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Table 3 The schedule of enrolment, randomisation, assessments and follow-up

From: The NightLife study — the clinical and cost-effectiveness of thrice-weekly, extended, in-centre nocturnal haemodialysis versus daytime haemodialysis using a mixed methods approach: study protocol for a randomised controlled trial

Procedure

Screening

Baseline

1 month

2 months

3 months

4 months

5 months

6 months

3 years

Review eligibility criteria

X

X

       

Written informed consent

 

X

       

Demographic data and medical history

 

X

       

Questionnaires: KDQoL, EQ-5D-5L, PSQI, SONG-HD, TTR

 

X

X

 

X

  

X

 

MoCA

 

X

  

X

  

X

 

Baseline health economics questionnaire

 

X

       

Randomisation

 

X

       

Intradialytic urine collection and paired blood samples*

 

X

     

X

 

Serum beta-2 microglobulin*

 

X

X

X

X

X

X

X

 

Resource use and expenditure questionnaire

  

X

 

X

  

X

 

Routine clinical data including adherence, dialysis adequacy, blood pressure and monthly blood results

 

X

X

X

X

X

X

X

 

Capture of routine clinical data and resource usage (UKRR, SRR, HES, ONS, ISD)

        

X

  1. *Blood samples drawn at the same time as routine clinical testing. Routinely collected data on all dialysis units