP( knowledge , attitude and practice) by using modified Bloom's cut-off value of 70% was used to classify patient's KAP into poor/negative for those with score below 70% and good/positive for those with score above 70%
Secondary Outcomes
- prescribing pattern(Baseline)
- Association of patient's factors with poor adherence(Baseline)