Peritoneal DialysisNCT06876987
The Mobile-based Training System in Peritoneal Dialysis Patients
A study testing Routine care and Retraining Program in people with Peritoneal Dialysis, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The mobile-based training system can effectively improve the knowledge and technical correctness of peritoneal dialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis
- What is being tested?
- Routine care and Retraining Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Mar 2025to 5 Mar 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have received peritoneal dialysis for more than 3 months; patients who have received peritoneal dialysis for less than 3 months but have recovered from peritonitis or catheter-related infection; patients who are conscious and have no mental illness.
Who cannot join
- Patients who are unable to perform peritoneal dialysis independently; illiterate; suffering from peritonitis or catheter exit site infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University
Taichung, 406040
Ya-Fang Ho, PhD, 886- 4-22967979 ext. 7108, avonho97@mail.cmu.edu.tw
Ya-Fang Ho, PhD
About this study
Official title: The Development and Evidence Effect of a Mobile-based Situational Simulation Peritoneal Dialysis Training System in the Retraining Program of Peritoneal Dialysis Patients
The mobile-based training system can effectively improve the knowledge and technical correctness of peritoneal dialysis patients.
Read the detailed description
Use mobile-based training system in peritoneal dialysis patients' retraining programs and continuously monitor the effectiveness.
- Conditions
- Peritoneal Dialysis
- Being tested
- Routine care, Retraining Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine careOther
Receiving routine care.
Retraining ProgramOther
Retraining program using a mobile-based training system.
| Study group | Role | What they receive |
|---|---|---|
| Routine care group | Active comparator | Receiving routine care. Receives: Other: Routine care |
| Retraining Program Group | Experimental | Retraining program using a mobile-based training system. Receives: Other: Retraining Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritoneal Dialysis Knowledge Scale
Knowledge issues related to peritoneal dialysis. The Peritoneal Dialysis Care Knowledge Questionnaire will include questions related to hand hygiene, peritoneal dialysis exchange procedures, catheter exit-site care, and knowledge about infections and peritonitis. The questionnaire consists of approximately 20 questions. Each correct answer is awarded 1 point, while incorrect answers receive 0 points, with a total score of 20 points. A higher score indicates better knowledge of peritoneal dialysis care among participants.
Measured: Immediately after recruitment, 1 month and 2 months after intervention
Peritoneal Dialysis Procedure Checklist
This scale is used to evaluate all steps involved in hand hygiene, peritoneal dialysis solution bag exchange, and catheter exit-site care. Each item is assessed with a "Yes" or "No" response, with a total of 25 items. Correct actions are awarded 1 point, while incorrect actions receive 0 points, for a maximum score of 25. Higher scores indicate better proficiency in peritoneal dialysis care-related techniques among participants.
Measured: Immediately after recruitment, 1 month and 2 months after intervention
Secondary outcomes (1)
Infection event rate
Infection event related to catheter exit care and peritonitis
Measured: 6 months after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start6 Mar 2025
- Primary completion5 Mar 2026 (estimated)
- Study completion5 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The peritoneal dialysis patients participating in the study were divided into an experimental group and a control group.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876987
- Sponsor's protocol ID
- CMUH112-REC3-075
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Evidence Effect of a Mobile-based Situational Simulation Peritoneal Dialysis Training System in the Retraining Program of Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT06876987
- Acronym / sponsor ID
- CMUH112-REC3-075
- Conditions
- Peritoneal Dialysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 5 Mar 2026 (estimated)
- Study completion
- 5 Mar 2026 (estimated)
- First posted
- 14 Mar 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.
The mobile-based training system can effectively improve the knowledge and technical correctness of peritoneal dialysis patients.
Detailed description
Use mobile-based training system in peritoneal dialysis patients' retraining programs and continuously monitor the effectiveness.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The peritoneal dialysis patients participating in the study were divided into an experimental group and a control group.
| Arm | Type | Receives |
|---|---|---|
| Routine care group | Active comparator | Other: Routine careReceiving routine care. |
| Retraining Program Group | Experimental | Other: Retraining ProgramRetraining program using a mobile-based training system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have received peritoneal dialysis for more than 3 months; patients who have received peritoneal dialysis for less than 3 months but have recovered from peritonitis or catheter-related infection; patients who are conscious and have no mental illness.
Key exclusion criteria (1 listed)
- Patients who are unable to perform peritoneal dialysis independently; illiterate; suffering from peritonitis or catheter exit site infection.
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 |
|---|---|---|
| Routine careReceiving routine care. | Other | Routine care group |
| Retraining ProgramRetraining program using a mobile-based training system. | Other | Retraining Program Group |
Primary outcome
Peritoneal Dialysis Knowledge Scale
Time frame: Immediately after recruitment, 1 month and 2 months after intervention
Knowledge issues related to peritoneal dialysis. The Peritoneal Dialysis Care Knowledge Questionnaire will include questions related to hand hygiene, peritoneal dialysis exchange procedures, catheter exit-site care, and knowledge about infections and peritonitis. The questionnaire consists of approximately 20 questions. Each correct answer is awarded 1 point, while incorrect answers receive 0 points, with a total score of 20 points. A higher score indicates better knowledge of peritoneal dialysis care among participants.
Peritoneal Dialysis Procedure Checklist
Time frame: Immediately after recruitment, 1 month and 2 months after intervention
This scale is used to evaluate all steps involved in hand hygiene, peritoneal dialysis solution bag exchange, and catheter exit-site care. Each item is assessed with a "Yes" or "No" response, with a total of 25 items. Correct actions are awarded 1 point, while incorrect actions receive 0 points, for a maximum score of 25. Higher scores indicate better proficiency in peritoneal dialysis care-related techniques among participants.
1 secondary outcome
Infection event rate
Time frame: 6 months after recruitment
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 14 Mar 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine care and Retraining Program in people with Peritoneal Dialysis, run by China Medical University Hospital 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: looking for participants now, as of the sponsor's last update on 14 Mar 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peritoneal Dialysis Knowledge Scale (time frame: Immediately after recruitment, 1 month and 2 months after intervention). The study lists 2 primary outcomes in all. 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 14 Mar 2025.