Table 1.
Study schedule of data collection and assessments
| Baseline (O month) | 6 months | 12 months | |
|---|---|---|---|
| Consent | X | ||
| Randomisation | X | ||
| Baseline data (defined) | X | ||
| Cognitive function: | |||
| Montreal Cognitive Assessment [31] | X | X | X |
| Cogstate [32] | X | X | X |
| Confusion Assessment Method [33] | X | X | X |
| Tolerability of Low Temperature Dialysis Questionnaire | Every 2 weeks for the first 6 weeks | ||
| Activities of daily living: | |||
| Assessment of QoL [34] | X | X | X |
| Bristol Activities of Daily Living Scale [35] | X | X | X |
| Carer burden assessment [36] | X | X | X |
| Hospital Anxiety and Depression Scale [37] | X | X | X |
| HD recovery time [38] | X | X | X |
| Qualitative interview | At completion or drop out | ||
| Dialysis temperature recording | During each HD session | ||
| Physiological measurements* | During each HD session | ||
| Laboratory measurements** | Measured monthly as part of routine care | ||
| Adverse event reporting | X | X | X |
| Review Concomitant Medications | X | X | X |
MoCA Montreal Cognitive Assessment tool, CAM Confusion Assessment Method, QoL quality of life, ADL activities of daily living, HADS Hospital Anxiety and Depression Scale
*Blood pressure (pre and post HD), intradialytic hypotension, nursing interventions for intradialytic hypotension, intradialytic weight gain over preceding 1 month
**KT/V as markers of adequate solute clearance, routine haematology and biochemistry