Clinical trial NCT05521425: Randomized Controlled Trial on 3D Printed Assistive Device for Continuous Ambulatory Peritoneal Dialysis
Official title: Efficacy and Safety of "Helping Hands": A 3D Printed Device of Peritoneal Dialysis Adopted in Continuous Ambulatory Peritoneal Dialysis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Failure Chronic
Keywords: Continuous Ambulatory Peritoneal Dialysis
Lead sponsor: Queen Elizabeth Hospital, Hong Kong
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority, Paralleled, Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: 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: 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).

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

Eligibility criteria: 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

Primary outcomes:
measure: Peritonitis Rate
timeFrame: 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 outcomes:
measure: Health Scores
timeFrame: 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).
measure: Depressive Level
timeFrame: 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).
measure: Anxiety Level
timeFrame: 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).
measure: Stress Level
timeFrame: 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 outcomes:
measure: Basic Knowledge Acquisition
timeFrame: 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).
measure: CAPD Performance
timeFrame: 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).
Locations:
city: Hong Kong
country: Hong Kong
facility: Renal Unit, Department of Medicine, QEH
Study officials:
affiliation: Renal Unit, Queen Elizabeth Hospital
name: Carina HO, APN(Renal)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsieh YP, Wang SC, Chang CC, Wen YK, Chiu PF, Yang Y. The negative impact of early peritonitis on continuous ambulatory peritoneal dialysis patients. Perit Dial Int. 2014 Sep-Oct;34(6):627-35. doi: 10.3747/pdi.2013.00024. Epub 2014 Feb 4.
citation: Lam, E T P, Lam, C L K, Lo, Lo, YC Yvonne, Gandek, B. (2008). Psychometrics and population norm of the Chinese (HK) SF-36 Health Survey_Version 2, HK Pract, 30, 189-197
citation: Lee, A., Koo, J., Wan, S.H., Hui, Y. H., Wong, S. H. & Chan, K. H. (2018). Application of 3D Printing Technology in Fabrication of Renal Device for Self-Continuous Ambulatory Peritoneal Dialysis-A Pilot Study. HA Convention 2018.
citation: Li PK, Szeto CC, Piraino B, de Arteaga J, Fan S, Figueiredo AE, Fish DN, Goffin E, Kim YL, Salzer W, Struijk DG, Teitelbaum I, Johnson DW. ISPD Peritonitis Recommendations: 2016 Update on Prevention and Treatment. Perit Dial Int. 2016 Sep 10;36(5):481-508. doi: 10.3747/pdi.2016.00078. Epub 2016 Jun 9. No abstract available.
citation: Moussa, M.T., Lovibond, P.F. & Laube, R. (2001). Psychometric properties of a Chinese version of the short Depression Anxiety Stress Scales (DASS21). Report for New South Wales Transcultural Mental Health Centre, Cumberland Hospital, Sydney; Available at: http://www2.psy.unsw.edu.au/groups/dass/Chinese/tmhc.htm
citation: Szeto CC, Li PK. Peritoneal Dialysis-Associated Peritonitis. Clin J Am Soc Nephrol. 2019 Jul 5;14(7):1100-1105. doi: 10.2215/CJN.14631218. Epub 2019 May 8.