Pharmacist-led Intervention on Hemodialysis Patients' Therapy Adherence

NCT06744738 | Completed DMC

• 1 other identifier: RECAUCP8720246
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis; End Stage Renal Disease Requiring Hemodialysis

Keywords

Adherences; Chronic kidney disease; ESRD; Behavioral intervention

Outcome Measures

Primary Outcomes (1)

• End Stage Renal Disease Adherence Questionnaire (ESRD-AQ) scores

  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)

  At the start of the study, and after one month of the start of the study.

Secondary Outcomes (4)

• Serum Phosphate

  At the start of the study, and after one month of the start of the study.

• Interdialytic weight gain (IDWG)

  At the start of the study, and after one month of the start of the study.

• Total serum Calcium

  At the start of the study, and after one month of the start of the study.

• Hemoglobin levels

  At the start of the study, and after one month of the start of the study.

Study Arms (2)

Usual care

NO INTERVENTION

The usual care group received the usual care offered by the center to all patients, which included printed, paper-based, and verbal instructions. The written material included knowledge about diet recommendations for dialysis patients based on National Kidney Foundation recommendations. Verbal instructions were provided by the physician, including information regarding their medications, dialysis, diet, and fluid intake based on their condition and monthly lab results. Medications are provided to all patients at no cost, and pharmacists provide instructions on how to use them.

pharmacist-led behavioral change technique

EXPERIMENTAL

The intervention was developed based on the behavior change technique taxonomy (v1). This intervention was designed to improve adherence to all therapeutic aspects of hemodialysis patients, including the dialysis program, medications, diet, and fluids. Additionally, the effect of the pharmacist intervention on physiological indices (serum potassium, total calcium, phosphate, IDWG, and hemoglobin) was examined. The program was explicitly created for implementation in an actual setting, ensuring that the time allocation for participants and facilitators (the party responsible for conducting the PL-BCT) remained reasonable in most contexts. The BCT components were developed after the identification and coding of the BCTs from previous interventional studies that contain behavioral components and result in positive effects on one or more hemodialysis patients' adherence domains toward their therapeutic regimen (dialysis program, medications, diet, and fluid).

Behavioral: Pharmacist led behavioral change technique

Interventions

Pharmacist led behavioral change technique BEHAVIORAL

The intervention was developed based on the behavior change technique taxonomy (v1). This intervention was designed to improve adherence to all therapeutic aspects of hemodialysis patients, including the dialysis program, medications, diet, and fluids. Additionally, the effect of the pharmacist intervention on physiological indices (serum potassium, total calcium, phosphate, IDWG, and hemoglobin) was examined. The program was explicitly created for implementation in an actual setting, ensuring that the time allocation for participants and facilitators (the party responsible for conducting the PL-BCT) remained reasonable in most contexts. The BCT components were developed after the identification and coding of the BCTs from previous interventional studies that contain behavioral components and result in positive effects on one or more hemodialysis patients' adherence domains toward their therapeutic regimen (dialysis program, medications, diet, and fluid).

pharmacist-led behavioral change technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thuraya Safaa Ibrahim: lead

Study Sites (1)

Baghdad Medical City

Baghdad, 10047, Iraq

Location

Related Publications (1)

• Ansaf TS, Al-Hamadani FY, Brown S, James DH. Pharmacist-led behavioral change intervention improves adherence and clinical outcomes among hemodialysis patients. Sci Rep. 2025 Sep 29;15(1):33661. doi: 10.1038/s41598-025-18082-y.

  PMID: 41023004 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 20, 2024
• Study Start: February 2, 2024
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

IR (1)