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Completed

NCT Number: NCT06744738

Pharmacist-led Intervention on Hemodialysis Patients' Therapy Adherence

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.

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Key information

Conditions

Hemodialysis Chronic Disease Disease Attributes End Stage Renal Disease Requiring Hemodialysis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baghdad Medical City

Baghdad, 10047, Iraq

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

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

    Time frame: 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 outcomes

  1. Serum Phosphate

    Time frame: At the start of the study, and after one month of the start of the study.

    Serum Phosphate levels measurement

  2. Interdialytic weight gain (IDWG)

    Time frame: At the start of the study, and after one month of the start of the study.

    Interdialytic weight gain (IDWG) Assessment

  3. Total serum Calcium

    Time frame: At the start of the study, and after one month of the start of the study.

    Total serum Calcium measurement

  4. Hemoglobin levels

    Time frame: At the start of the study, and after one month of the start of the study.

    Measurement of patients Hemoglobin levels

Sponsors and collaborators

Lead sponsor

Thuraya Safaa Ibrahim

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 20, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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