Table 2.
Schedule of enrolment, intervention and assessments
| Study period | ||||||
| Time point | Recruitment | Trial visits | ||||
| W24† | Active | Washout | ||||
| W0 | W2 | W4 | W8 | W12 | ||
| Enrolment | ||||||
| Screening | X | |||||
| Informed consent | X | |||||
| Randomisation | X | |||||
| Intervention | ||||||
| High water intake | ||||||
| Ad libitum water intake | ||||||
| Assessment | ||||||
| Medical history | X | |||||
| Medication review | X | X | X | X | X | X |
| Physical examination | X | X | X | X | X | X |
| Vital signs (blood pressure, pulse rate and oximetry) | X | X | X | X | X | X |
| Height | X | |||||
| Weight | X | X | X | X | X | X |
| Haematology (full blood count) | X | |||||
| Biochemistry (urea, creatinine, electrolytes, serum osmolality) | X | X | X | X | X | X |
| Biochemistry (liver function and bone profile) | X | |||||
| Measured GFR* | X | X | X | |||
| Urine SG | X | X | X | X | X | X |
| Spot urine osmolality | X | X | X | X | X | X |
| 24 hours urine collection (volume and osmolality) | X | X | X | X | ||
| Home uSG monitoring‡ | X | X | X | X | ||
| SPLASH monitoring | X | X | X | X | ||
| Dietary assessment | X | X | X | X | ||
| Pain questionnaire‡ | X | X | ||||
| Acceptability questionnaire‡ | X | X | ||||
| EQ5D‡ | X | X | ||||
*51Cr-EDTA measured GFR performed as part of a substudy in eight participants in the HW group.
†24 weeks prestudy recruitment period.
‡Recorded using the DRINK smartphone app.
GFR, glomerular filtration rate; uSG, urine specific gravity.