Nursing EducationNCT07080840
Phosphorus Education and Adherence in Hemodialysis Patients
A study testing Nursing education A+1, Nursing education A+2 and Nursing education A+3 in people with Nursing Education and Hemodialysis, run by Jen-Ai Hospital Institutional Review Board at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nursing Education, Hemodialysis
- What is being tested?
- Nursing education A+1, Nursing education A+2 and Nursing education A+3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Jul 2024to 28 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who have been on dialysis for more than one year, have intact self-awareness, and are currently taking phosphate-binding medications.
Who cannot join
- Patients who have been on dialysis for less than one year, lack self-awareness, or are not taking phosphate-lowering medications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Adherence as a Moderator of Phosphorus Education Effectiveness in Hemodialysis Patients: an Exploratory Study
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.
- Conditions
- Nursing Education, Hemodialysis
- Being tested
- Nursing education A+1, Nursing education A+2, Nursing education A+3, Nursing education B+1, Nursing education B+2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing education A+1Behavioural
Dietary education once
Nursing education A+2Behavioural
Dietary education twice
Nursing education A+3Behavioural
Dietary education three times
Nursing education B+1Behavioural
Medication education once
Nursing education B+2Behavioural
Medication education twice
Nursing education B+3Behavioural
Medication education three times
Nursing education AB+1Behavioural
Combined dietary and medication education once
Nursing education AB+2Behavioural
Combined dietary and medication education twice
Nursing education AB+3Behavioural
Combined dietary and medication education three times
| Study group | Role | What they receive |
|---|---|---|
| Nursing Education A+1 | Experimental | Arm: A + 1 Patients received dietary education once. The session focused on phosphorus-rich food identification, dietary restrictions, and basic meal planning. Receives: Behavioral: Nursing education A+1 |
| Nursing Education A+2 | Experimental | Arm: A + 2 Patients received dietary education twice. The program reinforced dietary knowledge through interactive review and provided individual nutrition tips. Receives: Behavioral: Nursing education A+2 |
| Nursing Education A+3 | Experimental | Arm: A + 3 Patients received dietary education three times. Sessions included detailed meal planning, food label reading, and repetition to promote long-term adherence. Receives: Behavioral: Nursing education A+3 |
| Nursing Education B+1 | Experimental | Arm: B + 1 Patients received medication education once. The session introduced phosphate binders, usage timing, and basic instructions for improving adherence. Receives: Behavioral: Nursing education B+1 |
| Nursing Education B+2 | Experimental | Arm: B + 2 Patients received medication education twice. The intervention emphasized adherence barriers and strategies for taking binders correctly with meals. Receives: Behavioral: Nursing education B+2 |
| Nursing Education B+3 | Experimental | Arm: B + 3 Patients received medication education three times. The sessions included repeated instruction, practical timing scenarios, and Q\&A with nursing staff. Receives: Behavioral: Nursing education B+3 |
| Nursing Education AB+1 | Experimental | Arm: A+B + 1 Patients received combined dietary and medication education once. The session addressed both phosphorus intake from food and proper medication use. Receives: Behavioral: Nursing education AB+1 |
| Nursing Education AB+2 | Experimental | Arm: A+B + 2 Patients received combined dietary and medication education twice. The intervention highlighted food-drug interactions and provided dual-domain strategies. Receives: Behavioral: Nursing education AB+2 |
| Nursing Education AB+3 | Experimental | Arm: A+B + 3 Patients received combined dietary and medication education three times. The sessions offered integrated guidance, practice tools, and individualized plans. Receives: Behavioral: Nursing education AB+3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and every 2 weeks until Week 12 (August 19 to November 4, 2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start29 Jul 2024
- Primary completion28 Jul 2025 (estimated)
- Study completion28 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jen-Ai Hospital Institutional Review Board
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Ming-Chih Chang, Jen-Ai Hospital Institutional Review Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080840
- Sponsor's protocol ID
- WHChen
- Status last verified
- Jul 2025
- First submitted
- 18 Jun 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence as a Moderator of Phosphorus Education Effectiveness in Hemodialysis Patients: an Exploratory Study
- ClinicalTrials.gov ID
- NCT07080840
- Acronym / sponsor ID
- WHChen
- Conditions
- Nursing Education, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Jen-Ai Hospital Institutional Review BoardIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 28 Jul 2025 (estimated)
- Study completion
- 28 Jul 2025 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Nursing Education A+1 | Experimental | Behavioral: Nursing education A+1Arm: 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 | Experimental | Behavioral: Nursing education A+2Arm: A + 2 Patients received dietary education twice. The program reinforced dietary knowledge through interactive review and provided individual nutrition tips. |
| Nursing Education A+3 | Experimental | Behavioral: Nursing education A+3Arm: 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 | Experimental | Behavioral: Nursing education B+1Arm: B + 1 Patients received medication education once. The session introduced phosphate binders, usage timing, and basic instructions for improving adherence. |
| Nursing Education B+2 | Experimental | Behavioral: Nursing education B+2Arm: B + 2 Patients received medication education twice. The intervention emphasized adherence barriers and strategies for taking binders correctly with meals. |
| Nursing Education B+3 | Experimental | Behavioral: Nursing education B+3Arm: 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 | Experimental | Behavioral: Nursing education AB+1Arm: 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 | Experimental | Behavioral: Nursing education AB+2Arm: 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 | Experimental | Behavioral: Nursing education AB+3Arm: A+B + 3 Patients received combined dietary and medication education three times. The sessions offered integrated guidance, practice tools, and individualized plans. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have been on dialysis for more than one year, have intact self-awareness, and are currently taking phosphate-binding medications.
Key exclusion criteria (1 listed)
- Patients who have been on dialysis for less than one year, lack self-awareness, or are not taking phosphate-lowering medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing education A+1Dietary education once | Behavioural | Nursing Education A+1 |
| Nursing education A+2Dietary education twice | Behavioural | Nursing Education A+2 |
| Nursing education A+3Dietary education three times | Behavioural | Nursing Education A+3 |
| Nursing education B+1Medication education once | Behavioural | Nursing Education B+1 |
| Nursing education B+2Medication education twice | Behavioural | Nursing Education B+2 |
| Nursing education B+3Medication education three times | Behavioural | Nursing Education B+3 |
| Nursing education AB+1Combined dietary and medication education once | Behavioural | Nursing Education AB+1 |
| Nursing education AB+2Combined dietary and medication education twice | Behavioural | Nursing Education AB+2 |
| Nursing education AB+3Combined dietary and medication education three times | Behavioural | Nursing Education AB+3 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing education A+1, Nursing education A+2 and Nursing education A+3 in people with Nursing Education and Hemodialysis, run by Jen-Ai Hospital Institutional Review Board at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
phosphate (time frame: Baseline and every 2 weeks until Week 12 (August 19 to November 4, 2025)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.