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

Thalassemia Clinical Trial

Official title:

Evaluating the Prescribing Pattern and Knowledge, Attitude and Practice as Well as the Adherence Level to Iron Chelation Therapy in Thalassemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06210139
• Other study ID #: MEC-40
• Status: Recruiting
• Start date: March 28, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: January 2024
• Source: Kufa University
• Contact: Reem A Shaker, Master
• Phone: 009647706856245
• Email: reem.shaker83[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Thalassemia

Locations

Country	Name	City	State
Iraq	AL Zahar teaching Hospital	Najaf

Sponsors (1)

Lead Sponsor	Collaborator
Reem Ali Shaker

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence level	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	Baseline
Primary	KAP score	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%	Baseline
Secondary	prescribing pattern	describe the pharmacotherapy prescribing pattern in thalassemia	Baseline
Secondary	Association of patient's factors with poor adherence	exploring the association between patient's factors with adherence level by multivariate analysis	Baseline