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Table 1 Study schedule of data collection and assessments

From: Evaluation of the effect of Cooled HaEmodialysis on Cognitive function in patients suffering with end-stage KidnEy Disease (E-CHECKED): feasibility randomised control trial protocol

 

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

  1. MoCA Montreal Cognitive Assessment tool, CAM Confusion Assessment Method, QoL quality of life, ADL activities of daily living, HADS Hospital Anxiety and Depression Scale
  2. *Blood pressure (pre and post HD), intradialytic hypotension, nursing interventions for intradialytic hypotension, intradialytic weight gain over preceding 1 month
  3. **KT/V as markers of adequate solute clearance, routine haematology and biochemistry