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

August 29, 2022 updated by: Carina Ho, Queen Elizabeth Hospital, Hong Kong

Efficacy and Safety of "Helping Hands": A 3D Printed Device of Peritoneal Dialysis Adopted in Continuous Ambulatory Peritoneal Dialysis: A Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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]

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Carina HO, APN(Renal)
  • Phone Number: 6506 852-3506
  • Email: hkm320@ha.org.hk

Study Contact Backup

  • Name: Victor CHEUNG, EOII(MDSSC)
  • Phone Number: 8773 852-3506
  • Email: ckl414@ha.org.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 852
        • Recruiting
        • Renal Unit, Department of Medicine, QEH
        • Contact:
        • Principal Investigator:
          • Carina HO, APN(Renal)
        • Sub-Investigator:
          • W L CHAK, CON(MED)
        • Sub-Investigator:
          • Y H CHAN, CON(MED)
        • Sub-Investigator:
          • Dorothy SUNG, NC(Renal)
        • Sub-Investigator:
          • George NG, CON(ICU)
        • Sub-Investigator:
          • S S SO, M(MDSSC)
        • Sub-Investigator:
          • Tiffany CHUNG, EAI(MDSSC)
        • Sub-Investigator:
          • Victor CHEUNG, EOII(MDSSC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Training + "Helping Hands" provided for CAPD bag exchange procedures at home
Device: "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.
No Intervention: Control Group
Training alone (without "Helping Hands" provided to assist in bag exchange procedures)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peritonitis Rate
Time Frame: From the date of randomization until the end of the study (1 year post-training follow-up) or date of drop-out (e.g., peritonitis, death, refusal to participate in the study... etc) whichever came earlier, assessed up to 36 months.
Peritonitis rate, in episodes per patient-year, as calculated by record of episodes of peritonitis and total number of patient months. Stratification of this outcome measure into intervention/ control arm for survival analysis could represent device safety.
From the date of randomization until the end of the study (1 year post-training follow-up) or date of drop-out (e.g., peritonitis, death, refusal to participate in the study... etc) whichever came earlier, assessed up to 36 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Scores
Time Frame: Through study completion, an average of 9 months at 4 timepoints: A0 (baseline), A1 (up to 1 month from recruitment to scheduled training session, and recorded at the end of the 1-week training), A2 (4-month post-training), A3 (8-month post-training).
Health Scores as measured by short-form General Health Questionnaire (SF-36, Chinese version) which consisted of i) physical functioning, ii) role limitations due to physical health, iii) role limitations due to emotional problems, iv) energy/ fatigue, v) emotional well-being, vi) social functioning, vii) pain, and viii) general health with scores ranging from 0 (the worst) to 100 (the best).
Through study completion, an average of 9 months at 4 timepoints: A0 (baseline), A1 (up to 1 month from recruitment to scheduled training session, and recorded at the end of the 1-week training), A2 (4-month post-training), A3 (8-month post-training).
Depressive Level
Time Frame: Through study completion, an average of 9 months at 4 timepoints: A0 (baseline), A1 (up to 1 month from recruitment to scheduled training session, and recorded at the end of the 1-week training), A2 (4-month post-training), A3 (8-month post-training).
Depressive Level as assessed by the short-form Depressive Anxiety Stress Scales (DASS-21, Chinese version). Of 21 questions in DASS-21, 7 were extracted to calculate a sub-total score of the depression level, ranging from 0 to 21 (Normal = 0 - 4; Mild = 5 - 6; Moderate = 7 - 10; Severe = 11 - 13; Extremely Severe = 14 - 21).
Through study completion, an average of 9 months at 4 timepoints: A0 (baseline), A1 (up to 1 month from recruitment to scheduled training session, and recorded at the end of the 1-week training), A2 (4-month post-training), A3 (8-month post-training).
Anxiety Level
Time Frame: Through study completion, an average of 9 months at 4 timepoints: A0 (baseline), A1 (up to 1 month from recruitment to scheduled training session, and recorded at the end of the 1-week training), A2 (4-month post-training), A3 (8-month post-training).
Anxiety Level as assessed by the short-form Depressive Anxiety Stress Scales (DASS-21, Chinese version). Of 21 questions in DASS-21, 7 were extracted to calculate a sub-total score of the anxiety level, ranging from 0 to 21 (Normal = 0 - 3; Mild = 4 - 5; Moderate = 6 - 7; Severe = 8 - 9; Extremely Severe = 10 - 21).
Through study completion, an average of 9 months at 4 timepoints: A0 (baseline), A1 (up to 1 month from recruitment to scheduled training session, and recorded at the end of the 1-week training), A2 (4-month post-training), A3 (8-month post-training).
Stress Level
Time Frame: Through study completion, an average of 9 months at 4 timepoints: A0 (baseline), A1 (up to 1 month from recruitment to scheduled training session, and recorded at the end of the 1-week training), A2 (4-month post-training), A3 (8-month post-training).
Stress Level as assessed by the short-form Depressive Anxiety Stress Scales (DASS-21, Chinese version). Of 21 questions in DASS-21, 7 were extracted to calculate a sub-total score of the stress level, ranging from 0 to 21 (Normal = 0 - 7; Mild = 8 - 9; Moderate = 10 - 12; Severe = 13 - 16; Extremely Severe = 17 - 21).
Through study completion, an average of 9 months at 4 timepoints: A0 (baseline), A1 (up to 1 month from recruitment to scheduled training session, and recorded at the end of the 1-week training), A2 (4-month post-training), A3 (8-month post-training).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Basic Knowledge Acquisition
Time Frame: Through the timepoint of training completion, an average of 5 weeks at 1 timepoint: A1 (at the end of the 1-week training following recruitment and scheduling time up to 1 month).
Basic knowledge acquisition level as assessed by Knowledge Evaluation Index (KEI), a verbal exam to evaluate the degree to which participants acquire renal disease related knowledge, CAPD complications and exit site care on cognitive domain. KEI scores ranged from 0 to 100% (full mark; pass at 50%).
Through the timepoint of training completion, an average of 5 weeks at 1 timepoint: A1 (at the end of the 1-week training following recruitment and scheduling time up to 1 month).
CAPD Performance
Time Frame: Through the timepoint of training completion, an average of 5 weeks at 1 timepoint: A1 (at the end of the 1-week training following recruitment and scheduling time up to 1 month).
CAPD-specific skills acquisition as assessed by a practical summative assessment which evaluates hands-on skill acquisition of participants at the end of the training. Either Pass (perform entire procedures in correct order by self) or Fail (unable to complete all steps in correct order) will be determined on assessment.
Through the timepoint of training completion, an average of 5 weeks at 1 timepoint: A1 (at the end of the 1-week training following recruitment and scheduling time up to 1 month).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Elizabeth Hospital, Hong Kong

Investigators

  • Principal Investigator: Carina HO, APN(Renal), Renal Unit, Queen Elizabeth Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

August 26, 2022

First Posted (Actual)

August 30, 2022

Study Record Updates

Last Update Posted (Actual)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-0266-FR-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Failure Chronic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe