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Flipped Classroom Approach in Continuous Ambulatory Peritoneal Dialysis Training (FCCAPD)

T

The Hong Kong Polytechnic University

Status

Begins enrollment in 1 month

Conditions

Chronic Kidney Disease

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06221228
HSEARS20230905003

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Conventional Training (CT):
No Intervention group
Description:
Usual care in the clinical practice: Pre-dialysis training class
Audio-visual assisted Flipped Classroom pre-dialysis training
Experimental group
Description:
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.
Treatment:
Behavioral: Audio-visual assisted Flipped Classroom (FC) CAPD Training Programme

Trial contacts and locations

1

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Central trial contact

Suet Lai Tam; Kitty Chan, PhD

Data sourced from clinicaltrials.gov

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