Table 6.
Time schedule of assessment for patients and caregivers enrolled in the TwoPlus trial
| Category | Assessment | Study month | ||||
|---|---|---|---|---|---|---|
| M0 | M6 | M12 | M18 | M24 | ||
| M30 | M36 | M42 | M48 | |||
| Prescreening and Screening: Patient and Caregiver | ||||||
| Patient | Prescreening: Clinical inclusion and exclusion criteria | x | ||||
| Informed consent | x | |||||
| Urine screen questionnaire | x | |||||
| Trail Making Test B | x | |||||
| Screening: Baseline residual kidney function | x | |||||
| Caregiver | Informed consent, Socio-demographics, Employment status, Zarit scale | |||||
| Pre-Randomization: Patient | ||||||
| Questionnaires | Illness Intrusiveness Rating Scale | x | ||||
| Time to recover from a dialysis session | x | |||||
| EuroQoL-5 Dimensions-5 Level | x | |||||
| SONG-HD Fatigue | x | |||||
| Clinical | Socio-demographics | x | ||||
| KDRD Etiology and Comorbid conditions | x | |||||
| In-center and home medications and dose | x | |||||
| Laboratory | eGFR pre-KDRD (most recent prior to HD initiation) | x | ||||
| Labs pre-ESKD: chem, hematology (most recent prior to HD initiation) | x | |||||
| Dialysis | Initial HD, as prescribed by treating team (when applicable) | x | ||||
| Vascular access for HD † | x | |||||
| Labs pre-HD: chem, hematology (most recent, after HD was started) | x | |||||
| Target weight, Pre-HD weight, Post-HD weight, UF rate (mL/kg/h) | x | |||||
| Pre- and Post-HD BP and HR, nadir BP and HR, peak BP and HR | x | |||||
| spKt/V, nPCR | x | |||||
| Post-Randomization: Patient Follow-up | ||||||
| Clinical | ED visits without hospitalization | Monthly | ||||
| Hospitalizations | Monthly | |||||
| Death | Monthly | |||||
| In-center and home medications and dose | Monthly | |||||
| Laboratory & Dialysis | Timed urine collection, Residual kidney function assessment | Every 3 months | ||||
| HD treatments: prescribed and delivered | All treatments | |||||
| Vascular access: used for HD, complications | Dec, Mar, Jun, Sept | |||||
| Attendance of HD treatments; Shortened HD treatments by ≥15 min | Dec, Mar, Jun, Sept | |||||
| Labs pre-HD: chem, hematologyb | Monthly | |||||
| Target weight, Pre-HD weight, Post-HD weight, UF rate (mL/Kg/h) | Dec, Mar, Jun, Sept | |||||
| Pre- and Post-HD BP and HR, nadir BP and HR, peak BP and HR | Dec, Mar, Jun, Sept | |||||
| spKt/V, dialysis stdKt/V, renal stdKt/V, total stdKt/V, nPCR | Dec, Mar, Jun, Sept | |||||
| Questionnaires | Urine screen questionnaire | Monthly | ||||
| Illness Intrusiveness Rating Scale | Monthly | |||||
| Time to recover from HD | Monthly | |||||
| EuroQoL-5 Dimensions-5 Levelc | x | x | x | x | ||
| Employment statusc | x | x | x | x | ||
| SONG-HD Fatiguec | x | x | x | x | ||
| Cognitive function | Trail Making Test Part B | x | x | x | x | |
| Caregiver Follow-up | ||||||
| Questionnaires | Employment Status, Zarit scale | x | x | x | x | |
Timepoint of assessment (months) is set from the month of baseline residual kidney function for patients, and month of informed consent for caregivers. BP Blood pressure, GFR Glomerular filtration rate, HD hemodialysis, HR Heart rate, KDRD Kidney dysfunction requiring dialysis, UF Ultrafiltration, spKt/V Single pool (or per HD treatment) urea Kt/V, stdKt/V Standard (or per week) urea Kt/V, UF Ultrafiltration
Information accompanying superscript characters is found in the Additional file 2