Table 4.

Efficacy of HTN control Intervention Arm (IA) vs. Control Arm (CA)

N	INTERVENTION	CONTROL	p-value
Randomized	34	22
Withdrawn (data not used)	6	0
Intent to Treat for Primary Outcome	28	22
Crossed Over From Intervention to Control	2
As Treated Total for Primary Outcome	26	24
INTENT TO TREAT ANALYSIS
Study Start and End BP reported on N	28	22
SBP < 140 mm Hg at enrollment (goal)	14 (50%)	11(50%)
SBP < 140 mm Hg at study end (goal)	23 (82%)	14(64%)	IA:P=0.0077 CA::p=0.51*
Average SBP Study Start	140.0 (15.7)	139.8 (16.3)
Average SBP Study End	130.2 (11.4)	133.9 (16.9)	IA:p=0.005** CA: p=0.115
AS TREATED ANALYSIS
Study Start and End Blood Pressure data reported on N	26	24
SBP < 140 mm Hg at enrollment (goal)	14 (54%)	11(46%)
SBP < 140 mm Hg at study end (goal)	23 (89%)	14(58%)	IA:P=0.0077 CA::p=0.51*
Average SBP Study Start	139.7 (16.2)	140.2 (15.7)
Average SBP Study End	128.8 (10.5)	135.1 (16.7)	IA: p=0.0036** CA: p=0.1403

^*The McNemar test was similar for the intent to treat and as treated analysis and was significant for the intervention arm (chi-square=7.11, p=0.0077) but not for the control arm, (chisquare=0.44, p=0.51).

^**Intent to treat: Paired T-test Control Arm (CA). Mean difference pre vs. post = 5.91 (95% CI: −1.57,13.38), p=0.115. Intervention Arm (IA). Mean difference pre vs. post = 9.88 (95% CI: 3.17, 16.40), p=0.005. Two-sample t-test comparing mean changes in between groups was not significant, (p=0.4).

^**As treated: Paired T-Test CA. Mean difference pre vs. post = 5.13 (95% CI: −1.82, 12.07), p=0.1403. IA Mean difference pre vs. post = 10.81 (95% CI: 3.86, 17.76), p=0.0036. Two sample t-test comparing mean changes between groups was not significant, (p=0.2).