Phosphorus Education and Adherence in Hemodialysis Patients

NCT ID: NCT07080840

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-29

Study Completion Date

2025-07-28

Brief Summary

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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.

Detailed Description

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Conditions

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Nursing Education Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Nursing education A+1

Intervention Type BEHAVIORAL

Dietary education once

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.

Group Type EXPERIMENTAL

Nursing education A+2

Intervention Type BEHAVIORAL

Dietary education twice

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.

Group Type EXPERIMENTAL

Nursing education A+3

Intervention Type BEHAVIORAL

Dietary education three times

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.

Group Type EXPERIMENTAL

Nursing education B+1

Intervention Type BEHAVIORAL

Medication education once

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.

Group Type EXPERIMENTAL

Nursing education B+2

Intervention Type BEHAVIORAL

Medication education twice

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.

Group Type EXPERIMENTAL

Nursing education B+3

Intervention Type BEHAVIORAL

Medication education three times

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.

Group Type EXPERIMENTAL

Nursing education AB+1

Intervention Type BEHAVIORAL

Combined dietary and medication education once

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.

Group Type EXPERIMENTAL

Nursing education AB+2

Intervention Type BEHAVIORAL

Combined dietary and medication education twice

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.

Group Type EXPERIMENTAL

Nursing education AB+3

Intervention Type BEHAVIORAL

Combined dietary and medication education three times

Interventions

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Nursing education A+1

Dietary education once

Intervention Type BEHAVIORAL

Nursing education A+2

Dietary education twice

Intervention Type BEHAVIORAL

Nursing education A+3

Dietary education three times

Intervention Type BEHAVIORAL

Nursing education B+1

Medication education once

Intervention Type BEHAVIORAL

Nursing education B+2

Medication education twice

Intervention Type BEHAVIORAL

Nursing education B+3

Medication education three times

Intervention Type BEHAVIORAL

Nursing education AB+1

Combined dietary and medication education once

Intervention Type BEHAVIORAL

Nursing education AB+2

Combined dietary and medication education twice

Intervention Type BEHAVIORAL

Nursing education AB+3

Combined dietary and medication education three times

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jen-Ai Hospital Institutional Review Board

INDUSTRY

Sponsor Role lead

Responsible Party

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Ming-Chih Chang

Jen-Ai Hospital Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wei-Hua

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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WHChen

Identifier Type: -

Identifier Source: org_study_id

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