Clinical trial NCT06210139: Pharmacotherapy Prescribing Pattern and the Adherence Level to Iron Chelation Therapy in Thalassemia
Official title: Evaluating the Prescribing Pattern and Knowledge, Attitude and Practice as Well as the Adherence Level to Iron Chelation Therapy in Thalassemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thalassemia
Keywords: thalassemia
prescribing pattern
knowledge
adherence
Lead sponsor: Kufa University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 199
Sex: ALL
Minimum age (years): 3
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted on the patients diagnosed with thalassemia and treated with iron chelation therapy who admitted to thalassemia center of AL Zahraa teaching hospital in AL Najaf Governorate-Iraq

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

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.

Primary outcomes:
measure: Adherence level
timeFrame: Baseline
measure: KAP score
timeFrame: Baseline
Secondary outcomes:
measure: prescribing pattern
timeFrame: Baseline
measure: Association of patient's factors with poor adherence
timeFrame: Baseline
Other outcomes:
Locations:
city: Najaf
country: Iraq
facility: AL Zahar teaching Hospital
Study officials:
affiliation: Kufa university/ faculty of pharmacy
name: Fadhil A Riziji, PhD
role: STUDY_DIRECTOR
References: