Efficacy of a brief multifactorial adherence-based intervention in reducing blood pressure: a randomized clinical trial

Figures & data

Figure 1 Trial profile.

Table 1 Baseline demographic and clinical characteristics in the control and intervention groups

Baseline characteristics	Control group n/N (%)	Intervention group n/N (%)	P-value
Age*	66.7±11.7	64.5±9.8	0.145
Men	55/102 (53.9)	62/105 (59.0)	0.485
Marital status
Married/cohabiting	61/101 (60.4)	67/105 (63.8)
Single/divorced/widowed	40/101 (39.6)	38/105 (36.2)	0.667
Level of education
None	23/107 (21.5)	21/114 (18.4)
Elementary school	58/107 (54.2)	62/114 (54.4)
Middle or high school	17/107 (15.9)	18/114 (15.8)
University studies	9/107 (8.4)	13/114 (11.4)	0.859
Social class
Class I–II	3/76 (3.9)	3/81 (3.7)
Class III	53/76 (69.7)	64/81 (79.0)
Class IV–V	20/76 (26.3)	14/81 (17.3)	0.380
SBP, mmHg*	155.5±13.4	156.3±15.1	0.697
DBP, mmHg*	83.6±10.3	84.7±10.7	0.436
Baseline heart rate, bpm*	75.1±13.5	76.0±14.5	0.645
Severe hypertension	4/104 (3.8)	7/105 (6.7)	0.361
Hypertension duration (years)*	7.0±5.9	6.3±6.2	0.517
No of AHT drugs at baseline*	2.3±1.1	2.3±1.2	0.754
Baseline adherence to AHT treatment*	76.49±30.9	75.14±26.2	0.789
Cardiovascular risk factors
Cigarette smoking	16/104 (15.4)	21/105 (20)	0.532
Hypercholesterolemia	57/104 (54.8)	61/105 (58.1)	0.632
Diabetes mellitus	48/104 (46.2)	53/105 (50.5)	0.532
Obesity (BMI >30 kg/m^2)	52/104 (50)	62/105 (59)	0.189
Family history of premature CHD	5/104 (4.8)	8/105 (7.6)	0.400
Target organ damage
Left ventricular hypertrophy	0/104 (0)	3/105 (2.4)	0.08
Microalbuminuria	4/104 (3.8)	2/105 (1.9)	0.401
Elevated serum creatinine	5/104 (4.8)	4/105 (3.8)	0.722
Nephropathy	9/105 (8.6)	5/104 (4.8)	0.260
Cardiovascular diseases
Stroke	3/104 (2.9)	2/105 (1.9)	0.643
Ischemic heart disease	5/104 (4.8)	9/105 (8.6)	0.276
Congestive heart failure	5/104 (4.8)	6/105 (5.7)	0.769
REGICOR cardiovascular risk	1.46 (0.6)	1.52 (0.74)	0.582

Note:

* Data are expressed as mean ± standard deviation.

Abbreviations: n, sample; N, population; BMI, body mass index; CHD, cardiovascular disease; SBP, systolic blood pressure; DBP, diastolic blood pressure; AHT, antihypertensive; REGICOR, Registre Gironí del cor.

Table 2 Blood pressure measures in the control and intervention groups at 12 months

Efficacy	12 months
	Unadjusted analysis			Adjusted analysis#
	Control	Intervention	P-value	Control	Intervention	P-value
SBP, mmHg, mean (SD)	153.7 (16.8)	151.3 (17.8)	0.294	153.8 (0.70)	151.3 (0.54)	0.290
DBP, mmHg, mean (SD)	83.6 (11.4)	83.4 (11.1)	0.917	83.6 (0.71)	83.5 (0.62)	0.901
ΔSBP, mmHg, mean (SD)*	−2.1 (16.8)	−5 (18.3)	0.208	−2.1 (1.58)	−5.1 (1.71)	0.219
ΔDBP, mmHg, mean (SD)*	−0.1 (9.1)	−1.2 (9.1)	0.405	−0.16 (0.43)	−1.19 (0.47)	0.515

Note:

# Adjusted for changes in AHT medication over time.

* Δ represent changes in SBP and DBP between the baseline value and the 12 months value.

Abbreviations: SBP, systolic blood pressure; DBP, diastolic blood pressure; SD, standard deviation; AHT, antihypertensive.