- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06876987
The Mobile-based Training System in Peritoneal Dialysis Patients
March 13, 2025 updated by: China Medical University Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Use mobile-based training system in peritoneal dialysis patients' retraining programs and continuously monitor the effectiveness.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taichung, Taiwan, 406040
- Recruiting
- China Medical University
-
Contact:
- Ya-Fang Ho, PhD
- Phone Number: 7108 886- 4-22967979
- Email: avonho97@mail.cmu.edu.tw
-
Principal Investigator:
- Ya-Fang Ho, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who are unable to perform peritoneal dialysis independently; illiterate; suffering from peritonitis or catheter exit site infection.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Routine care group
Receiving routine care.
|
Receiving routine care.
|
|
Experimental: Retraining Program Group
Retraining program using a mobile-based training system.
|
Retraining program using a mobile-based training system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Immediately after recruitment, 1 month and 2 months after intervention
|
|
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.
|
Immediately after recruitment, 1 month and 2 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Infection event rate
Time Frame: 6 months after recruitment
|
Infection event related to catheter exit care and peritonitis
|
6 months after recruitment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 6, 2025
Primary Completion (Estimated)
March 5, 2026
Study Completion (Estimated)
March 5, 2026
Study Registration Dates
First Submitted
March 6, 2025
First Submitted That Met QC Criteria
March 13, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 13, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- CMUH112-REC3-075
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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