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 | ● | ● | |||||||||