MJMHS 0513
MJMHS 0513
MJMHS 0513
ORIGINAL ARTICLE
ABSTRACT
Introduction: Hypertension treatment aims to reduce morbidity and mortality from cardiovascular and renal com-
plications. In Malaysia, there is a high prevalence of uncontrolled hypertension among patients on treatment. This
study aimed to identify the predictors of uncontrolled hypertension among patients receiving treatment from public
primary care clinics in Pulau Pinang, Malaysia. Methods: An unmatched case-control study with 1:1 ratio was con-
ducted among 334 hypertensive patients receiving treatment from selected public primary care clinics. Mean blood
pressure measurements from the last two clinical visits were used to determine the hypertension status, and uncon-
trolled hypertension was defined as 140/90 mm Hg or higher. The cases were those with uncontrolled hypertension,
while the controls were those with controlled hypertension. Participants were recruited by simple random sampling.
Independent variables were sociodemographic factors, clinical and psychosocial factors, medication adherence,
lifestyle modification, and clinical inertia. Data were collected using validated questionnaires and review of medi-
cal records. Multiple logistic regression analysis was performed by using IBM SPSS Statistics 25. Results: The mean
age of respondents was 59 years (SD=11). Patients with medication non-adherence had 11.36 times higher odds of
uncontrolled hypertension (aOR=11.36, 95% CI=6.59, 19.56, p<0.001). Clinical inertia increased 7.82 times the
odds of uncontrolled hypertension (aOR=7.82, 95% CI=2.65, 23.09, p<0.001). Conclusion: Addressing medication
adherence and clinical inertia are vital in reducing uncontrolled hypertension. The findings would help to prioritise
interventions to improve the clinical management of hypertension and patient outcomes.
few studies ranging from 26.6% to 31% (8–10). complex medication regimens (22).
Literature suggests that multiple factors are The sampling frame was obtained from the list of
associated with hypertension control. With regards to hypertensive patients from the clinic appointment
sociodemographic factors, the associations between system. The mean documented blood pressure readings
age, gender, ethnicity and hypertension control from from the last two clinic visits was used to determine
previous studies are inconsistent (2,9–12). Higher the hypertension status. Cases were defined as patients
educational level is associated with better hypertension with uncontrolled hypertension (≥140/90 mm Hg) and
control (9,10). As for clinical factors, an increased controls were patients with controlled hypertension
number of anti-hypertensive agents is associated with (<140/90 mm Hg). The Schlesselman case control study
uncontrolled hypertension (13,14). Stress has been formula was used to calculate the sample size (23) and
associated with medication non-adherence (15), the proportion values were obtained from the local
although little is known about the association between study on hypertension control (21). A minimum sample
stress, depression, anxiety and hypertension control. size of 163 per group was required, assuming a type-1
A number of studies reported a significant association error of 5% (α = 0.05) and a power of 80%. Given a 20%
between medication adherence and hypertension possible non-response rate, the final sample size was
control (16–18). In terms of lifestyle modification, 205 per group. As 1:1 ratio was used for the number of
high dietary salt intake is associated with uncontrolled cases and controls, a total of 410 patients were selected
hypertension (19). However, the association between from the appointment list by simple random sampling
smoking and hypertension control is inconsistent method using the random number generator in Excel.
(10,12,14), with scarce data on the association between
physical activity, alcohol consumption and hypertension Instruments
control. Despite the existence of guidelines on the Two study instruments were used, a proforma to
management of hypertension, the clinical inertia or extract data from the patient's medical record and a
lack of active management, is known to be associated questionnaire. The proforma included age, gender,
with uncontrolled hypertension (20). A few studies ethnicity, blood pressure readings, body mass index,
found that adherence to the guideline and appropriate number and frequency of anti-hypertensive agents used,
intensification of treatment were associated with and clinical inertia assessment. Clinical inertia was
controlled hypertension (11,21). present when no active management was performed
as recommended in the Malaysian Clinical Practice
Most of the previous studies on hypertension control in Guideline on Hypertension (24) when the patient had
Malaysia were cross-sectional studies, in which the study uncontrolled blood pressure during any follow-up visits
design was mainly used to determine the prevalence. In in the past one year without a documented reason or
this paper we describe the use of a case-control study refusal by the patient. Active management included
to identify the predictors of uncontrolled hypertension increasing the dose of the anti-hypertensive agent;
among hypertensive patients receiving treatment replacing the initial anti-hypertensive agent with another
from public primary care clinics in a district of Pulau class; adding another anti-hypertensive agent; assessing
Pinang, Malaysia. The findings would help to prioritise patient adherence to the medication; or advising on
interventions to improve the clinical management of lifestyle modification.
hypertension and patient outcomes.
The questionnaire consisted of seven sections. The
MATERIALS AND METHODS first section was on additional sociodemographic and
clinical data, including education level, living status,
Study design, setting and sample selection and hypertension duration. The second section was
A clinic-based unmatched case-control study was medication adherence assessment. As the Malay
conducted in all five public primary care clinics in the version of the Hill-Bone Compliance to High Blood
Seberang Perai Tengah District, Pulau Pinang, Malaysia Pressure Therapy Scale developed and tested for use in
from November 2018 to April 2019. The study population Malaysian primary healthcare settings did not conform
was hypertensive patients aged 18 to 80 years old who to the structural, predictive validity and reliability of the
received at least one year of treatment from any of the original scale, thereby limiting its use in current study
clinics. The study excluded patients who had defaulted (25). With reference to the study findings, the medication
appointments during the study period or their last adherence scale used in the current study removed
visit to clinic more than six months from the sampling items with poor correlation with remaining items and
date, and those with diabetes mellitus, ischaemic heart added two important items from other scales to reflect
disease, cerebrovascular disease or renal impairment. the non-adherence concept in Malaysia (16,26). The
Hypertensive patients with other major diseases were current eight items questionnaire used a four-point
excluded because they had different blood pressure scale to indicate the frequency of medication taking
targets. In addition, they may not able to recognise the behaviour over the past six months, 1=never, 2=rarely
exact effect of anti-hypertensive medication due to their (once monthly or less), 3=sometimes (two to three times
patients agreed to participate, making the response Table II: Clinical factors, psychosocial factors, medication adherence
rate 81.5%. The main reason for non-response was the and lifestyle modification of participants
refusal to participate due to time constraints, as either Cases Controls
Variables (n=167) (n=167) χ2 test (df) p value
they or their caregivers had to go to work after the n (%) n (%)
follow-up visits. Participants age ranged from 21 to 79 Duration of hypertension (years) 0.221 (2) 0.896
years (mean=59.4, SD=11.4). Both groups had a higher <5 75 (44.9) 73 (43.7)
percentage of females, Malay ethnicity, secondary
5-10 59 (35.3) 63 (37.7)
education, and stayed with the family (Table I). Among
>10 33 (19.8) 31 (18.6)
the cases, 55.1% had hypertension for more than 5 years,
Number of AHA types used
1
4.841 (1) 0.028*
61.1% had two or more anti-hypertensive agents and
93.4% had once daily medication regimens (Table II). One 65 (38.9) 85 (50.9)
While 56.7% of the controls had hypertension for more Two or more 102 (61.1) 82 (49.1)
than 5 years, 49.1% had two or more anti-hypertensive Daily dose frequency of AHA 1
1.007 (1) 0.316
agents and 90.4% had once daily medication regimens. Once 156 (93.4) 151 (90.4)
Twice or more 11 (6.6) 16 (9.6)
Table I: Sociodemographic characteristics of participants
Body Mass Index 3.748 (2) 0.154
Cases (n=167) Controls
Variables n (%) (n=167) χ test (df)
2
p value Normal 30 (18.0) 37 (22.2)
n (%)
Overweight 66 (39.5) 76 (45.5)
Age (years) 59.8 (11.2)1 59.0 (11.5)1 0.682 0.496
Obese 71 (42.5) 54 (32.3)
(332)2
Depression 0.320 (1) 0.572
Gender 0.199 (1) 0.655
Abnormal score 14 (8.4) 17 (10.2)
Male 65 (38.9) 69 (41.3)
Normal score 153 (91.6) 150 (89.8)
Female 102 (61.1) 98 (58.7)
Anxiety 3.662 (1) 0.056
Ethnicity 1.469 (2) 0.480
Abnormal score 20 (12.0) 10 (6.0)
Malay 91 (54.5) 85 (50.9)
Normal score 147 (88.0) 157 (94.0)
Chinese 60 (35.9) 59 (35.3)
Stress 0.420 (1) 0.517
Indian 16 (9.6) 23 (13.8)
Abnormal score 10 (6.0) 13 (7.8)
Educational Level 0.866 (4) 0.929
Normal score 157 (94) 154 (92.2)
No formal 6 (3.6) 7 (4.2)
education Dietary salt intake 2.724 (2) 0.256
Primary 52 (31.1) 47 (28.1) Low 52 (31.1) 61 (36.5)
Secondary 84 (50.3) 91 (54.5) Moderate 72 (43.1) 75 (44.9)
Pre-university 10 (6.0) 8 (4.8) High 43 (25.7) 31 (18.6)
Tertiary 15 (9.0) 14 (8.4) Physical activity level 0.487 (2) 0.784
Living status 0.363 (1) 0.547 Low 71 (42.5) 77 (46.1)
Staying with 152 (91.0) 155 (92.8) Moderate 81(48.5) 77 (46.1)
family
High 15 (9.0) 13(7.8)
Staying alone or 15 (9.0) 12 (7.2)
in care insti- Smoking status 2.173 (2) 0.337
tution Current smoker 20 (12.0) 22 (13.2)
1
mean (SD) 2
t(df)
Former smoker 15 (9.0) 23 (13.8)
The prevalence of overweight and obesity among Never smoker 132 (79.0) 122 (73.0)
participants was high with 82% of cases and 77.8% of Alcohol Consumption 1.099 (1) 0.295
controls (Table II). The percentage of DASS abnormal Current drinker 30 (18.0) 23 (13.8)
scores for depression, anxiety and stress ranged from
Non-drinker 137 (82.0) 144 (86.2)
6.0% to 12.0% for cases, and 6.0% to 10.2% for
Medication adherence 94.536 (1) <0.001*
controls. High dietary salt intake was reported in 25.7%
Adherence 28 (16.8) 116 (69.5)
of cases and 18.6% of controls. The prevalence of low
level of physical activity was high with 42.5% of cases Non-adherence 139 (83.2) 51 (30.5)
and 46.1% of controls. There were 12.0% of cases and Number of follow- 4.2 (1.2)2 3.8 (1.1)2
up visits per year
13.2% of controls were current smokers, while 18.0%
Clinical inertia 22.157 (1) <0.001*
of cases and 13.8% of controls consumed alcohol. It
was found that 83.2% of cases were non-adherent to Presence 32 (19.2) 5 (3.0)
medication as compared to 30.5% of controls. The Absence 135 (80.8) 162 (97.0)
*p < 0.05 level (2-tailed)
mean number of follow-up visits per year for cases was 1
AHA: Anti-hypertensive agents
4.2 (SD=1.2) and 3.8 (SD=1.1) for controls. Clinical 2
mean (SD)
results, including sociodemographic factors, duration of Two or more 0.49 1.63 (1.05, 2.51) 4.82 0.028*
hypertension, body mass index, daily dose frequency Daily dose frequency of AHA 1
of medication, psychosocial factors, and lifestyle Once 0.41 1.50 (0.68, 3.34) 1.00 0.318
modification (Table III & IV). Twice or more 0 1
Table III: Association of uncontrolled hypertension with sociodemo- Body Mass Index
graphic factors by simple logistic regression analysis
Normal 0 1
Regression Crude odd
Wald Overweight 0.07 0.82 (0.60, 1.92) 0.05 0.818
Variables coefficient ratio p value
statistic
(b) (95% CI) Obese 0.48 0.11 (0.89, 2.95) 2.51 0.113
Age (years) 0.01 1.01 0.47 0.494 Depression
(0.99, 1.03)
Abnormal score -0.21 0.81 (0.38, 1.70) 0.32 0.572
Gender
Normal score 0 1
Male 0 1
Anxiety
Female 0.10 1.11 0.20 0.655
(0.71, 1.71) Abnormal score 0.76 2.14 (0.97, 4.72) 3.53 0.060
Living status Current smoker -0.17 0.84 (0.43, 1.62) 0.27 0.602
With family 0 1 Former smoker -0.51 0.60 (0.30, 1.21) 2.04 0.154
with p value < 0.25 were included for multiple logistic Medication adherence
regression (33). Eight variables were selected, including Adherence 0 1
ethnicity, body mass index, anxiety, number of anti- Non-adherence 2.42 11.29 (6.69, 82.60 <0.001**
hypertensive agent types used, medication adherence, 19.05)
dietary salt intake, smoking status, and clinical inertia. Clinical inertia
The forward selection with likelihood ratio method Presence 2.04 7.68 (2.91, 20.26) 16.98 <0.001**
appeared to be the most fit model. There was no Absence 0 1
multicollinearity, with a small correlation between the *p < 0.05 level (2-tailed), ** p <0.001 level (2-tailed)
1
AHA: Anti-hypertensive agents
variables (r =0.13) and a variance inflation factor of less Medication non-adherence is a predictor of uncontrolled
than 10. No significant interaction effect was noted in hypertension consistent with the results of previous
the model (p=0.585). studies (16–18). Medication non-adherence is the
main reason why treatment that has been shown to be
Only two variables, namely medication adherence efficacious in randomised clinical trials is often less
and clinical inertia, were found to be significant in the effective in real clinical practice (34). It has been widely
final model. Hypertensive patients with medication described as either intentional or unintentional because
non-adherence had 11.36 times the odds of having of the different factors associated with each and the need
uncontrolled hypertension (aOR=11.36, 95% CI=6.59, for different tailored solutions (25,34–36). Intentional
19.56, p<0.001) when adjusted for clinical inertia. It non-adherence refers to a process in which the patient
also showed that hypertensive patients experienced consciously decides not to use the medication or not
clinical inertia had 7.82 times the odds of having to follow the prescribed regimen. Unintentional non-
uncontrolled hypertension (aOR=7.82, 95% CI=2.65, adherence, on the other hand, is an unplanned passive
23.09, p<0.001) when adjusted for medication non- process and involves factors beyond the control of the
adherence (Table V). The model explained 40% of the patient (34,35). The medication adherence scale used in
variance in uncontrolled hypertension (Nagelkerke R current study is able to assess these two components of
square= 0.40) and was able to correctly classify 76.6% non-adherence behaviour.
(95% CI=71.73, 81.08) of the subjects. The Hosmer-
Lemeshow Goodness-of-Fit Test showed a good fit of There are four items that imply unintentional non-
the model (p=0.859). adherence, including forgetfulness, skipped as running
out of medication, skipped as forgotten to bring along
Table V: Predictors of uncontrolled hypertension by multiple logistic
regression model when away from home, and skipped before going to
Adjusted Wald
see their physician. Forgetfulness was the most common
Regression Standard
Variables coefficient error
odd ratio statistic
p value
reason of non-adherence among participants in current
(95% study, which could be due to difficulties in making it a
(b) (SE)
CI) a
habit, as reported in a systematic review of qualitative
Medication adherence
and quantitative studies on barriers to hypertension
Adherence 0 1 <0.001**
therapy (37). Intervention to improve medication self-
Non-adher- 2.43 0.28 11.36 76.66 management skills is needed to help patients remember
ence (6.59,
19.56) to take medication by integrating it into their daily routine
Clinical inertia (35). Patients may benefit from the use of pill boxes to
Presence 2.06 0.55 7.82 13.87 <0.001**
organise their medication by day of the week and timing
(2.65, for each pill, or using calendars or telephone reminders
23.09) to help them remember to take their medication at the
Absence 0 1 right time (38). Healthcare providers may also help to
Constant -1.61 remind patients of timely medication refills by sending
** p <0.001 level (2-tailed)
a
Forward likelihood ratio multiple regression model was applied
text messages to their mobile phones (34).
groups by using a case-control approach to maximise clinical practice, including addressing the barriers that
the power to detect a significant difference. The case- patients may encounter in their efforts to maintain blood
control approach has also made it possible to identify pressure and optimal health.
the predictors of uncontrolled hypertension with its
relative importance by calculating the odds ratio, which CONCLUSION
could help to prioritise the specific management plan
and the counselling content of each follow-up visit for The study findings suggest that priority should be given
better patient outcomes. to improving medication adherence and reducing
clinical inertia in the management of uncontrolled
The interviewer-assisted method used to collect hypertension. A routine assessment of medication
data from participants improved the response rate adherence is recommended during follow-up visits by
and data quality. The possibility of missing data and using a short and validated questionnaire. In addition,
misinterpretation of the questions being asked has the evaluation of clinical inertia should be included
been minimised. However, this method may be subject in the hypertension quality assurance programme
to socially desirable response bias, particularly in the in public primary care clinics. Despite the lack of a
assessment of medication adherence. In order to reduce significant relationship between lifestyle modification
the bias, the interviewer asked questions in a non- and uncontrolled hypertension, the clinical significance
judgmental manner and normalised non-adherence by of lifestyle modification cannot be denied. In fact, these
recognising the difficulties of adhering to medication. statistically insignificant results indicated that most
hypertensive patients, regardless of their hypertension
The use of the questionnaire is limited by recall bias. The status, were reluctant to make major lifestyle changes.
medication adherence scale has the longest recall period Therefore, more effort is needed to encourage lifestyle
of six months, although this has been done with the aim modification, in view of the enormous health benefits
of optimising response options. Since the hypertension that it could offer in addition to hypertension control.
control in this study was determined by mean blood
pressure readings during the last two visits, an average ACKNOWLEDGEMENTS
of three to four months apart, a longer recall period
was required to establish a meaningful association. In The authors would like to thank the Director General of
addition, the different time frames for recall periods Health Malaysia for his permission to publish this paper.
used in the respective sections of the questionnaire may The authors are very grateful to all participants in the
appear unclear to participants and therefore require study for giving their time and information. A special
further emphasis and clarification from the interviewer. thanks to all health care providers at study sites for their
Due to this limitation, it is recommended that the support during data collection.
questionnaire in this study to be used as an interviewer-
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