TABLE 1.
Follow‐up assessment schedule of the trial
Assessments ● Mandatory ○ If needed |
Screening | Treatment period | At withdrawal | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 4 | Week 8 | Week 12 | Medication‐use evaluation | Week 16 | Week 20 | Week 24 | ||||
Day1 | Day 29 | Day 57 | Day 85 | Day 113 | Day 141 | Day 169 | |||||
Scheduled visits | 28 d before registration | Registration | ±14 d | ±14 d | ±14 d | Within 14 d after ABPM at 12 wk | ±14 d | ±14 d | ±14 d | Within 14 d after withdrawal | |
Eligibility | ● | ● | |||||||||
Informed consent | ● | ||||||||||
Registration & Randomization | ● | ||||||||||
Usage monitoring of | |||||||||||
investigational medical device (app) | ● | ● | ● | ○ | ○ | ● | ● | ||||
Baseline characteristics | ● | ||||||||||
Examination | Subjective | ● | ● | ● | ● | ● | ● | ○ | ○ | ● | ● |
Objective | ● | ● | ● | ● | ● | ● | ○ | ○ | ● | ● | |
Physical | Height | ● | |||||||||
Weight | ● | ● | ● | ● | ○ | ○ | ● | ● | |||
BMI | ● | ● | ● | ● | ○ | ○ | ● | ● | |||
Waist circumference | ● | ● | ● | ● | |||||||
Physiological functions | ABPM | ● | ● | ● | ● | ||||||
Home BP and HR (awake and bedtime) | ● | ● | ● | ● | ○ | ○ | ● | ● | |||
Office BP and HR | ● | ● | ● | ● | ○ | ○ | ● | ● | |||
12‐lead ECG | ● | ||||||||||
Epworth sleepiness scale | ● | ||||||||||
Laboratory | Blood test | ● | ● | ● | ● | ||||||
Pregnancy test | ○ | ||||||||||
Urinalysis | ● | ● | ● | ● | |||||||
Salt intake check sheet | ● | ● | ● | ● | |||||||
Medication usage | ● | ○ | ○ | ● | ○ | ||||||
Concomitant medication & treatment | ● | ● | ● | ||||||||
Adverse events | ● | ● |