Renal Failure Chronic
Conditions
Keywords
Continuous Ambulatory Peritoneal Dialysis
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). \[May refer to sessions of Outcome measures and Eligibility for details\]
Interventions
DEVICEHelping 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.
Sponsors
Queen Elizabeth Hospital, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Non-inferiority, Paralleled, Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peritonitis Rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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). |
| 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). | 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). |
| 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). | 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). |
| 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). | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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%). |
| 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). | 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. |
Countries
Hong Kong
Contacts
Primary ContactCarina HO, APN(Renal)
Backup ContactVictor CHEUNG, EOII(MDSSC)
Outcome results
None listed