| VISITS (Months) All undertaken at routine dialysis sessions | Urine Collections | Trial completion | Event based | |||||
---|---|---|---|---|---|---|---|---|---|
Procedure | Visit −1 | BaselineVisit 0 | Visit 1 | Visit 2 | Visit 3 | Visits 4–11 At 6,9,12,15,18,21,24 Months. | At 5,7,9,11,13,15,17,19,21,23,24 months. includes extra 2 weeks after primary endpoint is reached |  |  |
Eligibility | x | Â | Â | Â | Â | Â | Â | Â | Â |
Consent | x | Â | Â | Â | Â | Â | Â | Â | Â |
Residual kidney function tests for normalized GFR (urine volume and urine + blood to lab) | x |  | x | x | x |  | x |  |  |
Height (cm) | x | Â | Â | Â | Â | Â | Â | Â | Â |
Web-based randomisation | Â | x | Â | Â | Â | Â | Â | Â | Â |
Date of birth | Â | x | Â | Â | Â | Â | Â | Â | Â |
Ethnicity | Â | x | Â | Â | Â | Â | Â | Â | Â |
Sex | Â | x | Â | Â | Â | Â | Â | Â | Â |
Full medication list | Â | x | Â | Â | Â | Â | Â | Â | Â |
Primary Renal Disease Diagnosis | Â | x | Â | Â | Â | Â | Â | Â | Â |
Stoke comorbidity score | Â | x | Â | Â | Â | Â | Â | Â | Â |
Renal Registry comorbidity fields | Â | x | Â | Â | Â | Â | Â | Â | Â |
Planned/unplanned start | Â | x | Â | Â | Â | Â | Â | Â | Â |
Access type (fistula/graft/line) | Â | x | Â | Â | Â | Â | Â | Â | Â |
HD modality: (HD, HDF) | Â | x | Â | Â | Â | Â | Â | Â | Â |
Incremental/full start dialysis | Â | x | Â | Â | Â | Â | Â | Â | Â |
Transplant wait listed | Â | x | Â | Â | Â | Â | Â | Â | Â |
Dialysis prescription | Â | x | Â | Â | Â | Â | Â | Â | Â |
Bioimpedence with full dataset using software | Â | x | x | x | x | x | Â | Â | x if indicated |
BISTRO Study intervention record | Â | x | x | x | x | x | Â | Â | x if indicated |
Duke Activity Status Index (ASI) | Â | x | Â | Â | x | x | Â | Â | Â |
Patient Activation Measure (PAM) | Â | x | Â | Â | x | x | Â | Â | Â |
EQ-5D-5Â L | Â | x | Â | Â | x | x | Â | Â | Â |
IPOS-Renal patient version | Â | x | Â | Â | x | x | Â | Â | Â |
Haemodialysis symptoms questionnaire | Â | x | Â | Â | x | x | Â | Â | Â |
Short Form (SF-12) Health Survey | Â | x | Â | Â | x | x | Â | Â | Â |
CSRI CKD | Â | x | Â | Â | x | x | Â | Â | Â |
Cognitive Assessment (MoCA) | Â | x | Â | Â | Â | Â | x annually | Â | Â |
Study Termination/completion form | Â | Â | Â | Â | Â | Â | Â | x | x |
Adverse events | Â | Â | Â | Â | Â | Â | Â | Â | x |