TABLE 2.

Primary and secondary outcomes

Primary outcome

Mean change in 24‐h SBP by ABPM at 12 wk

Secondary outcomes

[Evaluated at both 12 and 24 wk]

1) Management rate (goal 1, home SBP < 135 mmHg and DBP < 85 mmHg; goal 2, home SBP < 125 mmHg and DBP < 75 mmHg)

2) Efficacy rate (percentage of patients whose mean change in 24‐h SBP is equal to or more than 5 mmHg)

3) Mean changes by ABPM in 24‐h DBP

4) Daytime/nighttime SBPs and DBPs, 24‐h pulse pressure, 24‐h/daytime/nighttime HRs, and 24‐h SBPs and DBPs in the extreme‐dipper/dipper/non‐dipper/riser groups

5) Coefficient of variations in 24‐h/daytime/nighttime SBPs and DBPs

6) Mean changes in home awake and nighttime SBP, DBP, and HR

7) Coefficient of variations in home awake and bedtime SBP and DBP

8) Mean changes in office SBP, DBP, and HR

9) Mean changes in weight, BMI, and waist circumference

10) Mean change in points obtained by salt intake check sheet

11) Changes in each variable by blood tests and urinalysis

12) Smartphone app‐related variables (app usage rate, progress of app educational programs, etc.)

13) Rate of home BP measurement, rate of behavior modification, and rate of self‐monitoring

14) Any adverse events including device‐related adverse events

15) Malfunctions of the investigational medical device

[Evaluated at 24 wk]

16) Mean change in 24‐h SBP by ABPM at 24 wk

17) Percentage of medication users; mean changes between 12 and 24 wk by ABPM in 24‐h/daytime/nighttime SBPs and DBPs

18) Mean changes between 12 and 24 wk in home awake/bedtime SBPs and DBPs

Abbreviations: ABPM, ambulatory blood pressure monitoring; BMI, body mass index; DBP, diastolic blood pressure;HP, heart rate; SBP, systolic blood pressure.