Int J Clin Exp Med 2014;7(11):4369-4377
www.ijcem.com /ISSN:1940-5901/IJCEM0002332
Original Article
Development and evaluation of a
nurse-led hypertension management model
in a community: a pilot randomized controlled trial
Xuejiao Zhu1,2, Frances Kam Yuet Wong1, Lai Har Wu1
1
School of Nursing, The Hong Kong Polytechnic University, Hong Kong Special Administrative Region, P. R. China;
2
Hangzhou Normal University, Hangzhou 310018, Zhejiang, P. R. China
Received September 4, 2014; Accepted September 19, 2014; Epub November 15, 2014; Published November 30,
2014
Abstract: This study aims to develop a nurse-led hypertension management model in the community setting and
pilot it to an experimental trial. A total of 73 recruited participants were randomly allocated into two groups. The
study group received a home visit and 2-4 telephone follow-ups from the trained community nurses assisted by
nursing student volunteers. The control group received doctor-led hypertension management. Data was collected
at recruitment and immediately after the 8-week program. Outcome measures included blood pressure readings,
self-care adherence, self-efficacy, quality of life, and patient satisfaction. Participants from the study group led by
nurses had significant improvement in self-care adherence, patient satisfaction post-intervention than those from
the control group led by doctors. However, there were no statistical significant differences in blood pressure read-
ings, quality of life and self-efficacy between the two groups. The findings show that the nurse-led hypertension
management appears to be a promising way to manage hypertensive patients at the community level, particularly
when the healthcare system is better integrated.
Keywords: Community, hypertension management, nurse-led, pilot study, randomized controlled trial
Introduction that interdisciplinary team-based care involving
such professionals as nurses can exert positive
Hypertension has a high prevalence rate and effects on hypertension management [9].
low control rate worldwide. Finding a way to Studies on nurse-led care show higher patient
improve blood pressure (BP) control is a major adherence and satisfaction rates compared
challenge. Anti-hypertensive drugs and life- with doctor-led care in the primary care setting,
style modifications are well recognised as with similar effects on mortality and quality of
effective BP control measures, and are thus life (QoL) [10, 11]. The intervention strategies in
recommended in the guidelines of many coun- successful nurse-led hypertension care pro-
tries and regions [1-7]. Unfortunately, the rates grammes include counselling and health edu-
of adherence to the BP control measures and cation [12-18], and self-management such as
implementation of the guidelines remain low BP monitoring [12, 13, 16-18]. Compared with
[5, 8]. Effective hypertension management pharmacological treatment, these nurse-led
should therefore incorporate essential ele- non-pharmacological intervention strategies
ments to improve patient adherence. In con- are lower in cost but can contribute to reducing
ventional medical treatment, physicians play a systolic blood pressure (SBP) by 4.8 mmHg [9].
primary role in BP control. However, physicians Nurse-led intervention has thus been suggest-
are more likely to focus on pharmacological ed as a promising way to manage hypertensive
treatment and overlook the strategies for BP patients, although it lacks consistent interna-
control, such as interventions that involve life- tional evidence. Accordingly, researchers [19,
style modifications and the provision of struc- 20] have called for further evaluation of nurse-
tured follow-ups to monitor the effects of treat- led cares efficacy in hypertension manage-
ment or intervention. There is evidence to show ment. As Clark et al. [20] point out, since the
Nurse-led hypertension management
existing evidence comes mostly from the United The study group received nurse-led hyperten-
States, it is necessary to obtain hypertension sion management designed on the basis of the
management evidence from other countries 4-C (comprehensiveness, collaboration, coordi-
and regions. nation, and continuity) framework developed by
Wong et al. [21]. Comprehensiveness was
In this study, a randomized controlled trial (RCT) assured in patient assessment and health doc-
was conducted to develop, and experimentally umentation by using the Omaha System [22].
evaluate the effects of a model designed to Its use allowed patients health problems in the
guide the practice of nurse-led hypertension environmental, psychosocial, physiological and
management in the community. The prelimi- health-related behaviours domains to be asse-
nary nurse-led hypertension management mo- ssed, and the results of all assessments, inter-
del was tested in practice, thereby providing vention implementation and changes in health
evidence of and valuable insights into its feasi- condition to be recorded systematically and
bility and efficacy. The study has examined the dynamically. Collaboration was assured by hav-
difference in BP reading, self-care adherence, ing the trained community nurses work with
self-efficacy, QoL and patient satisfaction other team members such as general practitio-
between patients who received care guided by ners, nursing student volunteers, coordinator
the nurse-led hypertension management mo- and the patients themselves to manage the lat-
del and those who received care guided by doc- ters health condition. Coordination involved
tor-led hypertension management. the trained community nurses organising and
facilitating available resources to meet pati-
Materials and methods ents needs. The trained community nurses
provided home visits. After the home visit, the
Enrolment of participants in RCT trained community nurse and a nursing student
volunteer provided follow-up for every patient
The RCT study was conducted in a community by telephone, thereby enhancing the effects of
health centre (CHC) in Hangzhou, China, with intervention. Two monthly telephone follow-ups
73 participants recruited (36 in the study group were provided to those whose BP at recruit-
and 37 in the control group). Ethical approval ment was lower than 140/90 mmHg. Four
was obtained from the CHC involved in the biweekly telephone follow-ups were provided to
study. All information was provided to the par- those whose BP at recruitment was 140/90
ticipants in written form. Signed consent forms mmHg or higher. These interventions and the
were obtained from all participants. The inclu- training offered to the community nurses were
sion criteria for study participation were: (a) a based on protocols developed with reference to
diagnosis of hypertension, (b) 35 years old guidelines [23], literature review [16] and
and (c) living within the health service network expert consultation.
of the CHC. The exclusion criteria were: (a)
Effects of interventions
inability to communicate, (b) inability to be con-
tacted by phone, (c) terminal illness, (d) co-mor- The outcome measures included systolic blood
bidities in contradiction with the intervention pressure (SBP) and diastolic blood pressure
programme (e.g. exercise) and (e) pregnancy. (DBP), self-care adherence, self-efficacy, QoL,
and patient satisfaction. SBP and DBP were
Interventions
measured twice using a calibrated YUYUE
sphygmomanometer, with patients average BP
The study involved an 8-week intervention. The
readings recorded [23] by the research assis-
control group in the study received hyperten-
tants, who also collected the remainder of the
sive care guided by the traditional doctor-led
outcomes through patient self-reports during
model. Such care included unstructured and
face-to-face interviews carried out in the outpa-
irregular follow-ups with pharmacological treat-
tient department of the CHC.
ment by general practitioners. These follow-ups
occurred when patients visited general practi- Self-care adherence was measured using the
tioners to get supplemental medicines in the adherence form adopted in previous studies
centre. The control group received health edu- [16, 21], which includes adherence to smoking
cation leaflets published by local department cessation, alcohol restriction, salt restriction,
and the bimonthly health education lectures regular physical activity, home blood pressure
provided by the centre. monitoring (HBPM) and the use of anti-hyper-
4370 Int J Clin Exp Med 2014;7(11):4369-4377
Nurse-led hypertension management
Figure 1. Patient allocation and experimental design.
tensive drugs. For smoking cessation and alco- possible health status) to 100 (best possible
hol restriction, a score of 2 was given for adher- health status). In this study, the questionnaires
ence and a score of 1 for non-adherence. With Cronbachs alpha coefficient ranged from 0.71
respect to the remainder of adherence, a score to 0.94.
of 3 was assigned for complete adherence, 2
for partial adherence and 1 for non-adherence. Patient satisfaction was measured using a
A high rate of inter-rater reliability, i.e. 0.92, was scale modified from the Patients Satisfaction
achieved for this measure. Scale employed by Wong et al. [21]. The modi-
fied scale contains ten items, ranked on a
Participants self-efficacy was measured using 6-point scale (5 = very satisfactory, 4 = satis-
the Chinese version of the Short-form Chronic factory, 3 = fair, 2 = unsatisfactory, 1 = very
Disease Self-Efficacy Scale (CDSES) [24]. The unsatisfactory, 0 = not applicable). The scales
CDSES includes six items, each of which is Cronbachs alpha coefficient in this study was
rated on a scale ranging from 1 (not at all confi- 0.92.
dent) to 10 (totally confident). The scales
Cronbachs alpha coefficient in this study was Data analyses
0.82.
All data were recorded and analysed using the
QoL was measured using the Chinese version Statistical Package for the Social Sciences, ver-
of the Short-Form Health Survey (SF-36) [25]. sion 17.0. Baseline data were compared using
The SF-36 includes eight domains of functional a chi-square test for categorical data and inde-
status: physical functioning, role-physical, bodi- pendent t-tests for continuous data. A paired
ly pain, general health, vitality, social function- t-test was used for BP readings, self-efficacy,
ing, role-emotional and mental health. The and QoL to test for within-groups differences
score for each domain ranges from 0 (worst and an independent t-test to test for between-
4371 Int J Clin Exp Med 2014;7(11):4369-4377
Nurse-led hypertension management
Table 1. Comparison of the characteristics of the two groups (n = 73)
Total Study group Control group
Variable 2/t-test (p value)
n = 73 (%) n = 36 (%) n = 37 (%)
Sex
Male 27 (36.99) 15 (41.67) 12 (32.43) 0.67* (0.472)
Female 46 (63.01) 21 (58.33) 25 (67.57)
Educational level
No formal education 9 (12.32) 5 (13.89) 4 (10.81) 3.96* (0.139)
Primary education or below 14 (19.18) 10 (27.78) 4 (10.81)
Secondary education or above 50 (68.49) 21 (58.33) 29 (78.38)
Living status
Live alone 10 (13.70) 5 (13.89) 5 (13.51) 0.00* (1.000)
Live with others 63 (86.30) 31 (86.11) 32 (86.49)
Marital status
Married 49 (67.12) 24 (66.67) 25 (67.57) 0.01* (1.000)
Single 24 (32.88) 12 (33.33) 12 (32.43)
Income
Below average 61 (83.56) 29 (80.56) 32 (86.49) 0.41* (0.750)
Average or above 12 (16.44) 7 (19.44) 5 (13.51)
Age (years)
Mean (SD) 69.13 (9.72) 70.42 (10.63) 67.81 (8.82) 1.13# (0.262)
[Range] [47-89] [47-89] [51-84]
Co-morbidity
No co-morbidity 17 (23.29) 7 (19.44) 10 (27.03) 0.59* (0.581)
One or more co-morbidities 56 (76.71) 29 (80.56) 27 (72.97)
Body mass index
Mean (SD) 24.56 (2.89) 24.33 (2.82) 24.89 (2.91) -1.46# (0.146)
[Range] [16.24-32.53] [16.22-29.34] [20.42-32.53]
Waist circumference
Mean (SD) 86.54 (9.32) 86.46 (8.99) 86.53 (9.45) -0.09# (0.927)
[Range] [64-123] [64-108] [66-123]
Note: *, Chi-square test; #, Independent sample t-test.
group differences. A Wilcoxon signed-rank test the 15 participants were analyzed by the inten-
was used to compare self-care adherence and tion-to-treat analysis according to previous
patient satisfaction pre- and post-intervention, report [26]. The patient allocation is illustrated
and a Mann-Whitney U-test was performed to in Figure 1. There were no statistically signifi-
compare the ranked scores between the two cant differences between the demographic and
groups. Missing data were replaced by last health characteristics of the patients who
observation values according to previously dropped out and those who completed the
reported method [26], and the intention-to- study. The participants in the study and control
treat analysis was performed. Two-tailed p val- groups received nurse-led and doctor-led
ues of < 0.05 were considered significant. hypertension managements, respectively.
Results Table 1 presents the participants demographic
Demographic and health characteristics and health characteristics. It can be seen that
the majority of the participants were female
Of the 73 participants recruited (36 in the study (46, 63.0%). The mean age was 69.1 (SD = 9.7;
group and 37 in the control group) in this RCT range = 47-89) and more than half (68.5%) had
study, 15 (eight in the study group and seven in a secondary school or above level of education.
the control group) were lost to follow-up or dis- In addition, the majority of participants (76.7%)
continued the programme. Results relative to had one or more co-morbidities, with a mean
4372 Int J Clin Exp Med 2014;7(11):4369-4377
Nurse-led hypertension management
Table 2. Comparison of the blood pressure readings of the two groups (n = 73)
Study group n = 36 Control group n = 37 Independent t-test
Mean (SD) Mean (SD) t value p value
Systolic blood pressure
Pre-test 130.92 (10.14) 131.95 (11.67) -0.401 0.689
Post-test 130.83 (9.94) 132.24 (13.86) -0.498 0.620
Paired t-test, t, p-value 0.069, 0.945 -0.128, 0.899
Diastolic blood pressure
Pre-test 74.31(6.23) 76.05 (8.10) -1.032 0.306
Post-test 72.75 (6.64) 75.35 (6.86) -1.646 0.104
Paired t-test, t, p-value 1.324, 0.194 0.587, 0.561
Table 3. Comparison of self-care adherence between the two groups (n = 73)
Study group Control group
Mann-Whitney U-test
n = 36 n = 37
Variables
Median Median
Z value p value
(Interquartile Range) (Interquartile Range)
Smoking cessation
Pre-test 2 (2-2) 2 (2-2) -0.433 0.665
Post-test 2 (2-2) 2 (2-2) -0.433 0.665
Wilcoxon signed-rank test, Z, p-value 0.000, 1.000 0.000, 1.000
Alcohol restriction
Pre-test 2 (2-2) 2 (2-2) -0.052 0.959
Post-test 2 (2-2) 2 (2-2) -0.723 0.470
Wilcoxon signed-rank test, Z, p-value 0.000, 1.000 -1.000, 0.317
Salt restriction
Pre-test 2 (1-2) 2 (1-2) -0.588 0.557
Post-test 3 (2-3) 2 (1-2) -2.366 0.018
Wilcoxon signed-rank test, Z, p-value -2.357, 0.018 -0.235, 0.814
Regular physical activity
Pre-test 2 (2-3) 2 (2-2) -0.751 0.453
Post-test 2 (2-3) 2 (2-2) -1.185 0.236
Wilcoxon signed-rank test, Z, p-value -0.504, 0.614 -0.000, 1.000
Home blood pressure monitoring
Pre-test 3 (2-3) 2 (2-3) -0.536 0.592
Post-test 3 (2-3) 2 (2-3) -3.101 0.002
Wilcoxon signed-rank test, Z, p-value -2.646, 0.008 -1.000, 0.317
Use of anti-hypertensive drugs
Pre-test 2 (1-3) 2 (1-3) -1.042 0.297
Post-test 3 (3-3) 2 (1-3) -4.626 0.000
Wilcoxon signed-rank test, Z, p-value -4.179, 0.000 -1.265, 0.206
body mass index (BWI) of 24.6 (SD = 2.9) and a Self-care adherence
mean waist circumference (WC) of 86.5 (SD =
9.3). There were no statistically significant dif- Although the two groups had equivalent adher-
ferences between the study and control groups ence scores (Table 3), the study group dis-
at baseline data. No statistically significant dif- played significant improvements in salt restric-
ferences in the participants BP readings (Table tion (Z = -2.357, p = 0.018), HBPM (Z = -2.646,
2) were found between the two groups after the p = 0.008) and drug use (Z = -4.179, p = 0.000)
8-week intervention. post-intervention. These results suggest that
4373 Int J Clin Exp Med 2014;7(11):4369-4377
Nurse-led hypertension management
Table 4. Comparison of self-efficacy between the two groups (n = 73)
Study group n = 36 Control group n = 37 Independent t-test
Variable
Mean (SD) Mean (SD) t value p value
Pre-test 6.20 (1.93) 5.77 (1.98) 0.957 0.342
Post-test 6.73 (1.63) 5.87 (2.18) 1.904 0.061
Paired t-test, t value (p value) -1.497 (0.143) -0.306 (0.761)
Table 5. Comparison of quality of life between the two groups (n = 73)
Study group n = 36 Control group n = 37 Independent t-test
Variables
Mean (SD) Mean (SD) t value p value
Physical functioning
Pre-test 85.56 (12.86) 84.05 (16.62) 0.431 0.668
Post-test 84.03 (16.12) 82.84 (19.49) 0.285 0.777
Paired t-test, t, p-value 0.544, 0.590 0.367, 0.716
Role physical
Pre-test 68.75 (41.99) 74.32 (42.28) -0.565 0.574
Post-test 67.36 (42.18) 78.38 (38.26) -1.169 0.246
Paired t-test, t, p-value 0.158, 0.875 -0.498, 0.621
Bodily pain
Pre-test 74.78 (19.14) 72.86 (26.14) 0.357 0.722
Post-test 75.58 (23.99) 75.78 (23.61) -0.036 0.971
Paired t-test, t, p-value -0.201, 0.842 -0.564, 0.576
General health
Pre-test 46.53 (11.57) 49.89 (22.24) 1.237 0.220
Post-test 55.94 (19.43) 46.22 (12.81) 2.532 0.014
Paired t-test, t, p-value 2.515, 0.017 0.818, 0.419
Vitality
Pre-test 71.11 (13.94) 72.70 (17.50) -0.429 0.669
Post-test 72.78 (15.65) 75.95 (14.57) -0.896 0.374
Paired t-test, t, p-value -0.634, 0.530 -1.366, 0.180
Social functioning
Pre-test 85.42 (16.77) 91.55 (12.17) -1.786 0.079
Post-test 85.76 (16.13) 88.51 (20.49) -0.636 0.527
Paired t-test, t, p-value -0.133, 0.895 0.893, 0.378
Role emotional
Pre-test 74.07 (41.49) 79.28 (36.30) -0.571 0.570
Post-test 73.15 (41.27) 81.08 (36.47) -0.871 0.387
Paired t-test, t, p-value 0.122, 0.903 -0.264, 0.793
Mental health
Pre-test 79.89 (17.12) 85.84 (11.22) -1.751 0.085
Post-test 83.56 (13.62) 87.68 (10.77) -1.432 0.157
Paired t-test, t, p-value -1.162, 0.253 -0.954, 0.347
8-week nurse-led intervention program can Patient self-efficacy
effectively enhance patients adherence to
both prescriptions of anti-hypertensive drugs As given in Table 4, there was a slight increase
and recommendations of lifestyle modifica- in the mean score of patient self-efficacy in the
tions such as salt restriction. study group after intervention in comparison
4374 Int J Clin Exp Med 2014;7(11):4369-4377
Nurse-led hypertension management
Table 6. Comparison of patient satisfaction between the two groups (n=73)
Study group Control group
Mann-Whitney U-test
n = 36 n = 37
Median Median
Z value p value
(Interquartile Range) (Interquartile Range)
Pre-test 35.50 (0.00-48.00) 34.00 (0.00-40.00) -0.583 0.560
Post-test 40.00 (24.00-49.00) 32.00 (0.00-40.00) -2.054 0.040
Wilcoxon sinned ranks test, Z value (p value) -2.303, (0.021) -0.430, (0.667)
with the control group (6.73 versus 6.20). Table cacy, our study proved that the community
5 shows the mean scores of eight domains of nurses could be trained to play a key role in
QoL in the two groups. After intervention, in the hypertension management at community level
domain of general health, the mean score and contribute to improvement of patient out-
increased by 9.41 (from 46.53 to 55.94) in the come.
study group (P = 0.017). When compared to the
control group, a significant difference also was The study suffered two major limitations. First,
observed (P = 0.014). These results suggest just like other non-profit intervention studies
that intervention guided by nurse-led hyperten- conducted in the doctor-led health care organ-
sion management model is more effective on isations, it is difficult to conduct a large-scale
enhancing patients general health than the trial. Thus, relatively small sample size in the
control doctor-led management. study might affect evaluation of effects of the
intervention in this study. Second, as with all
Patient satisfaction single-centre study, the generalisability of our
results to other healthcare settings is unknown,
As given in Table 6, the intervention effected no although the centre is a typical community
significant change in this domain in the control health care organization.
group, whereas a significant post-intervention
increase was observed in the study group (t = Patient adherence is associated with clinical
-2.303, p = 0.021). There was also a significant outcomes and health care cost. Improving
difference between the groups after the inter- patient adherence is a vital factor of effective
vention (t = -2.054, p = 0.040). The significant BP control. In this study, trained community
difference was detected within the study group nurses enhanced patient adherence by using
(p = 0.021) as well as between two groups after effective strategies such as home visit and
intervention (p = 0.040). These results suggest telephone follow-ups [27]. The finding that the
that hypertensive patients were more satisfied nurse-led intervention achieved greater patient
with nurse-led hypertension management than adherence than the doctor-led control is con-
the control doctor-led management. sistent with the result of a meta-analyses study
[11].
Discussion
The nurse-led hypertension management mo-
In the doctor-led CHCs, doctors dominate hy- del is practicable in guidance of managing
pertension management. This study has report- hypertensive patients at the community level,
ed the nurse-led hypertension management while its effects on patient BP readings still
model to compare its effects with a traditional need to be evaluated. In further study, efforts
doctor-led model in an experimental trial in should be made to improve structural factors
China. In the study, we have established a such as the health system in order to maximize
nurse-led hypertension management model the effectiveness of the nurse-led model.
guided by 4-C framework [21]. When subjected
to an RCT, our nurse-led model resulted in Acknowledgements
greater patient self-care adherence, satisfac-
tion, and outcomes in some domain of QoL This study was supported by the Central Rese-
than the doctor-led model. Though we could not arch Grant from the Hong Kong Polytechnic
provide sufficient evidence of nurse-led inter- University (RPUY and 8-881Q ) and a Scientific
vention on reducing BP and improving self-effi- Research Grant from Zhejiang Provincial Health
4375 Int J Clin Exp Med 2014;7(11):4369-4377
Nurse-led hypertension management
Department (2010KYA157). Special acknowl- [6] Hackam DG, Quinn RR, Ravani P, Rabi DM,
edgements to Qinqin Hu, Linlin Yu, Liwan Ding, Dasgupta K, Daskalopoulou SS, Khan NA, Her-
and Xueping Wang, who conducted interven- man RJ, Bacon SL, Cloutier L, Dawes M, Rab-
tions in the study. kin SW, Gilbert RE, Ruzicka M, McKay DW,
Campbell TS, Grover S, Honos G, Schiffrin EL,
Bolli P, Wilson TW, Feldman RD, Lindsay P, Hill
Disclosure of conflict of interest
MD, Gelfer M, Burns KD, Vall EM, Prasad
GVR, Lebel M, McLean D, Arnold JMO, Moe
None. GW, Howlett JG, Boulanger J, Larochelle P, Leit-
er LA, Jones C, Ogilvie RI, Woo V, Kaczorowski
Address correspondence to: Dr. Frances Kam Yuet J, Trudeau L, Petrella RJ, Milot A, Stone JA, Dr-
Wong, School of Nursing, The Hong Kong Polytechnic ouin D, Lavoie KL, Lamarre-Cliche M, Godwin
University, Hunghom, Kowloon, Hong Kong Special M, Tremblay G, Hamet P, Fodor G, Carruthers
Administrative Region, P. R. China. Tel: 852-2766- SG, Pylypchuk GB, Burgess E, Lewanczuk R,
6419; Fax: 852-23649663; E-mail: frances.wong@ Dresser GK, Penner SB, Hegele RA, McFarlane
polyu.edu.hk PA, Sharma M, Reid DJ, Tobe SW, Poirier L and
Padwal RS; Canadian Hypertension Education
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