Table 2 Secondary outcome measures for Workstream 1 (main randomised controlled trial)
Secondary outcome measures | Follow-up |
|---|---|
Patient reported outcome measures | |
KDQoL total score | 1, 3 and 6 months |
KDQoL domains: Physical Component Summary Score (PCS), Mental Component Summary Score (MCS), Kidney Summary Score (KSS), Kidney Disease Component Summary Score (KDCS) | 6 months |
EuroQol EQ-5D-5L: will be used to determine health state descriptions for the five components (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) combined with health-related quality of life index scores to generate quality-adjusted life year (QALY) profiles for the cost-effectiveness analysis | 1, 3 and 6 months |
The SONG-HD fatigue score to evaluate fatigue experience by individuals on long-term dialysis | 1, 3 and 6 months |
Pittsburgh Sleep Quality Index (PSQI); a validated tool to assess sleep quality in people on dialysis and the association between sleep and lower health-related quality of life | 1, 3 and 6 months |
Time to recover in minutes after dialysis; a simple, reliable and sensitive validated tool | 1, 3 and 6 months |
Cognitive function | |
The Montreal Cognitive Assessment (MoCA) will be used to explore changes in cognitive function. The MoCA is a well-known validated tool for assessing cognitive health and can be used for individuals on long-term dialysis | 3 and 6 months |
Measures of safety | |
44-h intradialytic urine collection with paired blood samples to estimate residual kidney function | 6 months |
Serum beta-2 microglobulin, a validated surrogate for residual kidney function in individuals on long-term haemodialysis | Monthly |
Serious adverse events (SAEs): | Monthly |
• SAEs in totality (rate/years) | |
• Vascular access complications that lead to SAEs (rate/years) | |
• Dialysis prescription changes that lead to SAEs (rate/years) | |
Clinical events: | Monthly |
• Cardiovascular events (rate/years) | |
• Cardiovascular mortality (rate/years) | |
• Overall mortality (rate/years) | |
Impact on clinical parameters | |
Blood results: haemoglobin, ferritin, transferrin saturation, calcium, potassium, phosphate, parathyroid hormone | Monthly |
Dialysis adequacy assessed via urea reduction ratio and Kt/V (determined from pre-dialysis urea, post-dialysis urea, post-dialysis weight and ultrafiltration volume | Monthly |
Pre-dialysis blood pressure | Monthly |
Medication prescription: antihypertensive agents, phosphate binders, potassium binders, erythropoietin, iron supplementation | 6 months |
Adherence to allocated study arm | |
Number of missed dialysis sessions | Monthly |
Minutes per dialysis session | Monthly |
Number of dialysis sessions not achieving time criteria | Monthly |
Number of temporary changes from treatment allocation (i.e. participant allocated to intervention dialysing during the day | Monthly |
Cost-effectiveness | |
Resource use and expenditure questionnaire | 1, 3 and 6 months |