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

Study Overview
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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.

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]

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

Conditions
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Renal Failure Chronic

Intervention / Treatment
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* Device: Helping Hands for CAPD bag exchange procedures


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-inferiority, Paralleled, Randomized Controlled Trial
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peritonitis Rate | 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 | 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 | 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 | 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 | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Ambulatory Peritoneal Dialysis