Phosphorus Education and Adherence in Hemodialysis Patients
Adherence as a Moderator of Phosphorus Education Effectiveness in Hemodialysis Patients: an Exploratory Study
1 other identifier
interventional
45
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 29, 2024
CompletedFirst Submitted
Initial submission to the registry
June 18, 2025
CompletedFirst Posted
Study publicly available on registry
July 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2025
CompletedJuly 23, 2025
July 1, 2025
12 months
June 18, 2025
July 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
phosphate
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.
Baseline and every 2 weeks until Week 12 (August 19 to November 4, 2025)
Study Arms (9)
Nursing Education A+1
EXPERIMENTALArm: A + 1 Patients received dietary education once. The session focused on phosphorus-rich food identification, dietary restrictions, and basic meal planning.
Nursing Education A+2
EXPERIMENTALArm: A + 2 Patients received dietary education twice. The program reinforced dietary knowledge through interactive review and provided individual nutrition tips.
Nursing Education A+3
EXPERIMENTALArm: A + 3 Patients received dietary education three times. Sessions included detailed meal planning, food label reading, and repetition to promote long-term adherence.
Nursing Education B+1
EXPERIMENTALArm: B + 1 Patients received medication education once. The session introduced phosphate binders, usage timing, and basic instructions for improving adherence.
Nursing Education B+2
EXPERIMENTALArm: B + 2 Patients received medication education twice. The intervention emphasized adherence barriers and strategies for taking binders correctly with meals.
Nursing Education B+3
EXPERIMENTALArm: B + 3 Patients received medication education three times. The sessions included repeated instruction, practical timing scenarios, and Q\&A with nursing staff.
Nursing Education AB+1
EXPERIMENTALArm: A+B + 1 Patients received combined dietary and medication education once. The session addressed both phosphorus intake from food and proper medication use.
Nursing Education AB+2
EXPERIMENTALArm: A+B + 2 Patients received combined dietary and medication education twice. The intervention highlighted food-drug interactions and provided dual-domain strategies.
Nursing Education AB+3
EXPERIMENTALArm: A+B + 3 Patients received combined dietary and medication education three times. The sessions offered integrated guidance, practice tools, and individualized plans.
Interventions
Combined dietary and medication education once
Combined dietary and medication education twice
Combined dietary and medication education three times
Eligibility Criteria
You may qualify if:
- Patients who have been on dialysis for more than one year, have intact self-awareness, and are currently taking phosphate-binding medications.
You may not qualify if:
- Patients who have been on dialysis for less than one year, lack self-awareness, or are not taking phosphate-lowering medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wei-Hua
Taichung, 412224, Taiwan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Jen-Ai Hospital Principal Investigator
Study Record Dates
First Submitted
June 18, 2025
First Posted
July 23, 2025
Study Start
July 29, 2024
Primary Completion
July 28, 2025
Study Completion
July 28, 2025
Last Updated
July 23, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share