198 Original article

Home blood pressure telemonitoring improves hypertension

control in general practice. The TeleBPCare study
Gianfranco Paratia,b,c, Stefano Ombonid, Fabio Albinia, Lucia Piantonia,
Andrea Giulianoa,c, Miriam Reveraa,c, Miklos Illyese, Giuseppe Manciaa,b,c,
on behalf of the TeleBPCare Study Group

Background Self blood pressure monitoring at home may group B than in group A (9 vs. 14%, P < 0.05). Quality of life
improve blood pressure control and patients’ compliance tended to be higher and costs lower in group B.
with treatment, but its implementation in daily practice faces
difficulties. Teletransmission facilities may offer a more Conclusion Patients’ management based on home blood
efficient approach to long-term home blood pressure pressure teletransmission led to a better control of
monitoring. ambulatory blood pressure than with usual care, with a
more regular treatment regimen. J Hypertens 27:198–203
Methods Twelve general practitioners screened 391 Q 2009 Wolters Kluwer Health | Lippincott Williams &
consecutive uncontrolled mild–moderate hypertensive Wilkins.
patients (80% treated), 329 of whom (58 W 11 years, 54%
men) were randomized to either usual care on the basis of Journal of Hypertension 2009, 27:198–203
office blood pressure (group A, n U 113) or to integrated
care on the basis of teletransmitted home blood pressure Keywords: ambulatory blood pressure monitoring, antihypertensive
treatment, arterial hypertension, blood pressure control, home blood
(group B, n U 216). Twenty-four-hour ambulatory blood pressure monitoring, home blood pressure teletransmission, office blood
pressure monitoring was performed at baseline and after pressure, patients’ compliance, quality of life, self blood pressure
monitoring at home
6 months, during which treatment was optimized according
to either office (group A) or home (group B) blood pressure Abbreviations: ABP, Ambulatory Blood Pressure; DBP, Diastolic Blood
Pressure; HBPM, Home Blood Pressure Monitoring; SBP, Systolic Blood
values. We compared differences between groups in the Pressure
rate of daytime ambulatory blood pressure normalization
a
(<130/80 mmHg), need of treatment changes during follow- Department of Cardiology, San Luca Hospital, Istituto Auxologico Italiano,
b
Centro Interuniversitario di Fisiologia Clinica e Ipertensione, cDepartment of
up, quality of life scores, and healthcare costs. Clinical Medicine and Prevention, University of Milano-Bicocca, Milan, dItalian
Institute of Telemedicine, Varese, Italy and eTensiomed Ltd, Budapest,
Hungary
Results Baseline office blood pressures were 149 W 12/
89 W 9 and 148 W 13/89 W 7 mmHg in groups A (n U 111) Correspondence to Gianfranco Parati, MD, Department of Cardiology, San Luca
Hospital, University of Milano-Bicocca and Istituto Auxologico Italiano, via
and B (n U 187) respectively, the corresponding daytime Spagnoletto 3, Milan 20149, Italy
values being 140 W 11/84 W 8 and 139 W 11/84 W 8 mmHg. Tel: +39 02 619112949/890; fax: +39 02 619112712/956;
e-mail: gianfranco.parati@unimib.it
The percentage of daytime blood pressure normalization
was higher in group B (62%) than in group A (50%) Received 30 May 2008 Revised 11 August 2008
(P < 0.05). There were less frequent treatment changes in Accepted 21 August 2008

Introduction as well as the difficulty for the physician to reach appro-

Self home blood pressure monitoring (HBPM) has a priate diagnostic conclusions from evaluation of often
number of potential advantages in the management of badly hand-written patients’ BP reports. Indeed, it has
hypertension [1]. These advantages include avoidance of been reported that in 54% of the cases, general prac-
the ‘white-coat effect’, availability of multiple BP read- titioners (GPs) fail to draw any meaningful conclusion out
ings over a wide time window, evaluation of the effects of patients’ BP log books [5].
of treatment on BP at different times of the day, and
improvement in patients’ adherence to therapy [1,2]. Progress in technology over the last few years has led to
However, this approach also has potential drawbacks that the availability of a number of systems for digital storage
can make its current implementation difficult in the of HBPM data and for their teletransmission to remote
clinical practice. These include the use of nonvalidated sites [6]. Some observations have suggested that a com-
devices, need of patient’s training, the risk of patients bination of HBPM with teletransmission facilities may
becoming neurotically obsessed by the procedure, not remove some of the inconveniences related to HBPM
infrequently with self-modifications of the prescribed alone, allowing better clinical results to be achieved [7,8].
antihypertensive treatment [3], and the possibility of The aim of our study was to address this issue more
an inaccurate report of home BP values by patients [4] specifically and to assess the impact of HBPM and data
0263-6352 ß 2009 Wolters Kluwer Health | Lippincott Williams & Wilkins DOI:10.1097/HJH.0b013e3283163caf

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 Home blood pressure teletransmission Parati et al. 199

teletransmission (TeleBPCare) on the achievement of measured by the physician at the time of the visits
ambulatory blood pressure (ABP) control by hypertensive through the same automated device used for home BP
patients followed in general practice. measurement in the other group (see below). Group B
(TeleBPCare group, 216 patients) was assigned to a
Methods management based on HBPM combined with teletrans-
Study design mission of home self-measured BP values in between the
This was a multicenter, open-label, randomized, con- scheduled clinic visits. In this group, treatment was
trolled, parallel group study that included 12 primary titrated to reduce home BP to less than 135/85 mmHg
care physicians operating in the Milan area (Italy) and was [10]. In both groups, the rate of BP control was deter-
aimed at demonstrating the ability of HBPM data tele- mined by the number of patients who achieved a daytime
transmission as compared with usual care based on office average ABP value of less than 130/80 mmHg at the end
BP measurements only, to obtain a higher rate of ABP of the follow-up period. In order to achieve the treatment
normalization, defined as a daytime average systolic BP goals, physicians were allowed to prescribe any anti-
blood pressure (SBP) less than 130 mmHg and diastolic hypertensive drug or drug combination they regarded as
blood pressure (DBP) less than 80 mmHg. We did not clinically appropriate [9].
plan to include an HBPM group without telemonitoring
to keep the study design as simple as possible (given Study procedures
its implementation in a general practice setting) and All patients were subjected to at least five office visits: at
because comparisons between patients’ management screening (visit one), at randomization (visit two, after
based on ‘regular’ HBPM or office BP measurements 1 week), and during follow-up (visits three to five, after
have already been made in previous studies (see below). 4, 12, and 24 weeks, respectively). At inclusion, the
patient’s history was taken, combined with a physical
Patients and sample size examination and two BP measurements at a 5 min interval
On the basis of the expectation of a 15% difference in the using the validated oscillometric device that had to be used
number of patients reaching average daytime ABP nor- for HBPM (Tensiophone device; Tensiomed, Budapest,
malization in favour of the group randomized to HBPM Hungary). The software of this device was validated
and telemonitoring as compared with the control group, a according to the International Protocol recommended
minimum number of 288 patients were required to guar- by the European Society of Hypertension Working Group
antee a power of 80% and a minimum level of significance on BP monitoring [11]. The device is equipped with a
of 0.05. Three hundred and ninety-one hypertensive built-in modem permanently plugged to the house phone
patients, consecutively seen in the GPs’ offices, were line and subjected to remote programming of the fre-
screened for inclusion in the study. Inclusion criteria quency of measurements as well as of the time of a
were an age between 18 and 75 years, a diagnosis of telereminding beep, which can be sent to the patient to
uncontrolled essential hypertension, as defined by the stimulate adherence to measurement schedule whenever
occurrence of an office SBP of at least 140 mmHg or DBP appropriate. Self-monitored BP values were regularly
of at least 90 mmHg and by an ambulatory mean daytime transmitted to a referral centre where data were checked
SBP of at least 130 mmHg or DBP of at least 80 mmHg and stored in a digital database. Values exceeding upper
(regardless of whether patients were or were not treated). and lower predefined arbitrary safety thresholds (180/110
Exclusion criteria were a diagnosis of secondary hyper- and 100/60 mmHg, respectively) triggered an alarm, on the
tension; major systemic diseases; atrial fibrillation or basis of which a dedicated trained nurse called the patient
frequent cardiac arrhythmias or severe atrioventricular at home to check his/her clinical status and the possibility
block, that is, conditions that could make HBPM and of artefactual measurements. Whenever needed, the phys-
ABP measurements unreliable; obesity (BMI >30 kg/m2) ician in charge was immediately alerted, and an additional
or an arm circumference of more than 32 cm or both, to office visit was scheduled. At each of the subsequent visits,
avoid inaccuracies in automated BP readings due to arm– BP was measured according to the same procedure, and
cuff mismatch; and any condition that might prevent information was obtained on adverse events and the
patients’ participation in the study, for example, tech- occurrence of changes in the treatment regimen made
nical problems due to incompatible phone lines at home. by the patient. In patients randomized to TeleBPCare,
information was also obtained on the patients’ compliance
Study groups with HBPM using the data available at the call centre.
Three hundred and twenty-nine out of the screened 391 This information was sent to the GPs together with the
patients (age, 58
11 years; 54% men) fulfilled the study processed HBPM data by regular mail, fax, or e-mail
inclusion/exclusion criteria and were randomized at an immediately before any scheduled office visit.
approximate 1 : 2 ratio into two groups. Group A (control
group, 113 patients) was assigned to an office BP-based In each patient, additional measurements included
management, treatment being aimed at reducing office hematochemistry values; an ECG; two 24-h ABP mon-
BP to less than 140/90 mmHg [9]. Office BP values were itorings (randomization and study end) by means of a

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 200 Journal of Hypertension 2009, Vol 27 No 1

Table 1 Demographic and clinic characteristics of patients at baseline

Control group (N ¼ 111) TELE HBPM (N ¼ 187) P

Age, mean
SD (years) 58.1
10.8 57.2
10.7 0.490

Men, n (%) 60 (54.1) 102 (54.5) 0.934
BMI, mean
SD (kg/m2) 26.9
3.6 26.9
4.1 0.949
Treated hypertensive patients, n (%) 85 (76.6) 148 (79.1) 0.604
Clinic SBP, mean
SD (mmHg) 148.7
11.7 148.4
12.6 0.820
Clinic DBP, mean
SD (mmHg) 88.8
8.6 88.7
7.4 0.918
Daytime SBP, mean
SD (mmHg) 140.3
10.5 139.4
11.0 0.508
Daytime DBP, mean
SD (mmHg) 84.3
8.2 83.9
8.0 0.640

DBP, diastolic blood pressure; SBP, systolic blood pressure; TELE HBPM, teletransmission of home blood pressure monitoring values.

validated oscillometric device (Tensioday, Tensiomed) Results

[11] using the same hardware components and software as Table 1 shows that the baseline demographic and clinical
the Tensiophone device used for home and office BP characteristics of the 288 patients of the intention-to-treat
measurements; and a quality of life score, assessed by the population were similar in the two groups. Treatment
administration of a modified short form-12 questionnaire induced a clear reduction in daytime ABP in both groups,
[12] at randomization and at the end of follow-up. Infor- but the percentage of patients in whom daytime ABP was
mation on additional doctors’ visits as well as on treat- normalized by treatment was significantly greater in the
ment changes between visits was also obtained from the group assigned to TeleBPCare than in the control group
electronic clinical chart. (Fig. 1). As shown in Fig. 2, daytime ABP recorded at the
end of the follow-up was also lower in the TeleBPCare
Endpoints and statistical analysis than in the control group, the difference being statisti-
The study primary endpoint was the percentage of cally significant for SBP, whereas the achieved office BP
patients who reached normalization of daytime ambulat- did not exhibit a significant between-group difference.
ory SBP and DBP (i.e. <130/80 mmHg) at the end of the This was also the case for the rate of office BP normal-
follow-up period. Secondary endpoints were the rate of ization (52% TeleBPCare vs. 53% control group). Con-
normalization of office and home SBP/DBP (the latter, by versely, in patients of the TeleBPCare group, rate of
protocol, only in group B), the frequency of treatment home BP normalization was very high (74% of patients),
changes originated either by the physician or by the with a persistent BP reduction during follow-up (Fig. 3).
patient, and the impact of the assigned management
system on the quality of life and healthcare costs. Health- As shown in Table 2, in the group randomized to HBPM
care costs were computed by considering the number of teletransmission, there was a nonsignificant trend towards
unscheduled additional visits, the number and type of a reduction in the number of additional diagnostic exam-
examinations prescribed, and the number and type inations prescribed by GPs. This was also the case for
of drugs prescribed during follow-up. Also, the costs of calculated healthcare costs, which also considered renting
renting of the TeleBPCare service for the duration of the
study were considered. Fig. 1

Out of these 329 patients, 288 patients, in whom all data

were available at the end of the study, were included in
the intention-to-treat analysis. Data analysis was carried
out by the SPSS for Windows software, version 11.5
(SPSS Inc., Chicago, Illinois, USA). Quantitative vari-
ables were described through the calculation of avera-
ge
SD values for each dataset. Discrete variables were
described by their absolute and relative frequency of
occurrence. Between-group differences were assessed
by analysis of variance for continuous variables and by
the chi-squared test of Mantzel–Haenszel for discrete
variables. The between-group comparison of the percen-
Percentage of patients with daytime normalization (SBP <130 mmHg
tage of patients with normalized ABP was made by chi- and DBP <80 mmHg). Data refer to the intention-to-treat population
squared test. Throughout the study, the level of statistical and to patients randomized to conventional management (control
significance was set at a P value of less than 0.05. Patients group, open bar, n ¼ 111) or teletransmission of home BP values (TELE
HBPM, striped bar, n ¼ 187). BP, blood pressure; DBP, diastolic blood
were included in the study after obtaining informed pressure; SBP, systolic blood pressure; TELE HBPM, teletransmission
consent. The study was approved by the Ethics Com- of home blood pressure monitoring values.
mittee of one of the institutions involved.

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 Home blood pressure teletransmission Parati et al. 201

Fig. 2 Fig. 3

Average (
SD) home systolic and diastolic blood pressure values

during the study in the patients randomized to teletransmission of home
BP values (n ¼ 187). BP, blood pressure; DBP, diastolic blood
pressure; SBP, systolic blood pressure; TELE HBPM, teletransmission
of home blood pressure monitoring values.

Discussion
In the patients of our study, self-measurement of BP at
home combined with teletransmission of the data so
obtained was associated with a significant increase in
the number of patient achieving ABP control at the
Average (
SD) office and daytime systolic blood pressure (a) and end of the study period as compared with the group
diastolic blood pressure (b) values at the end of the study in the
patients randomized to conventional management (control group, open randomized to traditional management. This provides
bars, n ¼ 111) or to teletransmission of home BP values (TELE HBPM, evidence that when self-measurements of BP are regu-
striped bars, n ¼ 187). BP, blood pressure; DBP, diastolic blood
pressure; SBP, systolic blood pressure; TELE HBPM, teletransmission larly and objectively transmitted to the physicians in
of home blood pressure monitoring values. charge of patients’ care, management of hypertensive
patients is definitively more successful. This is of obvious
clinical relevance because the low rate of BP control in
the hypertensive population represents a major health
costs of the TeleBPCare service for the duration of the problem [13] and a factor responsible for hypertension
study. Patients randomized to TeleBPCare were more being considered as one of the major causes of death and
adherent to the prescribed treatment schedule than the disease worldwide [14,15].
control group, as shown by the significantly lower rate of
treatment self-modification (Table 2). No significant Several other points of our study deserve to be men-
between-group differences were found in the rate of tioned. First of all, in our study, BP control was deter-
change in treatment regimens prescribed by the phys- mined by ABP monitoring which provides BP values
icians and in the quality of life assessment (Table 2). devoid of inconveniences such as the white-coat effect

Table 2 Additional diagnostic examinations, patient management costs, treatment modifications by physicians or patients, and quality of life
scores (Quality Of Life Assessment in Hypertensive Patients questionnaire) during the randomized study phase
Control group (N ¼ 111) TELE HBPM (N ¼ 187) P

Diagnostic examinations, n (%) 67 (20.1) 95 (16.9) 0.232

Diagnostic examinations per patient (mean
SD) 1.8
3.3 1.3
2.6 0.189
Cost of examinations (s, mean
SD) 7.31
21.30 5.83
12.76 0.451
Overall cost of patient management (s, mean
SD) 125.26
60.61 123.41
36.49 0.742
Treatment modification
By patients, n (%) 45 (13.5) 49 (8.7) 0.040
By physicians, n (%) 51 (15.3) 75 (13.4) 0.419
Quality of life
Baseline 38.2
4.5 37.7
4.8 0.502
End of study 38.3
5.4 38.4
4.6
End of study – baseline difference 0.1
3.9 0.7
4.3 0.273
End of study – baseline difference (%) 0.5
10.4 2.6
12.7 0.090

TELE HBPM, teletransmission of home blood pressure monitoring values.

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 202 Journal of Hypertension 2009, Vol 27 No 1

and the physicians’ bias affecting office BP measure- life scores, was not statistically significant, although
ments [16,17]. This adds to the reliability of our results, showing a trend towards an improvement in the tele-
the clinical implication of which is further reinforced by monitoring group. This might depend on the fact that
the fact that data were obtained in a general practice the sample size was estimated focusing on the primary
setting. Second, in our study, the advantage of combining endpoint only. The interest of demonstrating possible
self-measurement of BP at home with data teletransmis- favourable changes induced by telemonitorig also in
sion is supported by two additional findings. That is, in these parameters should thus stimulate additional
patients randomized to HBPM and teletransmission, the studies with a larger sample size.
percentage of treatment modifications by the patients
was significantly (35.6%, P < 0.05) less than in the Acknowledgements
control group, with a concomitant nonsignificant trend The authors wish to thank Mrs Ellen Tosazzi, in charge
towards a reduced number of requested diagnostic exam- of the TeleBPCare call centre, for her continuous support
inations and a better quality of life. Third, although the to patients and doctors involved in our study.
study design prevented a comparison with the control
group, home BP values were substantially reduced in the Research funds were obtained from our Institution along
group subjected to HBPM and teletransmission with a with an unrestricted research grant from Boehringer
high rate of BP control on the basis of upper normality Ingelheim, Italy.
values indicated by available hypertension guidelines
(74% of patients with home BP <135/85 mmHg) [9]. Data collection was carried our by the following general
This is also of clinical relevance because home BP has practitioners working in the Milan outskirts area: S.
recently been repeatedly found to have an important Andolfo, L. Angioni, S. Belforti, A.C. Bozzani, R.A.
prognostic value [18–22]. Ciminaghi, L. Cremagnani, A.A. Gimmelli, I. Miccolis,
C.M. Nicoli, R. Toscani, and R. Colajanni.
Our study has a few limitations. One, the design adopted
does not allow us to discriminate the role played by Dr Miklos Illyes is a scientific consultant for Tensiomed
HBPM per se and by HBPM combined with teletransmis- Ltd. There are no conflicts of interest.
sion facilities in obtaining a greater rate of BP control.
This would have needed comparison of BP control in References
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