Therapeutics

Effect of Education on BloodPressure Control in Elderly Persons

A Randomized Controlled Trial

Silvana Figar, Carlos Galarza, Erica Petrlik, Lucila Hornstein,Gabriela Rodrı́guez Loria, Gabriel Waisman, Marcelo Rada,Enrique Roberto Soriano, and Fernán González Bernaldo de Quirós

AJH 2006; 19:737–743

Background: It is not clear which educational strategyis most effective in helping patients to change their life-styles. This study compared the efficacy of two differenteducational models on reducing blood pressure (BP).

Methods: This was a randomized controlled trial inambulatory hypertensive patients �65 years of age. Work-shops that aimed to develop self-management and patientempowerment (PEM) were compared to workshops thatused a compliance-based model (CEM). The primary out-come was change in systolic BP at 3 months comparedwith basal values between groups (net reduction), mea-sured by 24-h ambulatory BP monitoring.

Results: A total of 30 patients were educated with PEMand 30 others with CM. Both groups were statisticallysimilar with regard to age (67 v 70 years), systolic BP (157v 156 mm Hg) and diastolic BP (88 v 88 mm Hg), diabetes

(23% v 31%), and basal natriuresis 116 v 121 mEq/day).

From the Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.

© 2006 by the American Journal of Hypertension, Ltd.Published by Elsevier Inc.

There were more women in the PEM group (57% v 30%).The PEM group showed a significant reduction of 8 mmHg (95% confidence interval [CI] 2 to 15), whereas theCM group showed a reduction of 3 mm Hg (95% CI �3to 8), with a net reduction of 6 (95% CI �3 to 14). Meannet night-time systolic BP reduction was 12 mm Hg (95%CI 2 to 22). BP control was 70% in PEM group vs 45% inCM group (P � 0.045). The relative odds ratio for BPcontrol for the PEM group after adjustment for age, sex,diabetes, basal blood pressure and changes in pharmaco-logical treatment was 3.7 (95% CI 1.05 to 13.1).

Conclusion: Based on these study results, the self-management education model was significantly moreeffective than the compliance-based model in BP con-trol. Am J Hypertens 2006;19:737–743 © 2006 Ameri-can Journal of Hypertension, Ltd.

Key Words: Hypertension, self-efficacy, elderly.

L ifestyle change is commonly assumed to be difficult toachieve, and self-management education interventionsoften have limited success in reducing behavioral risk

factors.1,2 Self-management education programs are hetero-geneous and there is evidence that their benefit in reducingblood pressure (BP) is relatively small.3 Such programs arenot usually used in elderly individuals because of the assump-tion that these individuals are unwilling to engage in health-promoting behaviors, although this presumption is notjustified.4

The most challenging issues in education involve helpingpatients to make long-term lifestyle changes. The basis of thepatient empowerment approach is to help patients to becomeresponsible for setting their own health care goals and toimplement the behavioral changes required to reach thesegoals.5

Received May 9, 2005. First decision October 14, 2005. AcceptedOctober 18, 2005.

According to current evidence, the way in which edu-cation is implemented could be important in helping pa-tients to make long-term, difficult lifestyle changes basedon partial evidence. Our health plan emphasizes the im-portance of empowering patients at high risk to makeeducated decisions regarding health and lifestyle, using apatient-empowerment model (PEM). The PEM approachaims at behavioral and beliefs changes that can sustainchanges over the course of time. More widely used, how-ever, is a compliance-based model (CM) that is based onmedical authority, with a paternal attitude from health careteam members. Physicians have traditionally give adviceon what to do to avoid dreaded health complications in thefuture.5,6 However, it has not been clear whether the PEMapproach is superior to traditional educational models, asboth require further study.

Address correspondence and reprint requests to Dr. Silvana Figar,Mons. Larumbe 3151, app. 734, Martinez, Buenos Aires (1640), Argen-

tina; e-mail: silvana.figar@hospitalitaliano.org.ar

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

738 AJH–July 2006–VOL. 19, NO. 7EDUCATION AND BLOOD PRESSURE CONTROL IN ELDERLY PERSONS

In addition, a gap has been found between office BPmeasurements and 24-h ambulatory BP monitoring(ABPM)7 This gap probably represents a white coat effectand suggests that, when defining hypertension treatmentsuccess, methods that do not involve the measurement ofBP by a physician should be considered.7

The aim of the study was to compare the efficacy of theself-management empowerment education model (PEM)with that of the compliance-based approach educationmodel (CM) on reducing BP measured by 24-ABPMamong elderly hypertensive patients. Theoretical and prac-tical differences in the two models are summarized inTable 1.

MethodsThis study was a pragmatic, blinded, and randomizedcontrolled trial with concealed allocation.

Study Population

Eligible patients were hypertensive affiliates of HealthMaintenance Organization of the Hospital Italiano. Allpatients were �65 years of age and were without dementia(based on a Mini-Mental test score �27), illiteracy, orsevere physical disability. All patients with therapeutic

Table 1. Differences between patient education m

Compliance-based model

Based on patients complying with what ahealth team member explains that isgood 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 thepatient and fear of complications

Paternal attitude from health team member;presentations usually based on graphsand figures

Content is organized according to risk factors

Examples of topics addressed

What is hypertension?Why is the patient hypertensive?

Impact on target organsChronic asymptomatic nature of disease

Advice on self-monitoring (frequency)Hyposodic diet (lists of high-sodium foods)Advice on high vegetable intakeAdvice on weight loss

changes in the 3 weeks before the study were excluded,

including those using diuretics, to avoid influence on na-triuresis. The study subjects were selected among patientsseen in the disease management program office whoagreed to participate in the study. The disease managementprogram at our hospital is a comprehensive, primary care–based program launched to reach all members withchronic disease.14

From these patients, the first two seen in the clinicevery day were included; thus 10 patients per week wereenrolled. The recruitment period lasted 6 weeks to reachthe sample size (Fig. 1). After 3 months a research assis-tant who had not previously been involved with the sub-jects and was therefore blinded to treatment allocationreassessed both groups.

s studied

Patient empowerment model

Based on development and enhancementof previously existing resources,

capacities, and knowledge; final aim isbehavioral change

Communicational issues:Message is patient-centeredEnhancement of perception of patient�s

abilitiesDevelop ways and mechanisms toachieve agreed-upon goals.

Motivation is centered on patient�s needs,stressing quality of life

Method requires patient commitment andparticipation; health team member is a“helper”

Treatment aims at risk factors that arecommon to prevalent conditions

Examples of topics addressed:Patient�s beliefs on source of

hypertensionNatural variability of the diseaseTips for cooking healthy food; cookingrecipes, provided by patients themselves

How to read and interpret food labelsBarriers to compliance with treatment and

ways to overcome them

84 potentially elegible

30 PEM 30 CM

60 Randomization 24 Not elegibles

29 attended educational sessions 25 with final 24 AMBP

28 attended educational sessions 25 with final 24 AMBP

FIG. 1 Flow chart of study subjects in trial comparing the effects onblood pressure control achieved through a patient empowermentmodel of education (PEM) versus a compliance-based model (CM) in

odel

elderly hypertensive patients. ABPM � ambulatory blood pressuremonitoring.

739AJH–July 2006–VOL. 19, NO. 7 EDUCATION AND BLOOD PRESSURE CONTROL IN ELDERLY PERSONS

Intervention

We designed an educational intervention that directlytargeted aspects of patients’ hypertension management,commonly referred to as a self-management interven-tion or patient empowerment approach.8 Our interven-tion included multiple theories and was tailored to ourpopulation according to Social and Educational Diag-nosis of predisposing, reinforcing, and enabling con-structs in educational diagnosis and evaluation(PRECEDE) model.8,9

The learning experiences had different instructionalstrategies that focused on the following: gaining attention(relative advantage of innovation and health benefits);introducing friendly material through empathy; taking intoaccount audience knowledge, values, needs, and self-effi-cacy; and introducing changes in lifestyle in an easy andpractical way. This can be achieved by training in skillssuch as group facilitation, problem solving, goal setting,and cognitive–behavioral techniques, which are not usu-ally part of training for most health care profession-als.10–12

The control workshop was based on the compliance-based model.13 This model assumes that patients shouldobey (ie, that they have an obligation to follow) the treat-ment recommendations of health care professionals; thusthis workshop gives information focusing on what patientsshould and should not do. The contents of both workshopswere based on hypertension management guidelines fromNational Institutes of Health and the American Heart As-sociation.14,15 Both workshops had four consecutive ses-sions of 2 h each and were given weekly to a group of 10patients.

Three intervention (PEM) and three control (CM)workshops were simultaneously given. The trainers werephysicians with significant experience in hypertension ed-ucation and management.16

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. Oncea patient arrived at the workshop the research assistant wasphoned by the monitor, just before the workshop began,and the patient was directed to the allocated room. Twodifferent physician educators concurrently offered theworkshops.

Primary care physicians were blinded to patient alloca-tion group. Referral to hypertension specialists was al-lowed to physicians other than the training educators.

The research monitor, who was also blinded to thepatients’ allocation groups and had no previous involve-ment with the trial, carried out the final clinical assess-

ment.

Sample Size

The sample size calculation was based on detecting asystolic BP difference between groups of 5 mm Hg ac-cording to our previous experience.17 We estimated thatcontrol group would have a 2–mm Hg reduction in thefinal ABPM.18 We calculated that 32 patients would berequired in each group to show significant difference at the5% level of probability and 80% power. To allow fordropouts we sought to recruit 84 patients.

Basal and Final Clinical Assessment

This included BP measurement (three measurements taken5 min apart with a digital BP device (OMROM-450 asdescribed elsewhere (OMRON Healthcare Inc., VernonHills, IL)).17

Twenty-Four-Hour Urine Collection forSodium and Potassium Urinary Excretion

All blood analyses were carried out in the same laboratory.Noninvasive ABPM was measured with a SpaceLabs auto-

matic device (model 900202; SpaceLabs, Redmond, WA).

Study Outcomes

The main study outcome was systolic BP measured by24-h ambulatory monitoring, measured as the mean dif-ference, and the BP control on final ABPM (defined as theproportion of patients with mean 24-h BP �140/90 mmHg). Diastolic BP measured by ABPM, office systolic anddiastolic BP readings, and natriuresis were also assessed assecondary outcomes.

Statistical Analysis

Normal continuous variables are expressed as mean(�SD) and compared with the t test for independentsamples. Non-normal continuous variables are expressedas median (25th to 75th centiles) and are compared usingthe Mann-Whitney statistic. The basal dichotomous vari-ables were compared using �2 analysis. Paired t tests wereused to compare BP differences within the PEM and CMgroups. Final systolic BP between groups was comparedwith independent t test. Basal and final 24-h natriuresisand kaliuresis excretion were analyzed with Wilcoxonsign-rank test. Logistic regression was used to compare theadjusted BP control rate between groups, age, sex, historyof diabetes, initial BP, and changes in pharmacologictreatment were the variables that best fit the model.

We expressed the net reduction as the difference inoutcome reduction between groups at a 95% confidencelevel. The intention to treat analysis was done maintainingpatients in their original groups, regardless of completionof educational sessions, and assuming uncontrolled BP(worst scenario) in those patients lost of follow up. TheSTATA, version 8.0 (Stata Corporation, College Station,TX) program was used to perform the statistical

analysis.

antih

740 AJH–July 2006–VOL. 19, NO. 7EDUCATION AND BLOOD PRESSURE CONTROL IN ELDERLY PERSONS

Ethics Approval

The protocol was approved by the hospital institutionalreview board, and all patients gave written informed con-sent before attending the clinical assessment.

ResultsA total of 60 patients entered the study. Of the 30 patientsin the PEM group, 29 completed all four educationalsessions. Of the 30 patients in the CM group, 28 com-pleted all four sessions; five patients in the PEM group andfive in the CM group dropped out from final ABPMbecause lack of comfort in performing their daily activities(Fig. 1). Mean follow up was 97 (�9) days.

Baseline characteristics of the sample (Table 2) wereevenly distributed between the groups with the exceptionof sex. The groups did not differ significantly, either ini-tially or at the final assessment, with regard to natriuresisand kaliuresis and other biochemical markers (Tables 3and 4).

Systolic BP fell in both groups over the study period.

Table 2. Basal characteristics of study subjects

Variable

Age, mean (SD), yearsFemale, n (%)Years of educationMean 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 (%)‡

ACE � angiotensin-converting enzyme; BP � blood pressure; CM �SD � standard deviation.

* White coat hypertension: BP �140/90 mm Hg on basal office(ABPM).

† Masked hypertension: ABPM minus office BP readings �10 mm‡ Number of persons taking type/number of persons taking any

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 significantlower in the PEM group (140 [14] v 132 [9.], P � .021).After subtracting the systolic BP change in CM group, thenet 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 re-duced by 8 mm Hg (95% CI 0.2 to 15, P � .04), whereasin the CM group it increased by 5 mm Hg (95% CI to 3 to8, P � .19), although the difference was not significant.

Differences in BP measured at the office, and outsidethe office are shown in Table 4.

The final mean number of antihypertensive drugs wassimilar in both groups (1.9 [0.8] v 1.7 [0.8], P � .46).There was a small nonsignificant increase in the number ofantihypertensive drugs in both groups. The mean (SD)drug increase was as follows: PEM group, 0.20 (0.5) v CMgroup 0.14 (5); P � .44).

There were 21 (70%) patients in the PEM group whocontrolled their BP and 13 (44.8%) in the CM group

(n � 30) CM (n � 30) P value

67 (9) 70 (9) 0.2217 (57) 9 (30) .05.3 (3.1) 5.8 (3.1) .8231 (7) 30 (4) .577 (23) 10 (31) .393 (10) 0 .06

18 (60) 13 (43) .1913 (43) 13 (43) .9118 (60) 22 (73) .1920 (76) 15 (50) .1557 (14) 156 (12) .7888 (9) 88 (7) .7640 (9) 143 (10) .7783 (8) 83 (8) .9044 (15) 145 (19) .9786 (12) 85 (12) .8232 (18) 129 (17) .4274 (13) 72 (11) .4713 (43) 12 (40) .795 (17) 7 (24) .482 (7) 3 (10) .61

.6 (0.9) 1.5 (0.8) .6058 (97) 59 (98) 113 20 .3322 15 .3510 3.3 .2733 35 .851.6 3.3 1

pliance-based model; PEM � patient empowerment–based model;

eadings and �130/80 mm Hg on basal ambulatory BP monitoring

for systolic BP and �6 mm Hg for diastolic BP.ypertensive medications.

PEM

6

1

1

1

1

1

com

BP r

Hg

(P � .04).

741AJH–July 2006–VOL. 19, NO. 7 EDUCATION AND BLOOD PRESSURE CONTROL IN ELDERLY PERSONS

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

DiscussionOur rigorously conducted, randomized, controlled trial ofan educational intervention based on a patient empower-ment model (ie, PEM) in general practice versus a com-pliance-based model (CM) in elderly patients showed anincrease in BP control under the patient empowermentmodel.

The reduction in BP became apparent in analysis of24-h ABPM, whereas in isolated measures this differencewas lost. From the statistical point of view this could be

Table 3. Basal blood and urinary determinations

Variables P

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† (n �24-h potassium excretion, mEq/day† (n �K/Na ratio† (n

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

Table 4. Outcome measures, final measurements,

Variable PEM

Total systolic BP, mean (SD) 132 (9)Total diastolic BP, mean (SD) 78 (8)Daytime systolic BP, (6:00 AM

to 8:00 PM) mean (SD) 136 (10)Daytime diastolic BP, mean

(SD) 81 (8)Night-time systolic BP, (8:01

PM to 5:59 AM) mean (SD) 124 (12)Night-time diastolic BP, mean

(SD) 70 (9)Systolic BP at program office,

mean (SD) 152 (26)Diastolic BP, at program

office, mean (SD) 82 (10)Sodium excretion† 119 (84–158)Potassium excretion† 60 (49–83)Patients with controlled BP, % 70%

BP � blood pressure; CI � confidence interval, other abbreviations

* Net reduction: difference of mean reduction in each group: (Basal,† Expressed as median and as 25th and 75th centiles.

caused by higher dispersion of values of single determi-nations or by lack of power. From the biological point ofview, factors such as white-coat hypertension could ex-plain this phenomenon.7

Night-time BP was more sensitive to the interventionthan daytime BP; this could reflect difference in under-lying mechanisms of control during both periods of theday. Left ventricular hypertrophy index correlated withnight-time systolic BP (r � 0.51) more closely thanwith daytime systolic BP (r � 0.38).19

A systematic review of self-management educationprograms showed a standardized effect size of 0.20 forsimilar interventions. A standardized effect size is thedifference between two means (eg, treatment minuscontrol) divided by the standard deviation of the twoconditions. Effect sizes are especially important because

(n � 30) CM (n � 30)P

value

4 (14) 9 (29) .219 (347) 1294 (530) .500 (0.20) 0.85 (0.30) .616 (40) 188 (27) .859 (34) 125 (27) .460 (9) 43 (9) .22116 (75–214) (n � 18) 121 (105–164) .96) 57 (51–73) (n � 18) 61 (49–78) .897) 0.5 (0.5) (n � 18) 0.5 (0.4) .82

effect sizes

CMNet

reduction* 95% CI P value

(14) 6 �3 to 14 .17(10) 3 �8 to 2 .30

(15) 3 �5 to 12 .46

(10) 2 �4 to 8 .49

(18) 12 2 to 22 .02

(11) 5 �3 to 10 .12

(16) 1 �9 to 12 .81

(11) 0 �6 to 7 .91(77–173) 5 �31 to 40 .79(40–78) 8 �10 to 26 .394.8% — — .04

Table 2.

EM

1130.918114

17)17

� 1

and

14081

142

83

134

73

149

8413059

4

as in

final) PEM � (basal, final) CM.

742 AJH–July 2006–VOL. 19, NO. 7EDUCATION AND BLOOD PRESSURE CONTROL IN ELDERLY PERSONS

they allow comparison of the magnitude of experimen-tal treatments from one experiment to another.3 In ourstudy, we found a standardized effect size of 0.407,showing a moderate effect on BP reduction.

Elderly patient are not usually included in self-man-agement educational programs.3 In theory this kind ofeducational model has been considered to be less effec-tive in individuals with limited literacy or low socio-economic level or in persons who are elderly.9,10

In a previous experience we found that our elderlypopulation reached a good level of knowledge under ourinnovative methodology in regard to learning self-effi-cacy in hypertension.20 To implement the workshop wetook into account that elderly individuals usually needlonger periods of time for the learning process than theiryounger counterparts.

As most trials in self-management had referred, we alsoselected theories and strategies according to each objec-tive,8 and we also selected few self-management targetsaccording to needs, values, and priorities of this popula-tion so as to make learning easier.9,11,21

Education can only reduce BP through changes inpersonal behaviors. We have not directly measuredthese changes except salt intake. Having done thatwould probably have helped us to explain the way theeducational model worked. These are complex models,and there is probably more than one way that educationworks. We failed to find differences in natriuresis be-tween groups, which could be explained by the lowbaseline consumption of salt. Other unmeasured vari-ables could have contributed to reduce BP such astherapeutic adherence and physical activity.

Study Limitations

The difficulties of conducting a pragmatic interventiontrial in primary care are well recognized.22,23 Bothgroups were comparable in most baseline variables ex-cept for the proportion of women. This does not seem toinfluence the results when analyzed in the multivariablemodel (Table 5).

We were unable to recruit the sample needed accord-ing to our sample size calculation; this could explain

Table 5. Multivariable analysis for blood pressurecontrol

Variable OR 95% CI P value

Sex 1.190 0.337–4.207 .787Age, years 1.020 0.947–1.098 .603Diabetes 1.131 0.300–4.272 .855Basal systolic

BP, mm Hg 0.954 0.909–1.001 .054Intervention 3.702 1.044–13.127 .043Treatment

changes 2.069 0.540–7.921 .289

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

why, despite achieving a greater-than-expected differ-ence (8 mm Hg instead of the calculated 5 mm Hg), wedid not find a statistically significant difference. Ourdropout rate of 16% was similar to those reported inother programs.3

The reductions in BP seen in both groups may havebeen partly because of an accommodation effect fromrepeated measurements; however this would not explaindifferences between groups.24 With regard to the effectof therapeutic changes on BP, the pragmatic nature ofthis trial allowed the choice of medications to be de-cided by the physician (Fig 2). All changes were re-corded, however, and there were no differences betweengroups in the number or doses of pharmacologicchanges (Table 5).

Because of the above-mentioned issues, our studymay not be generalized to other populations. It is al-ready known, from studies of other chronic conditions,that high-quality care needs to be systematic and thatoutcome tends to be better when quality assurance isintroduced on the basis of registration and plannedfollow-up.25

In conclusion, this study suggests that a self-man-agement, self-empowerment education model was sig-nificantly more effective in reducing and controlling BPin elderly patients than was a model based on patientcompliance.

AcknowledgmentThe authors thank Mercedes Soriano for her intellectualhelp with this manuscript.

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140,29

131,83

142,6

140

126

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basal f inal

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