CClinicalTrials.gg
Enrolling by invitationNCT07080840Updated Jul 23, 2025

Phosphorus Education and Adherence in Hemodialysis Patients

An interventional study of Nursing education A+1 and Nursing education A+2 in Nursing Education and Hemodialysis, sponsored by Jen-Ai Hospital Institutional Review Board. Enrolling by invitation at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2025-07-23.

Sponsored by Jen-Ai Hospital Institutional Review Board · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 2 months ago, but the record still lists the study as enrolling by invitation.
  • Registered 10 months after the study started (first participant enrolled Jul 2024, registered Jun 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Nursing Education
  • Hemodialysis
03

In context

Lead sponsor

Jen-Ai Hospital Institutional Review Board is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Patients who have been on dialysis for less than one year, lack self-awareness, or are not taking phosphate-lowering medications.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Nursing Education A+1

    Arm: A + 1 Patients received dietary education once. The session focused on phosphorus-rich food identification, dietary restrictions, and basic meal planning.

    Behavioral: Nursing education A+1

  • Experimental
    Nursing Education A+2

    Arm: A + 2 Patients received dietary education twice. The program reinforced dietary knowledge through interactive review and provided individual nutrition tips.

    Behavioral: Nursing education A+2

  • Experimental
    Nursing Education A+3

    Arm: A + 3 Patients received dietary education three times. Sessions included detailed meal planning, food label reading, and repetition to promote long-term adherence.

    Behavioral: Nursing education A+3

  • Experimental
    Nursing Education B+1

    Arm: B + 1 Patients received medication education once. The session introduced phosphate binders, usage timing, and basic instructions for improving adherence.

    Behavioral: Nursing education B+1

  • Experimental
    Nursing Education B+2

    Arm: B + 2 Patients received medication education twice. The intervention emphasized adherence barriers and strategies for taking binders correctly with meals.

    Behavioral: Nursing education B+2

  • Experimental
    Nursing Education B+3

    Arm: B + 3 Patients received medication education three times. The sessions included repeated instruction, practical timing scenarios, and Q\&A with nursing staff.

    Behavioral: Nursing education B+3

  • Experimental
    Nursing Education AB+1

    Arm: A+B + 1 Patients received combined dietary and medication education once. The session addressed both phosphorus intake from food and proper medication use.

    Behavioral: Nursing education AB+1

  • Experimental
    Nursing Education AB+2

    Arm: A+B + 2 Patients received combined dietary and medication education twice. The intervention highlighted food-drug interactions and provided dual-domain strategies.

    Behavioral: Nursing education AB+2

  • Experimental
    Nursing Education AB+3

    Arm: A+B + 3 Patients received combined dietary and medication education three times. The sessions offered integrated guidance, practice tools, and individualized plans.

    Behavioral: Nursing education AB+3

Interventions

  • BehavioralNursing education A+1

    Dietary education once

  • BehavioralNursing education A+2

    Dietary education twice

  • BehavioralNursing education A+3

    Dietary education three times

  • BehavioralNursing education B+1

    Medication education once

  • BehavioralNursing education B+2

    Medication education twice

  • BehavioralNursing education B+3

    Medication education three times

  • BehavioralNursing education AB+1

    Combined dietary and medication education once

  • BehavioralNursing education AB+2

    Combined dietary and medication education twice

  • BehavioralNursing education AB+3

    Combined dietary and medication education three times

06

What researchers measure

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.

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

07

Study locations

1 site
  • Wei-Hua
    Taichung, 412224, Taiwan
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 29, 2024
  • Informed consent form · Jul 29, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07080840
Lead sponsor
Jen-Ai Hospital Institutional Review Board
Responsible party
Ming-Chih Chang (Jen-Ai Hospital Principal Investigator, Jen-Ai Hospital Institutional Review Board) — Principal investigator
First posted
Jul 23, 2025
Start date
Jul 29, 2024
Primary completion
Jul 28, 2025 (estimated)
Completion
Jul 28, 2025 (estimated)
Last update
Jul 23, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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