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Enrolling by Invitation

NCT Number: NCT07080840

Phosphorus Education and Adherence in Hemodialysis Patients

By applying statistical methods such as analysis of variance (ANOVA), this study incorporates both the content and the intensity (frequency) of educational interventions to design multiple regression models for evaluating education strategies. Through each round of laboratory data, the investigators aim to identify the most effective educational model using empirical data. The findings will not only improve phosphorus management and enhance the quality of care but also reduce unnecessary nursing workload and help establish an optimal educational protocol and training framework.

Based on literature review and clinical experience, it is well recognized that, in addition to receiving regular and adequate dialysis, effective phosphorus control relies heavily on patients' daily dietary selection and the appropriate use and frequency of phosphate binders. Hence, this study aims to investigate the correlation between phosphorus control and patient education delivered by nursing staff, focusing on dietary management, phosphate binder usage, and knowledge of dialysis principles.

By applying statistical methods such as analysis of variance (ANOVA), this study incorporates both the content and the intensity (frequency) of educational interventions to design multiple regression models for evaluating education strategies. Through each round of laboratory data, we aim to identify the most effective educational model using empirical data. The findings will not only improve phosphorus management and enhance the quality of care but also reduce unnecessary nursing workload and help establish an optimal educational protocol and training framework.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wei-Hua

Taichung, 412224, Taiwan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients who have been on dialysis for more than one year, have intact self-awareness, and are currently taking phosphate-binding medications.

Exclusion criteria

  • Patients who have been on dialysis for less than one year, lack self-awareness, or are not taking phosphate-lowering medications.

Treatment and study plan

Nursing education A+1

Behavioral

Dietary education once

Nursing education A+2

Behavioral

Dietary education twice

Nursing education A+3

Behavioral

Dietary education three times

Nursing education B+1

Behavioral

Medication education once

Nursing education B+2

Behavioral

Medication education twice

Nursing education B+3

Behavioral

Medication education three times

Nursing education AB+1

Behavioral

Combined dietary and medication education once

Nursing education AB+2

Behavioral

Combined dietary and medication education twice

Nursing education AB+3

Behavioral

Combined dietary and medication education three times

Primary outcomes

  1. phosphate

    Time frame: Baseline and every 2 weeks until Week 12 (August 19 to November 4, 2025)

    Serum phosphorus levels were measured every two weeks during the 12-week intervention period. Blood samples were collected on Monday or Tuesday, aligned with the patient's hemodialysis cycle (W123 or W246), beginning August 19 and ending November 4, 2025. A total of 6 blood draws were performed. All samples were taken pre-dialysis via venipuncture, with each draw limited to 20 mL and total sample volume not exceeding 320 mL over the study period.

    it is expedited review according to Take blood samples from fingers, heels, ears, or veins of an adult weighing more than 50 kg. Also, the total amount of sample collection should not be more than 320 ml in 8 weeks and should not be more than twice a week. The amount of each blood collection should not be more than 20 ml.

Sponsors and collaborators

Lead sponsor

Jen-Ai Hospital Institutional Review Board

Industry

Registry information

Official study title

Adherence as a Moderator of Phosphorus Education Effectiveness in Hemodialysis Patients: an Exploratory Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

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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