School of Nursing, The Hong Kong Polytechnic University
Hung Hom, Hong Kong Island, Hong Kong
Location contact
Kitty Chan, PhD
CONTACT
Suet Lai Tam
PRINCIPAL_INVESTIGATOR
Suet Lai Tam, Master
CONTACT
NCT Number: NCT06221228
The goal of this single-blinded randomized controlled trial is to evaluate the effectiveness of an educational intervention for patient self-management and successful renal replacement therapy in Chronic Kidney Disease (CKD) patients.
The main question it aims to answer is whether the flipped class pedagogy in delivering the pre-dialysis program to CKD patients is effective.
Participants will undergo a week-long intervention consisting of pre-class instructional videos, self-study tutorials, face-to-face sessions, and take-home exercises, and will be compared to those receiving the conventional educational course.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Hung Hom, Hong Kong Island, Hong Kong
Kitty Chan, PhD
CONTACT
Suet Lai Tam
PRINCIPAL_INVESTIGATOR
Suet Lai Tam, Master
CONTACT
The aim of this study is to examine the effectiveness of the flipped classroom approach in CAPD training for CKD patients who have to plan for receiving peritoneal dialysis therapy. Learning outcomes, adherence to therapy, occurrence of infections (episodes per patient-month) - exit site infection/tunnel infection, and PD-related peritonitis will be investigated. The ClinicalTrials.gov Identifier of this study will be applied.
Design and Randomisation This study is a single-blinded randomised controlled trial in a single centre. On completion of the baseline assessment and the screening procedure, eligible participants will be randomly assigned in equal number using sets of computer-generated random numbers into either the experimental group - FC training with audio-visual aids and the control group - Conventional Training (CT). The principal investigator and the nurse providing the intervention are aware of the patient group assignment. Assessment of the baseline and endpoints of the patient outcomes will be performed by an independent research assistant blinded to group allocation, who was not involved in the intervention. Figure 1 presented the data collection using the Consolidated Standards of Reporting Trials (CONSORT), which will be done before the commencement of the intervention (T1), immediately post-intervention (T2) and one month (T3) and three months (T4) after the completion of programme.
Participants and Study setting Patients attending the outpatient renal clinic of a Kwong Wah Hospital in Hong Kong will be approached. Stage 5 CKD patients who are planned to receive dialysis therapy will be invited to join the study. Comorbidity will not be considered in client selection since research suggested that it only explains a modest part of the variance of patient outcome in a multicenter study on CKD patients (Steenkamp, Rao, & Fraser, 2016). Eligibility for the study will be determined by the initial screening on the condition of the CKD.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The candidates should meet the below criteria will be recruited.
Exclusion criteria
Patients having one or above of the below conditions will be excluded from the study.
FC CAPD programme is a one-week individual intervention, which consists of five sessions (8-hours each).
Pre-class audio-visual tutorials will be provided for self-study prior to face-to-face (F2F) sessions. Six instructional videos, each dedicated to a specific procedure, are accessible for preview and repeated viewing as needed. Such flexibility allows the patients to revise at their own preferred time and pace.
Participants will be asked to take note of any issues or difficulties they encounter while watching the video.
A CAPD education booklet will be prepared and distributed to the patients at the beginning of the F2F training session.
Take-home exercises will allow participants to revise the materials covered in the videos and consolidate their learning.
Time frame: Baseline assessment will be conducted prior to the intervention (T1), immediately post-intervention (T2) and one month (T3) and three months (T4) after the completion of programme.
Patients' performance will be evaluated to see whether these are safe based on the competency checklist on peritoneal dialysis fluid exchange skills and exit site management, and the Multiple choice questions (MCQs) will be used to test the relevant knowledge.
This assessment tool is validated by the expert panel of five members including one nephrologist, two renal nurse clinicians, and two academic staff.
Time frame: Immediately post pre-dialysis training
Satisfaction of the pre-dialysis programme will be measured by the Student Satisfaction and Self-Confidence in Learning (SSSCL) inventory (National League for Nursing, 2015, Chan, Fong, Tang, Gay, & Hui, 2015) to determine the satisfaction of the teaching method and self-confidence in mastering the content and skill (Cronbach's alpha from 0.87 to 0.94).
The two subscales student satisfaction (5-items) and self-confidence (8 items) will be rated on a 5-point Likert scale scoring from strongly disagree (1) to strongly agree (5). The higher the sum scores indicate better satisfaction and self-confidence.
Contact information is provided by the study sponsor or research team.
Kitty Chan, PhD
CONTACT
Suet Lai Tam
CONTACT
The Hong Kong Polytechnic University
Other
Flipped Classroom Approach in Continuous Ambulatory Peritoneal Dialysis Training: Protocol
Acronym: FCCAPD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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