Pharmacotherapy Prescribing Pattern and the Adherence Level to Iron Chelation Therapy in Thalassemia

Completed

• Conditions: Thalassemia

• Registration Number: NCT06210139
• Lead Sponsor: Reem Ali Shaker

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

Study Timeline

• Study Start: 2023-03-28
• Study First Submitted: 2023-12-22
• Study First Submitted QC: 2024-01-06
• Study First Posted: 2024-01-18
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence level	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	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 Outcome Measures

Name	Time	Method
prescribing pattern	Baseline	describe the pharmacotherapy prescribing pattern in thalassemia
Association of patient's factors with poor adherence	Baseline	exploring the association between patient's factors with adherence level by multivariate analysis

Trial Locations

Locations (1)

AL Zahar teaching Hospital; 🇮🇶 Najaf, Iraq