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

NCT05521425 | Unknown

• 1 other identifier: 20-0266-FR-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Failure Chronic

Keywords

Continuous Ambulatory Peritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Health Scores

  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

  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

  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

  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 (2)

• Basic Knowledge Acquisition

  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

  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).

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Device: "Helping Hands" for CAPD bag exchange procedures

Control Group

NO INTERVENTION

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

Interventions

"Helping Hands" for CAPD bag exchange procedures 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Elizabeth Hospital, Hong Kong: lead

Study Sites (1)

Renal Unit, Department of Medicine, QEH

Hong Kong, 852, Hong Kong

RECRUITING

Related Publications (6)

• 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.

  PMID: 24497590 BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 27282851 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 31068338 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carina HO, APN(Renal)

  Renal Unit, Queen Elizabeth Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carina HO, APN(Renal)

CONTACT

852-3506; hkm320@ha.org.hk

Victor CHEUNG, EOII(MDSSC)

CONTACT

852-3506; ckl414@ha.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Non-inferiority, Paralleled, Randomized Controlled Trial

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 30, 2022
• Study Start: December 1, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)