Chronic Kidney DiseaseFCCAPDNCT06221228
Flipped Classroom Approach in Continuous Ambulatory Peritoneal Dialysis Training
A study testing Audio-visual assisted Flipped Classroom (FC) CAPD Training Programme in people with Chronic Kidney Disease, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Audio-visual assisted Flipped Classroom (FC) CAPD Training Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2024to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- The candidates should meet the below criteria will be recruited.
- age ≥ 18 years
- clinically diagnosed to have CKD Stage 5 (estimated creatinine clearance - 15 mL/min/1.73 m2)
- Tenkoff insertion was performed and CAPD training will be offered in 4 weeks
- able to perform self-care CAPD or family-assisted CAPD
- willing to participate in audio-visual assisted and face-to-face activities
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- alert and oriented, able to sustain for approximately one hour of attention and interaction
- communicable in Cantonese, able to read and write Chinese
- 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
Who cannot join
- Patients having one or above of the below conditions will be excluded from the study.
- patients who have been receiving dialysis therapy
- patients who are unable to communicate in Cantonese
- patient who has hearing deficit
- patient who are disoriented, delirious or cognitively impaired
- patients who are clinically depressed diagnosed by medical doctors
- patients who do not have access to online material using electronic devices
- patients who are incompetent in giving written consent
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Nursing, The Hong Kong Polytechnic University
Hung Hom, Hong Kong Island
Kitty Chan, PhD, 852-27666883, kitty.yy.chan@polyu.edu.hk
Suet Lai Tam, Master, 852-35177400, tamsl@ha.org.hk
About this study
Official title: Flipped Classroom Approach in Continuous Ambulatory Peritoneal Dialysis Training: Protocol
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.
Read the 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, \& Fraser, 2016). Eligibility for the study will be determined by the initial screening on the condition of the CKD.
- Conditions
- Chronic Kidney Disease
- Being tested
- Audio-visual assisted Flipped Classroom (FC) CAPD Training Programme
- Keywords
- Continuous Ambulatory Peritoneal Dialysis Training, Pre-dialysis education programme, flipped class pedagoggy
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio-visual assisted Flipped Classroom (FC) CAPD Training ProgrammeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Training (CT): | No intervention | Usual care in the clinical practice: Pre-dialysis training class |
| Audio-visual assisted Flipped Classroom pre-dialysis training | Experimental | The audio-visual assisted Flipped Classroom (FC) CAPD Training 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 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. The four videos are (1) CAPD preparation and hand washing, (2) CAPD bag exchange procedure (Ultrabag or Balance systems), (3) Trouble shooting, and (4) Addressing contamination, (5) Detecting peritonitis, and (6) Exit site care. 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. Receives: Behavioral: Audio-visual assisted Flipped Classroom (FC) CAPD Training Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritoneal Dialysis Psychomotor Skill Competency Checklist
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.
Measured: 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 (1)
Student Satisfaction and Self-confidence in Learning (SSSCL) Inventory
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.
Measured: Immediately post pre-dialysis training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kitty Chan, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221228
- Sponsor's protocol ID
- HSEARS20230905003
- Acronym
- FCCAPD
- Status last verified
- Nov 2023
- First submitted
- 20 Dec 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: future multi-sites studies may be implemented, and once this is completed, and paper published, we are happy to share the IPD.
Publications
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
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flipped Classroom Approach in Continuous Ambulatory Peritoneal Dialysis Training: Protocol
- ClinicalTrials.gov ID
- NCT06221228
- Acronym / sponsor ID
- FCCAPD / HSEARS20230905003
- Conditions
- Chronic Kidney Disease
- Keywords
- Continuous Ambulatory Peritoneal Dialysis Training, Pre-dialysis education programme, flipped class pedagoggy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 24 Jan 2024 (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 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, \& Fraser, 2016). Eligibility for the study will be determined by the initial screening on the condition of the CKD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Training (CT): | No intervention | –Usual care in the clinical practice: Pre-dialysis training class |
| Audio-visual assisted Flipped Classroom pre-dialysis training | Experimental | Behavioral: Audio-visual assisted Flipped Classroom (FC) CAPD Training ProgrammeThe audio-visual assisted Flipped Classroom (FC) CAPD Training 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 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. The four videos are (1) CAPD preparation and hand washing, (2) CAPD bag exchange procedure (Ultrabag or Balance systems), (3) Trouble shooting, and (4) Addressing contamination, (5) Detecting peritonitis, and (6) Exit site care. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The candidates should meet the below criteria will be recruited.
- age ≥ 18 years
- clinically diagnosed to have CKD Stage 5 (estimated creatinine clearance - 15 mL/min/1.73 m2)
- Tenkoff insertion was performed and CAPD training will be offered in 4 weeks
- able to perform self-care CAPD or family-assisted CAPD
Key exclusion criteria (8 listed)
- Patients having one or above of the below conditions will be excluded from the study.
- patients who have been receiving dialysis therapy
- patients who are unable to communicate in Cantonese
- patient who has hearing deficit
- patient who are disoriented, delirious or cognitively impaired
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 |
|---|---|---|
| Audio-visual assisted Flipped Classroom (FC) CAPD Training ProgrammeFC 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. | Behavioural | Audio-visual assisted Flipped Classroom pre-dialysis training |
Primary outcome
Peritoneal Dialysis Psychomotor Skill Competency Checklist
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.
1 secondary outcome
Student Satisfaction and Self-confidence in Learning (SSSCL) Inventory
Time frame: Immediately post pre-dialysis training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- BackgroundNational 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
- BackgroundChan 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
- Individual participant dataSharing planned: Yes. future multi-sites studies may be implemented, and once this is completed, and paper published, we are happy to share the IPD.
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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. This study is not recruiting at the moment.
Kitty Chan, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audio-visual assisted Flipped Classroom (FC) CAPD Training Programme in people with Chronic Kidney Disease, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 24 Jan 2024. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kitty Chan, PhD (852-9168322, kitty.yy.chan@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peritoneal Dialysis Psychomotor Skill Competency Checklist (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06221228, which also lists 2 linked publications.
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 24 Jan 2024.