Table 1.
Primary objective | Primary outcome |
The proportion of eligible subjects agreeing to participate in the study—Recruitability |
|
The proportion of randomised subjects who remain in the study—Retainability | Proportion of patients randomised who remain in the study excluding study withdrawals, and reasons for withdrawals. |
The proportion of subjects who adhere to protocol-driven changes in dialysis frequency—Protocol adherence | Proportion of patients who adhere to protocol dialysis frequency. |
The number of adverse and serious adverse events—Safety of the study | Frequency of hospital admission due to hyperkalaemia and fluid overload, and lower respiratory tract infection. |
An estimate of the effectiveness of the intervention—Effect size |
|
Secondary objectives | Secondary outcome |
Retention of RKF | Proportion of patients with interdialytic urea clearance ≥2 and ≥3 mL/min/1.73 m2 at 6 months. |
Quality of life (QOL) | QOL is assessed using EQ-5D-5L questionnaire. |
Mood—depression | Depression assessed using PHQ-9 questionnaire. |
Cognitive function | Change in cognitive function as assessed by MOCA tool. |
Illness intrusiveness | Illness intrusiveness is assessed using Illness Intrusiveness Rating Scale. |
Functional status/frailty | Functional status assessed by Clinical Frailty Score. |
Vascular access failures or problems | Frequency of vascular access failures and interventions. |
Major adverse cardiac events (MACE) | MACE is assessed by recording of the frequency of the events. |
Survival | Survival is measured by all-cause mortality. |
EQ-5D-5L, EuroQol EQ-5D-5L questionnaire; HD, haemodialysis; MOCA, Montreal Cognitive assessment; PHQ-9, Patient Health Questionnaire, 9 question; RKF, residual kidney function; Std Kt/V, Standard Kt/V.