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

NCT06210139 | Completed

• 1 other identifier: MEC-40
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 1

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 .

Conditions

Thalassemia

Keywords

thalassemia; prescribing pattern; knowledge; adherence

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• prescribing pattern

  Baseline

• Association of patient's factors with poor adherence

  Baseline

Eligibility Criteria

• Age: 3 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reem Ali Shaker: lead

Study Sites (1)

AL Zahar teaching Hospital

Najaf, 54001, Iraq

Location

MeSH Terms

Conditions

Thalassemia

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Fadhil A Riziji, PhD

  Kufa university/ faculty of pharmacy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 18, 2024
• Study Start: March 28, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)