Randomized Controlled Trial on 3D Printed Assistive Device for Continuous Ambulatory Peritoneal Dialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-12-31

Brief Summary

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Touch contamination during bag exchange in Continuous Ambulatory Peritoneal Dialysis (CAPD) is a common cause of CAPD-related peritonitis. An innovative 3D-printed assistive device "Helping Hands" was designed to minimize direct touch of tubing during CAPD bag exchange to allow a safer connection process for patients with Chronic Kidney Disease (CKD) to reduce the risk of CAPD-related peritonitis. Through this randomized control, the investigators aimed to evaluate the safety and efficacy of "Helping Hands" in CAPD bag exchange procedure for patients on CAPD therapy.

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Detailed Description

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The study will be conducted in the Renal Unit, Queen Elizabeth Hospital (QEH). All new CAPD patients using Ultrabag Peritoneal Dialysis (PD) system will be screened and invited to participate in this study by occupational therapist or nurse. Patients with cognitive impairment, psychiatric illness, acute illness that requires frequent hospital admissions (\>3 episodes with hospital stay over 1 week), or current adoption of other type of assistive device in CAPD bag exchange will be excluded. Eligible patients will be randomly allocated to either intervention group (using "Helping Hands") or control group. Participants in both arms will receive a standard 5-day CAPD training program and then perform a competency test for bag exchange conducted by an independent Advanced Practice Nurses. Irrespective of grouping, participants will receive brief phone interviews by clerks (who did not take the role as investigators) from the QEH Renal Unit with two sets of questionnaire measuring their health related conditions at 4 time points i) A0 (baseline); ii) A1 (last day of CAPD training); iii) A2 (4-month post-training follow-up); and iv) A3 (8-month post-training follow-up). Intervention group will receive additional training on using "Helping Hands" as assistive device in performing bag exchange and will have extra follow-up assessment at the 4th and 8th month post-training to ensure their competence in using "Helping Hands" device to perform CAPD exchanges. Relevant clinical data, such as peritonitis record, will be collected during their routine follow-up in the dialysis center or by clinical medical system.

This is a non-inferiority study with the objective of establishing the safety and efficacy of "Helping hands" device for patients doing CAPD bag exchanges using UltraBag PD system. Primary outcome of the study is CAPD peritonitis rate and transfer set contamination rate between the two groups. The secondary outcomes are overall health conditions measured by two sets of standardized and reliable questionnaires: The short-form General Health Questionnaire (SF-36, Chinese version) and Depressive Anxiety Stress Scales (DASS-21, Chinese version).

\[May refer to sessions of "Outcome measures" and "Eligibility" for details\]

Conditions

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Renal Failure Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Non-inferiority, Paralleled, Randomized Controlled Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

After completion of written consent, participants were randomly assigned to either intervention or control group. Outcomes assessors (and facilitators for phone interview for follow-up action) were independent, not knowing the condition of participants.

Study Groups

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Intervention Group

Training + "Helping Hands" provided for CAPD bag exchange procedures at home

Group Type EXPERIMENTAL

"Helping Hands" for CAPD bag exchange procedures

Intervention Type DEVICE

Training served as "Treatment As Usual" (TAU) for all participants; The difference between two groups was whether "Helping hands" were provided to participants for CAPD bag exchange procedures at home.

Control Group

Training alone (without "Helping Hands" provided to assist in bag exchange procedures)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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"Helping Hands" for CAPD bag exchange procedures

Training served as "Treatment As Usual" (TAU) for all participants; The difference between two groups was whether "Helping hands" were provided to participants for CAPD bag exchange procedures at home.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Newly commenced CAPD patient in QEH
* Chose Ultrabag as PD system
* Planned to perform CAPD bag exchange by own
* Being assessed and categorized as "High to Moderate Readiness" to perform CAPD by Occupational Therapist
* Able to understand Cantonese, Putonghua or English

Exclusion Criteria

* Severe cognitively impaired, aphasia, or suffer from psychiatric illness (e.g., unable to communicate effectively and understand the bag exchange procedure)
* old age home residents
* suffer from acute illness other than uremic syndromes requiring frequent hospital admission in the past 1 year (\> 3 episodes with hospital stay over 1 week)
* adopt other assistive device in CAPD bag exchange procedure prescribed by Occupational Therapist

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No