Parameter | Study period: time (month) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Screening | Assessment and follow-up | Close-out | ||||||||||
-1 | 0 | 3 | 6 | 9 | 12 | 15 | 18 | 21 | 24 | 25 | 26 | |
Check eligibility against inclusion/exclusion criteria and medication review | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Screening for S. aureus colonization | X | Â | Â | X | Â | X | Â | X | Â | X | Â | Â |
Gartering informed consent and randomization | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Sociodemographic and lifestyle dataa | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Medical history by Charlson comorbidity index and ESKD etiology | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Physical examination | X | X | X | X | X | X | X | X | X | X | Â | Â |
PD-related infection: dialysate characteristics and exit-site assessment | Â | X | X | X | X | X | X | X | X | X | Â | Â |
Routine laboratory tests (performed locally)b | Â | X | X | X | X | X | X | X | X | X | Â | Â |
Dialysate adequacy and peritoneal equilibration test | Â | X | Â | Â | Â | X | Â | Â | Â | X | Â | Â |
HRQOL and mental healthc | Â | X | Â | X | Â | X | Â | X | Â | X | Â | Â |
Record medication changes | Â | X | X | X | X | X | X | X | X | X | Â | Â |
Safety profiles: skin reactions and adverse events documentation | Â | X | X | X | X | X | X | X | X | X | X | Â |
Hospitalization and emergency visit | Â | X | X | X | X | X | X | X | X | X | Â | Â |
Assess adherence with trial treatment allocation and other medicationd | Â | Â | X | X | X | X | X | X | X | X | Â | Â |
Healthcare costs: direct medical cost, direct non-medical cost, and indirect cost | Â | X | Â | Â | Â | X | Â | Â | Â | X | Â | Â |
Data monitoring | Â | Â | X | X | X | X | X | X | X | X | Â | Â |
Statistical analysis and reporting | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | X | X |