NCT06221228

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Sep 2024Sep 2026

First Submitted

Initial submission to the registry

December 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

January 24, 2024

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

December 20, 2023

Last Update Submit

January 14, 2024

Conditions

Keywords

Continuous Ambulatory Peritoneal Dialysis TrainingPre-dialysis education programmeflipped class pedagoggy

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Immediately post pre-dialysis training

Study Arms (2)

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.

Behavioral: Audio-visual assisted Flipped Classroom (FC) CAPD Training Programme

Interventions

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.

Audio-visual assisted Flipped Classroom pre-dialysis training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic University

Hung Hom, Hong Kong Island, Hong Kong

Location

Related Publications (2)

  • 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

    BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kitty Chan, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2023

First Posted

January 24, 2024

Study Start

September 1, 2024

Primary Completion

September 1, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

January 24, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

future multi-sites studies may be implemented, and once this is completed, and paper published, we are happy to share the IPD.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
When the project is completed and publication available
Access Criteria
access by sending email to the corresponding author

Locations