Renal Failure Chronic Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Renal Unit, Department of Medicine, QEH | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Queen Elizabeth Hospital, Hong Kong |
Hong Kong,
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. — View 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
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.
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. Review. Erratum in: Perit Dial Int. 2018 Jul-Aug;38(4):313. — View 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
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Basic Knowledge Acquisition | 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). | |
Other | CAPD Performance | 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). | |
Primary | 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 | 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). | |
Secondary | 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). | |
Secondary | 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). | |
Secondary | 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). |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03246984 -
VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ
|
N/A | |
Completed |
NCT05787080 -
Massage, Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome(RLS)
|
N/A | |
Completed |
NCT05585268 -
Electronic Decision Support for Deprescribing in Patients on Hemodialysis
|
N/A | |
Completed |
NCT02332811 -
An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic CKD Patients
|
Phase 3 | |
Withdrawn |
NCT03093740 -
Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant
|
Phase 4 | |
Recruiting |
NCT04908345 -
Methadone Anesthesia For Kidney Transplant Receptors
|
Phase 3 | |
Completed |
NCT05769686 -
Laparoscopic Donor Nephrectomy Score, a New Scoring System for Preoperative Prediction of Difficulty of Laparoscopic Donor Nephrectomy
|
||
Completed |
NCT03949036 -
Comparison of Two Different Preload Targets of Stroke Volume Variation During Kidney Transplantation
|
N/A | |
Completed |
NCT04204005 -
Probiotics and Low Protein Diet in Advanced Chronic Kidney Disease
|
N/A | |
Completed |
NCT03658876 -
Predictors of Response to Iron and Erythropoietin Stimulating Agents
|
Phase 4 | |
Not yet recruiting |
NCT04377243 -
Immunotherapy of Chronic Kidney Failure
|
Phase 2 | |
Active, not recruiting |
NCT05418816 -
SelfWrap-Assisted Arteriovenous Fistulas
|
N/A | |
Completed |
NCT06454981 -
Clinical Trial for Effectiveness and Safety Evaluation of Hemodiafilter
|
N/A | |
Active, not recruiting |
NCT03436368 -
Continuous Spinal Anesthesia in Renal Transplantation
|
N/A | |
Recruiting |
NCT03778944 -
Enhancing Renal Graft Function During Donor Anesthesia
|
N/A | |
Recruiting |
NCT05077163 -
Patients With Acute Renal Failure During Severe COVID-19
|
||
Active, not recruiting |
NCT05381961 -
Observational Study of BIS in Hemodialysis Patients
|
||
Completed |
NCT03781726 -
Multi-center Study to Transplant Hepatitis-C Infected Kidneys
|
Phase 4 |