Skip to main content
OpenTrials
Completed

NCT Number: NCT06210139

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

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 .

Completed

Looking for future studies?

Notify Me

Key information

Age range

3 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AL Zahar teaching Hospital

Najaf, 54001, Iraq

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  1. prescribing pattern

    Time frame: Baseline

    describe the pharmacotherapy prescribing pattern in thalassemia

  2. Association of patient's factors with poor adherence

    Time frame: Baseline

    exploring the association between patient's factors with adherence level by multivariate analysis

Sponsors and collaborators

Lead sponsor

Reem Ali Shaker

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 18, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.