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Table 1 Flow chart of assessments during the observation period

From: Protocol of a pilot-scale, single-arm, observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients

 

Study observation period (3 weeks)

Baseline clinic Visit

At each dialysis session

Week 1

Week 2

Week 3 (end)

Informed consent

X

    

Demographic data (include dialysis and medicine history)

X

    

Vital signs, body weight, routine hemodialysis measurements in-clinic

X

X

X

X

X

Assess fluid status with bioimpedance

X

 

X

X

X

Instruction/patient training on the use of the Sixty device

X

    

Wear the Sixty device daily

X

X

X

X

X

Download data and recharge the Sixty device

 

X

X

X

X

Record symptoms related to fluid status

X

X

X

X

X

Record adverse events

X

X

X

X

X

Patient records blood pressure at home once/day

Once/day throughout the study

Stop using the Sixty device

    

X

Acceptability of the Sixty device questionnaire

    

X

End of study

    

X