Clinical trial NCT06221228: Flipped Classroom Approach in Continuous Ambulatory Peritoneal Dialysis Training
Official title: Flipped Classroom Approach in Continuous Ambulatory Peritoneal Dialysis Training: Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Continuous Ambulatory Peritoneal Dialysis Training
Pre-dialysis education programme
flipped class pedagoggy
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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, \&amp; Fraser, 2016). Eligibility for the study will be determined by the initial screening on the condition of the CKD.

Eligibility criteria: Inclusion Criteria:

The candidates should meet the below criteria will be recruited.

1. age ≥ 18 years
2. clinically diagnosed to have CKD Stage 5 (estimated creatinine clearance - 15 mL/min/1.73 m2)
3. Tenkoff insertion was performed and CAPD training will be offered in 4 weeks
4. able to perform self-care CAPD or family-assisted CAPD
5. willing to participate in audio-visual assisted and face-to-face activities
6. alert and oriented, able to sustain for approximately one hour of attention and interaction
7. communicable in Cantonese, able to read and write Chinese
8. could be reached by phone and able to use electronic devices, e.g. smart phone, tablet, notebook or computers to access online audio-visual materials

Exclusion Criteria:

Patients having one or above of the below conditions will be excluded from the study.

1. patients who have been receiving dialysis therapy
2. patients who are unable to communicate in Cantonese
3. patient who has hearing deficit
4. patient who are disoriented, delirious or cognitively impaired
5. patients who are clinically depressed diagnosed by medical doctors
6. patients who do not have access to online material using electronic devices
7. patients who are incompetent in giving written consent

Primary outcomes:
measure: Peritoneal Dialysis Psychomotor Skill Competency Checklist
timeFrame: 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.
Secondary outcomes:
measure: Student Satisfaction and Self-confidence in Learning (SSSCL) Inventory
timeFrame: Immediately post pre-dialysis training
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: School of Nursing, The Hong Kong Polytechnic University
state: Hong Kong Island
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Kitty Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: National League for Nursing. A vision for teaching with simulation: a living document from the National League for Nursing NLN Board of Governors. 2015. Retrieved from https://www.nln.org/docs/default-source/uploadedfiles/about/nln-vision-series-position-statements/vision-statement-a-vision-for-teaching-with-simulation.pdf?sfvrsn=e847da0d_0
citation: Chan JCK, Fong DYT, Tang JJ, Gay KP, & Hui J. The Chinese Student Satisfaction and Self-Confidence Scale Is reliable and valid. Clinical Simulation in Nursing. 2015; 11(5), 278-283. https://doi.org/10.1016/j.ecns.2015.03.003