AJH

2006; 19:737743

Therapeutics

Effect of Education on Blood

Pressure Control in Elderly Persons
A Randomized Controlled Trial

E
Background: It is not clear which educational strategy
is most effective in helping patients to change their lifestyles. This study compared the efficacy of two different
educational models on reducing blood pressure (BP).
Methods: This was a randomized controlled trial in
ambulatory hypertensive patients 65 years of age. Workshops that aimed to develop self-management and patient
empowerment (PEM) were compared to workshops that
used a compliance-based model (CEM). The primary outcome was change in systolic BP at 3 months compared
with basal values between groups (net reduction), measured by 24-h ambulatory BP monitoring.
Results: A total of 30 patients were educated with PEM
and 30 others with CM. Both groups were statistically
similar with regard to age (67 v 70 years), systolic BP (157
v 156 mm Hg) and diastolic BP (88 v 88 mm Hg), diabetes
(23% v 31%), and basal natriuresis 116 v 121 mEq/day).

There were more women in the PEM group (57% v 30%).

The PEM group showed a significant reduction of 8 mm
Hg (95% confidence interval [CI] 2 to 15), whereas the
CM group showed a reduction of 3 mm Hg (95% CI 3
to 8), with a net reduction of 6 (95% CI 3 to 14). Mean
net night-time systolic BP reduction was 12 mm Hg (95%
CI 2 to 22). BP control was 70% in PEM group vs 45% in
CM group (P 0.045). The relative odds ratio for BP
control for the PEM group after adjustment for age, sex,
diabetes, basal blood pressure and changes in pharmacological treatment was 3.7 (95% CI 1.05 to 13.1).
Conclusion: Based on these study results, the selfmanagement education model was significantly more
effective than the compliance-based model in BP control. Am J Hypertens 2006;19:737743 2006 American Journal of Hypertension, Ltd.
Key Words: Hypertension, self-efficacy, elderly.

ifestyle change is commonly assumed to be difficult to

achieve, and self-management education interventions
often have limited success in reducing behavioral risk
factors.1,2 Self-management education programs are heterogeneous and there is evidence that their benefit in reducing
blood pressure (BP) is relatively small.3 Such programs are
not usually used in elderly individuals because of the assumption that these individuals are unwilling to engage in healthpromoting behaviors, although this presumption is not
justified.4
The most challenging issues in education involve helping
patients to make long-term lifestyle changes. The basis of the
patient empowerment approach is to help patients to become
responsible for setting their own health care goals and to
implement the behavioral changes required to reach these
goals.5

According to current evidence, the way in which education is implemented could be important in helping patients to make long-term, difficult lifestyle changes based
on partial evidence. Our health plan emphasizes the importance of empowering patients at high risk to make
educated decisions regarding health and lifestyle, using a
patient-empowerment model (PEM). The PEM approach
aims at behavioral and beliefs changes that can sustain
changes over the course of time. More widely used, however, is a compliance-based model (CM) that is based on
medical authority, with a paternal attitude from health care
team members. Physicians have traditionally give advice
on what to do to avoid dreaded health complications in the
future.5,6 However, it has not been clear whether the PEM
approach is superior to traditional educational models, as
both require further study.

Received May 9, 2005. First decision October 14, 2005. Accepted

October 18, 2005.
From the Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.

Address correspondence and reprint requests to Dr. Silvana Figar,

Mons. Larumbe 3151, app. 734, Martinez, Buenos Aires (1640), Argentina; e-mail: silvana.figar@hospitalitaliano.org.ar

2006 by the American Journal of Hypertension, Ltd.

Published by Elsevier Inc.

0895-7061/06/$32.00
doi:10.1016/j.amjhyper.2005.10.005

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AJHJuly 2006 VOL. 19, NO. 7

EDUCATION AND BLOOD PRESSURE CONTROL IN ELDERLY PERSONS

Table 1. Differences between patient education models studied

Compliance-based model
Based on patients complying with what a
health team member explains that is
good for them
Communicational issues:
Message is disease-centered
Do and Don
t are usually part of the
messages conveyed
Motivation is based on vulnerability of the
patient and fear of complications
Paternal attitude from health team member;
presentations usually based on graphs
and figures
Content is organized according to risk factors
Examples of topics addressed
What is hypertension?
Why is the patient hypertensive?
Impact on target organs
Chronic asymptomatic nature of disease
Advice on self-monitoring (frequency)
Hyposodic diet (lists of high-sodium foods)
Advice on high vegetable intake
Advice on weight loss

In addition, a gap has been found between office BP

measurements and 24-h ambulatory BP monitoring
(ABPM)7 This gap probably represents a white coat effect
and suggests that, when defining hypertension treatment
success, methods that do not involve the measurement of
BP by a physician should be considered.7
The aim of the study was to compare the efficacy of the
self-management empowerment education model (PEM)
with that of the compliance-based approach education
model (CM) on reducing BP measured by 24-ABPM
among elderly hypertensive patients. Theoretical and practical differences in the two models are summarized in
Table 1.

Patient empowerment model

Based on development and enhancement
of previously existing resources,
capacities, and knowledge; final aim is
behavioral change
Communicational issues:
Message is patient-centered
Enhancement of perception of patient
s
abilities
Develop ways and mechanisms to
achieve agreed-upon goals.
Motivation is centered on patient
s needs,
stressing quality of life
Method requires patient commitment and
participation; health team member is a
helper
Treatment aims at risk factors that are
common to prevalent conditions
Examples of topics addressed:
Patient
s beliefs on source of
hypertension
Natural variability of the disease
Tips for cooking healthy food; cooking
recipes, provided by patients themselves
How to read and interpret food labels
Barriers to compliance with treatment and
ways to overcome them

including those using diuretics, to avoid influence on natriuresis. The study subjects were selected among patients
seen in the disease management program office who
agreed to participate in the study. The disease management
program at our hospital is a comprehensive, primary care
based program launched to reach all members with
chronic disease.14
From these patients, the first two seen in the clinic
every day were included; thus 10 patients per week were
enrolled. The recruitment period lasted 6 weeks to reach
the sample size (Fig. 1). After 3 months a research assistant who had not previously been involved with the subjects and was therefore blinded to treatment allocation
reassessed both groups.

Methods
84 potentially elegible

This study was a pragmatic, blinded, and randomized

controlled trial with concealed allocation.
Study Population
Eligible patients were hypertensive affiliates of Health
Maintenance Organization of the Hospital Italiano. All
patients were 65 years of age and were without dementia
(based on a Mini-Mental test score 27), illiteracy, or
severe physical disability. All patients with therapeutic
changes in the 3 weeks before the study were excluded,

60 Randomization
30 PEM

29 attended educational sessions

25 with final 24 AMBP

24 Not elegibles
30 CM

28 attended educational sessions

25 with final 24 AMBP

FIG. 1 Flow chart of study subjects in trial comparing the effects on

blood pressure control achieved through a patient empowerment
model of education (PEM) versus a compliance-based model (CM) in
elderly hypertensive patients. ABPM ambulatory blood pressure
monitoring.

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EDUCATION AND BLOOD PRESSURE CONTROL IN ELDERLY PERSONS

739

Intervention

Sample Size

We designed an educational intervention that directly

targeted aspects of patients hypertension management,
commonly referred to as a self-management intervention or patient empowerment approach.8 Our intervention included multiple theories and was tailored to our
population according to Social and Educational Diagnosis of predisposing, reinforcing, and enabling constructs in educational diagnosis and evaluation
(PRECEDE) model.8,9
The learning experiences had different instructional
strategies that focused on the following: gaining attention
(relative advantage of innovation and health benefits);
introducing friendly material through empathy; taking into
account audience knowledge, values, needs, and self-efficacy; and introducing changes in lifestyle in an easy and
practical way. This can be achieved by training in skills
such as group facilitation, problem solving, goal setting,
and cognitive behavioral techniques, which are not usually part of training for most health care professionals.10 12
The control workshop was based on the compliancebased model.13 This model assumes that patients should
obey (ie, that they have an obligation to follow) the treatment recommendations of health care professionals; thus
this workshop gives information focusing on what patients
should and should not do. The contents of both workshops
were based on hypertension management guidelines from
National Institutes of Health and the American Heart Association.14,15 Both workshops had four consecutive sessions of 2 h each and were given weekly to a group of 10
patients.
Three intervention (PEM) and three control (CM)
workshops were simultaneously given. The trainers were
physicians with significant experience in hypertension education and management.16

The sample size calculation was based on detecting a

systolic BP difference between groups of 5 mm Hg according to our previous experience.17 We estimated that
control group would have a 2mm Hg reduction in the
final ABPM.18 We calculated that 32 patients would be
required in each group to show significant difference at the
5% level of probability and 80% power. To allow for
dropouts we sought to recruit 84 patients.

Randomization and Blinding

A research assistant at a distant site used computer block
(six patients) randomization with random number tables,
to allocate patients to intervention or control group. Once
a patient arrived at the workshop the research assistant was
phoned by the monitor, just before the workshop began,
and the patient was directed to the allocated room. Two
different physician educators concurrently offered the
workshops.
Primary care physicians were blinded to patient allocation group. Referral to hypertension specialists was allowed to physicians other than the training educators.
The research monitor, who was also blinded to the
patients allocation groups and had no previous involvement with the trial, carried out the final clinical assessment.

Basal and Final Clinical Assessment

This included BP measurement (three measurements taken
5 min apart with a digital BP device (OMROM-450 as
described elsewhere (OMRON Healthcare Inc., Vernon
Hills, IL)).17
Twenty-Four-Hour Urine Collection for
Sodium and Potassium Urinary Excretion
All blood analyses were carried out in the same laboratory.
Noninvasive ABPM was measured with a SpaceLabs automatic device (model 900202; SpaceLabs, Redmond, WA).
Study Outcomes
The main study outcome was systolic BP measured by
24-h ambulatory monitoring, measured as the mean difference, and the BP control on final ABPM (defined as the
proportion of patients with mean 24-h BP 140/90 mm
Hg). Diastolic BP measured by ABPM, office systolic and
diastolic BP readings, and natriuresis were also assessed as
secondary outcomes.
Statistical Analysis
Normal continuous variables are expressed as mean
(SD) and compared with the t test for independent
samples. Non-normal continuous variables are expressed
as median (25th to 75th centiles) and are compared using
the Mann-Whitney statistic. The basal dichotomous variables were compared using 2 analysis. Paired t tests were
used to compare BP differences within the PEM and CM
groups. Final systolic BP between groups was compared
with independent t test. Basal and final 24-h natriuresis
and kaliuresis excretion were analyzed with Wilcoxon
sign-rank test. Logistic regression was used to compare the
adjusted BP control rate between groups, age, sex, history
of diabetes, initial BP, and changes in pharmacologic
treatment were the variables that best fit the model.
We expressed the net reduction as the difference in
outcome reduction between groups at a 95% confidence
level. The intention to treat analysis was done maintaining
patients in their original groups, regardless of completion
of educational sessions, and assuming uncontrolled BP
(worst scenario) in those patients lost of follow up. The
STATA, version 8.0 (Stata Corporation, College Station,
TX) program was used to perform the statistical
analysis.

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EDUCATION AND BLOOD PRESSURE CONTROL IN ELDERLY PERSONS

AJHJuly 2006 VOL. 19, NO. 7

Table 2. Basal characteristics of study subjects

Variable

PEM (n 30)

CM (n 30)

P value

Age, mean (SD), years

Female, n (%)
Years of education
Mean body mass index, kg/m2 (SD)
Diabetes, n (%)
Tobacco, n (%)
Ex-smoker, n (%)
Cardiovascular diseases, n (%)
Dyslipidemia n (%)
Sedentary BP, n (%)
Systolic BP, mm Hg, mean (SD)
Diastolic BP, mm Hg, mean (SD)
24-h systolic BP mean (SD)
24-h diastolic BP mean (SD)
Daytime systolic BP mean (SD)
Daytime systolic BP mean (SD)
Night time systolic BP mean (SD)
Night time diastolic BP, mean (SD)
Basal BP control (140/90 mm Hg), n (%)
White coat hypertension, n (%)*
Masked hypertension, n (%)
Antihypertensive drugs, mean (SD)
Antihypertensive drugs use, n (%)
Diuretic (%)
-blocker (%)
Calcium antagonist (%)
ACE inhibitor (%)
Other (%)

67 (9)
17 (57)
6.3 (3.1)
31 (7)
7 (23)
3 (10)
18 (60)
13 (43)
18 (60)
20 (76)
157 (14)
88 (9)
140 (9)
83 (8)
144 (15)
86 (12)
132 (18)
74 (13)
13 (43)
5 (17)
2 (7)
1.6 (0.9)
58 (97)
13
22
10
33
1.6

70 (9)
9 (30)
5.8 (3.1)
30 (4)
10 (31)
0
13 (43)
13 (43)
22 (73)
15 (50)
156 (12)
88 (7)
143 (10)
83 (8)
145 (19)
85 (12)
129 (17)
72 (11)
12 (40)
7 (24)
3 (10)
1.5 (0.8)
59 (98)
20
15
3.3
35
3.3

0.22
.05
.82
.57
.39
.06
.19
.91
.19
.15
.78
.76
.77
.90
.97
.82
.42
.47
.79
.48
.61
.60
1
.33
.35
.27
.85
1

ACE angiotensin-converting enzyme; BP blood pressure; CM compliance-based model; PEM patient empowerment based model;
SD standard deviation.
* White coat hypertension: BP 140/90 mm Hg on basal office BP readings and 130/80 mm Hg on basal ambulatory BP monitoring
(ABPM).
Masked hypertension: ABPM minus office BP readings 10 mm Hg for systolic BP and 6 mm Hg for diastolic BP.
Number of persons taking type/number of persons taking any antihypertensive medications.

Ethics Approval
The protocol was approved by the hospital institutional
review board, and all patients gave written informed consent before attending the clinical assessment.

Results
A total of 60 patients entered the study. Of the 30 patients
in the PEM group, 29 completed all four educational
sessions. Of the 30 patients in the CM group, 28 completed all four sessions; five patients in the PEM group and
five in the CM group dropped out from final ABPM
because lack of comfort in performing their daily activities
(Fig. 1). Mean follow up was 97 (9) days.
Baseline characteristics of the sample (Table 2) were
evenly distributed between the groups with the exception
of sex. The groups did not differ significantly, either initially or at the final assessment, with regard to natriuresis
and kaliuresis and other biochemical markers (Tables 3
and 4).
Systolic BP fell in both groups over the study period.
The PEM group showed a significant reduction in 24-h

systolic BP of 8 mm Hg (95% CI 2 to 15, P .02),

whereas the CM group showed a drop of 3 mm Hg (95%
CI to 3 to 8, P .35). Final systolic BP was significant
lower in the PEM group (140 [14] v 132 [9.], P .021).
After subtracting the systolic BP change in CM group, the
net reduction in the PEM group was 6 (3 to 14; P .17).
The net reduction in diastolic BP was 3 mm Hg (P .30).
In the PEM group the night-time systolic BP was reduced by 8 mm Hg (95% CI 0.2 to 15, P .04), whereas
in the CM group it increased by 5 mm Hg (95% CI to 3 to
8, P .19), although the difference was not significant.
Differences in BP measured at the office, and outside
the office are shown in Table 4.
The final mean number of antihypertensive drugs was
similar in both groups (1.9 [0.8] v 1.7 [0.8], P .46).
There was a small nonsignificant increase in the number of
antihypertensive drugs in both groups. The mean (SD)
drug increase was as follows: PEM group, 0.20 (0.5) v CM
group 0.14 (5); P .44).
There were 21 (70%) patients in the PEM group who
controlled their BP and 13 (44.8%) in the CM group
(P .04).

AJHJuly 2006 VOL. 19, NO. 7

EDUCATION AND BLOOD PRESSURE CONTROL IN ELDERLY PERSONS

741

Table 3. Basal blood and urinary determinations

Variables

PEM (n 30)

CM (n 30)

P
value

Proteinuria/Creatinine Abnormal ratio, n (%)

24-h urine creatinine*
Creatinine, mg/dL
Total cholesterol, mg/dL*
LDL cholesterol, mg/dL*
HDL cholesterol, mg/dL
24-h sodium excretion mEq/day
24-h potassium excretion, mEq/day
K/Na ratio

4 (14)
1139 (347)
0.90 (0.20)
186 (40)
119 (34)
40 (9)
(n 17) 116 (75214)
(n 17) 57 (5173)
(n 17) 0.5 (0.5)

9 (29)
1294 (530)
0.85 (0.30)
188 (27)
125 (27)
43 (9)
(n 18) 121 (105164)
(n 18) 61 (4978)
(n 18) 0.5 (0.4)

.21
.50
.61
.85
.46
.22
.96
.89
.82

Abbreviations as in Table 2.
* Mean and standard deviation.
Median and 25th and 75th centiles.

The unadjusted odds ratio for BP control for the

PEM group was 4.85 (95% CI 1.74 to 13.4). The odds
ratio after adjustment for age, sex, diabetes, initial BP,
and changes in pharmacologic treatment was 3.7 (1.05
to 13.1) (Table 5).

Discussion
Our rigorously conducted, randomized, controlled trial of
an educational intervention based on a patient empowerment model (ie, PEM) in general practice versus a compliance-based model (CM) in elderly patients showed an
increase in BP control under the patient empowerment
model.
The reduction in BP became apparent in analysis of
24-h ABPM, whereas in isolated measures this difference
was lost. From the statistical point of view this could be

caused by higher dispersion of values of single determinations or by lack of power. From the biological point of
view, factors such as white-coat hypertension could explain this phenomenon.7
Night-time BP was more sensitive to the intervention
than daytime BP; this could reflect difference in underlying mechanisms of control during both periods of the
day. Left ventricular hypertrophy index correlated with
night-time systolic BP (r 0.51) more closely than
with daytime systolic BP (r 0.38).19
A systematic review of self-management education
programs showed a standardized effect size of 0.20 for
similar interventions. A standardized effect size is the
difference between two means (eg, treatment minus
control) divided by the standard deviation of the two
conditions. Effect sizes are especially important because

Table 4. Outcome measures, final measurements, and effect sizes

Variable
Total systolic BP, mean (SD)
Total diastolic BP, mean (SD)
Daytime systolic BP, (6:00 AM
to 8:00 PM) mean (SD)
Daytime diastolic BP, mean
(SD)
Night-time systolic BP, (8:01
PM to 5:59 AM) mean (SD)
Night-time diastolic BP, mean
(SD)
Systolic BP at program office,
mean (SD)
Diastolic BP, at program
office, mean (SD)
Sodium excretion
Potassium excretion
Patients with controlled BP, %

PEM

CM

Net
reduction*

95% CI

P value

132 (9)
78 (8)

140 (14)
81 (10)

6
3

3 to 14
8 to 2

.17
.30

136 (10)

142 (15)

5 to 12

.46

83 (10)

4 to 8

.49

134 (18)

12

2 to 22

.02

73 (11)

3 to 10

.12

152 (26)

149 (16)

9 to 12

.81

82 (10)
119 (84158)
60 (4983)
70%

84 (11)
130 (77173)
59 (4078)
44.8%

0
5
8

6 to 7
31 to 40
10 to 26

.91
.79
.39
.04

81 (8)
124 (12)
70 (9)

BP blood pressure; CI confidence interval, other abbreviations as in Table 2.

* Net reduction: difference of mean reduction in each group: (Basal, final) PEM (basal, final) CM.
Expressed as median and as 25th and 75th centiles.

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EDUCATION AND BLOOD PRESSURE CONTROL IN ELDERLY PERSONS

Study Limitations
The difficulties of conducting a pragmatic intervention
trial in primary care are well recognized.22,23 Both
groups were comparable in most baseline variables except for the proportion of women. This does not seem to
influence the results when analyzed in the multivariable
model (Table 5).
We were unable to recruit the sample needed according to our sample size calculation; this could explain

Differences in Systolic Blood Pressure

24 hs AMBP
144
142
140
138
136
134
132
130
128
126

Difference in Diastolic Blood Pressure

24 hs AMBP

142,6
140,29

140
PEM
CM
131,83

basal

final

mm Hg

they allow comparison of the magnitude of experimental treatments from one experiment to another.3 In our
study, we found a standardized effect size of 0.407,
showing a moderate effect on BP reduction.
Elderly patient are not usually included in self-management educational programs.3 In theory this kind of
educational model has been considered to be less effective in individuals with limited literacy or low socioeconomic level or in persons who are elderly.9,10
In a previous experience we found that our elderly
population reached a good level of knowledge under our
innovative methodology in regard to learning self-efficacy in hypertension.20 To implement the workshop we
took into account that elderly individuals usually need
longer periods of time for the learning process than their
younger counterparts.
As most trials in self-management had referred, we also
selected theories and strategies according to each objective,8 and we also selected few self-management targets
according to needs, values, and priorities of this population so as to make learning easier.9,11,21
Education can only reduce BP through changes in
personal behaviors. We have not directly measured
these changes except salt intake. Having done that
would probably have helped us to explain the way the
educational model worked. These are complex models,
and there is probably more than one way that education
works. We failed to find differences in natriuresis between groups, which could be explained by the low
baseline consumption of salt. Other unmeasured variables could have contributed to reduce BP such as
therapeutic adherence and physical activity.

mm Hg

742

84
83
82
81
80
79
78
77
76
75

82,96
82,5
81,08
PEM
CM
77,79

basal

final

FIG. 2 Mean differences in systolic and diastolic blood pressure by

24-h ambulatory blood pressure monitoring. Y-axis scale spans 2
mm Hg for systolic and 1 mm Hg for diastolic blood pressure.

why, despite achieving a greater-than-expected difference (8 mm Hg instead of the calculated 5 mm Hg), we

did not find a statistically significant difference. Our
dropout rate of 16% was similar to those reported in
other programs.3
The reductions in BP seen in both groups may have
been partly because of an accommodation effect from
repeated measurements; however this would not explain
differences between groups.24 With regard to the effect
of therapeutic changes on BP, the pragmatic nature of
this trial allowed the choice of medications to be decided by the physician (Fig 2). All changes were recorded, however, and there were no differences between
groups in the number or doses of pharmacologic
changes (Table 5).
Because of the above-mentioned issues, our study
may not be generalized to other populations. It is already known, from studies of other chronic conditions,
that high-quality care needs to be systematic and that
outcome tends to be better when quality assurance is
introduced on the basis of registration and planned
follow-up.25
In conclusion, this study suggests that a self-management, self-empowerment education model was significantly more effective in reducing and controlling BP
in elderly patients than was a model based on patient
compliance.

Acknowledgment
Table 5. Multivariable analysis for blood pressure
control
Variable

OR

95% CI

Sex
Age, years
Diabetes
Basal systolic
BP, mm Hg
Intervention
Treatment
changes

1.190
1.020
1.131

0.3374.207
0.9471.098
0.3004.272

.787
.603
.855

0.954
3.702

0.9091.001
1.04413.127

.054
.043

2.069

0.5407.921

.289

The authors thank Mercedes Soriano for her intellectual

help with this manuscript.

P value

BP blood pressure; CI confidence interval; OR odds ratio.

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