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临床试验/NCT06210139
NCT06210139已完成不适用

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

Reem Ali Shaker1 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2023年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
199
试验地点
1
主要终点
Adherence level

研究概览

简要总结

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 .

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
3 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Adherence level

时间窗: 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

时间窗: 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%

次要结局

  • prescribing pattern(Baseline)
  • Association of patient's factors with poor adherence(Baseline)

研究者

发起方
Reem Ali Shaker
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Reem Ali Shaker

Principle investigator

Kufa University

研究点 (1)

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