Pharmacist-led Intervention on Hemodialysis Patients' Therapy Adherence

Not Applicable

Completed

• Conditions: Hemodialysis; End Stage Renal Disease Requiring Hemodialysis

• Registration Number: NCT06744738
• Lead Sponsor: Thuraya Safaa Ibrahim

Brief Summary

A parallel-group, cluster-randomized, controlled trial designed to evaluate if hemodialysis patients benefit from BCT. The study includes two groups: usual care and pharmacist-led intervention groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-02
• Primary Completion: 2024-06-25
• Study Completion: 2024-06-25
• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Adults (≥18 years of age), chronic kidney disease patients on standard in-center hemodialysis for at least three months, patients receiving 4 hours per session, moderate to poor adherence to their therapeutic regimen according to End Stage Renal Disease Adherence Questionnaire (ESRD-AQ) at the time of inclusion

Exclusion Criteria

• Switching from hemodialysis to peritoneal dialysis, receiving transplantation during the research period, inability to communicate for any reason (cognitive impairment, hearing and visual loss, etc.), hemodialysis patients with viral hepatitis, and patient refusal to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
End Stage Renal Disease Adherence Questionnaire (ESRD-AQ) scores	At the start of the study, and after one month of the start of the study.	The ESRD-AQ is a comprehensive tool that records critical elements of patients' treatment history: self-reported treatment adherence (including HD attendance, prescriptions, fluid restrictions, and dietary recommendations); perceptions regarding adherence behaviors; and justifications for nonadherence. ESRD-AQ consists of 46 questions, scores range from 0 to 1,200, with higher scores signify better adherence. Scores are divided into three ranges to identify adherence behavior (good adherence scores range between 1000 to 1200, moderate adherence scores range between 700 to 999, and poor adherence scores are less than 700). The scores were distributed over the four dimensions as follows: adherence to HD sessions (scores 0 - 600), adherence to dietary recommendations (scores 0 - 200), adherence to medications (scores 0 - 200), and adherence to fluid restriction (scores 0 - 200)

Secondary Outcome Measures

Name	Time	Method
Serum Phosphate	At the start of the study, and after one month of the start of the study.	Serum Phosphate levels measurement
Interdialytic weight gain (IDWG)	At the start of the study, and after one month of the start of the study.	Interdialytic weight gain (IDWG) Assessment
Total serum Calcium	At the start of the study, and after one month of the start of the study.	Total serum Calcium measurement
Hemoglobin levels	At the start of the study, and after one month of the start of the study.	Measurement of patients Hemoglobin levels

Trial Locations

Locations (1)

Baghdad Medical City; 🇮🇶 Baghdad, Iraq