Abstract
We investigated whether self‐blood pressure monitoring (SBPM) can improve the control rate of blood pressure (BP), adherence of antihypertensive medications, and the awareness of the importance of BP control in hypertensive patients. A total of 7751 patients who visited the outpatient clinics of private and university hospitals in Korea were given automatic electronic BP monitors and were recommended to measure their BP daily at home for 3 months. Changes in office BP, attainment of target BP, adherence to taking antihypertensive drugs, and awareness of BP were compared before and after SBPM. Patients and physicians were surveyed on their perception of BP and SBPM. Mean BP significantly decreased from 142/88 to 129/80 mm Hg (P < .001), and attainment of the target BP increased from 32% to 59% (P < .001) after SBPM. Drug non‐adherence, which was defined as patient's not taking medication days per week, decreased significantly from 0.86 days to 0.53 days (P < .001). The rate of awareness of the BP goal increased from 57% to 81% (P < .001). Patients estimated that their mean BP was 125/81 mm Hg, but their actual mean BP was 142/88 mm Hg. Awareness about the importance of SBPM increased from 90% to 98%. The rate of SBPM ≥ once per week further increased, from 34% to 96%. In conclusion, SBPM is associated with reduced BP, better BP control rate, greater drug adherence, and improved perception of BP by the patients.
Keywords: awareness, blood pressure, control, monitoring
1. INTRODUCTION
A large‐scale, cross‐sectional study incorporating data from various countries around the world, including both low‐ and high‐income subjects, showed that the prevalence of hypertension (HTN) was 40.8% in 142 042 participants, but only 46.5% were aware of the diagnosis criteria, and 32.5% had controlled blood pressure (BP), despite the high rate (87.5%) of pharmaceutical treatment.1
Low BP control could be attributed to poor medication adherence and patients' ignorance on the importance of HTN, as well as therapeutic inertia by physicians. To overcome this, many approaches have been attempted including self‐blood pressure monitoring (SBPM). However, this has demonstrated mixed results on HTN control.2, 3, 4, 5 Some meta‐analyses including small‐sized studies have also shown inconsistent results.2, 5 These conflicting data may partly be attributed to the diversity of socio‐economic levels and racial differences of the participants and combined other interventions on top of SBPM as well as small sample size.
We performed this nationwide large‐scale prospective observational study involving general hospitals and local clinics to examine the effectiveness of SBPM in improving BP control, drug adherence, and perception of the importance of BP in both patients and physicians.
2. METHODS
This study was a nationwide single‐arm prospective observational study performed from March 2009 to September 2009 in 150 general hospitals and 204 local clinics in South Korea.
Study objectives included testing the impact of SBPM on BP reduction, target BP attainment, drug adherence, and perception of SBPM and BP in real‐world practice.
Our study was not designed for interventional purposes but simply for observing the efficacy of SBPM. There was also no target number of patients to be recruited.
2.1. Patients
The patients (aged 18‐90 years old) in this study had HTN and regularly visited outpatient clinics for BP control and to receive antihypertensive medications from private or university hospitals in Korea. Patients were recommended by a physician to participate in the study, consenting patients were enrolled after a full explanation of the study, and they provided written informed consent. This study was approved by the institutional review board of Hallym University Sacred Heart Hospital.
Patients were required to have a stable medical status and BP for at least 3 months before enrollment, as determined by the on‐duty doctor (there was no specific cutoff point eg, a 10‐20 mm Hg change in BP, but stable medical status/BP was assessed by the doctor). However, there is a common consensus on the state of being stable, that is, the patient not making any unplanned visits to the clinic for BP control, and no requirement of medication change or dose escalation. Inclusion was determined by the physician and patients who agreed to participate after a full explanation of the study. Those who refused to provide consent were excluded.
Study patients were enrolled consecutively during a 6‐month period. As our study was a prospective observational registry, we did not record the patient number at initial screening or during the study. The final population was recorded after study completion.
2.2. Procedures
A questionnaire regarding the awareness of BP, BP goal, frequency of BP measurement out of the clinic, frequency of drug skipping, and perception of the importance of BP and SBPM was carried out. Each physician and patient was interviewed twice, just before and 3 months after SBPM.
The specific questions for physicians and patients before and after SBPM were as follows, and further information is provided in the supplementary file:
Questions for physicians before SBPM included determining:
Basic demographic patient data such as age, sex, height, weight, and waist circumference.
Mean blood pressure and heart rate from three readings at 2‐minute intervals.
Other concomitant medical history such as diabetes mellitus; heart disease including angina, myocardial infarction, heart failure, atrial fibrillation, cerebrovascular disease, transient ischemic attack; microalbuminuria, gross proteinuria, chronic kidney disease, dialysis, peripheral arterial disease, carotid arterial stenosis, and increase in arterial stiffness.
Detailed medication history such as type of medication, number of drugs, and frequency of administration.
Perception and feelings about SBPM.
Questions for physicians before and 3 months after SBPM:
Frequency of recommending self‐BP measurement.
Perception on the benefits of SBPM.
Perception on the adequate frequency of SBPM.
Perception and feelings on SBPM.
Reasons for patients skipping drugs.
Questions for patients before and 3 months after SBPM:
Knowledge about the BP target and the specific number of target BP.
Frequency of self‐BP measurement at home.
Perception and feelings on SBPM.
Drug adherence.
Reasons for skipping medication.
Office BP was measured for assessing the change of BP and attainment of the BP goal before and after SBPM. As an automated BP monitoring device, OMRON MX3 was used for SBPM at home for each individual. This device was provided to each clinic by AstraZeneca Korea without any commercial purpose, that is, only for supporting patient care. Self‐BP was recommended to be measured twice a day, in the morning, 5‐10 minutes after waking up and just before going to sleep. Frequency of SBPM at home was left up to the individuals during the 3‐month period, even though daily measurements were recommended.
Office BP was checked with an automated or manual BP measuring device at each hospital in a routine manner, just before starting SBPM and 3 months after SBPM. Mean systolic BP (SBP) and diastolic BP (DBP) were determined from three readings, with at least a 2‐minute interval between each reading. The primary outcome was the BP change and attainment of the target BP, 140/90 mm Hg in patients with no complications and 130/80 mm Hg in patients with complications, as determined by the office BP readings after SBPM. Drug adherence, attitude, and knowledge on BP and SBPM were evaluated in both patients and physicians by a survey after the 3‐month period of SBPM. We assessed drug adherence by the self‐reported questionnaire, which was well‐validated and is widely used in clinical practice despite some shortcomings regarding the ease of distortion by the patient and susceptible errors by visit time interval.6 Along with this questionnaire, we also asked patients how many days they usually skipped or lessened their drugs per week.
2.3. Statistical analysis
All data are presented as percentages or as mean ± standard deviation. Statistical analyses of the comparison of BP, target attainment, drug adherence, and awareness of patients before and after SBPM were performed by the paired t test. The McNemar test was used for values in the form of percentages. A comparison of the above parameters between general hospitals (GH) and local clinics (LC) was made by the Student t test or chi‐square test. P values < .05 were considered statistically significant.
3. RESULTS
A total of 7751 patients were recruited consecutively, 3827 from GH and 3924 from LC; 354 physicians, 150 from GH and 204 from LC participated in the study. Patients' baseline characteristics are shown in Table 1.
Table 1.
Baseline patients characteristics
| Characteristic (n = 7751) | n (%) |
|---|---|
| Age, y | 58.7 ± 11.0 |
| Men | 3953 (51) |
| Hypertension | 7751 (100) |
| Diabetes mellitus | 3100 (40) |
| Dyslipidemia | 3023 (39) |
| Angina pectoris | 1705 (22) |
| Myocardial infarction | 698 (9) |
| Stroke | 388 (5) |
| Metabolic syndrome | 465 (6) |
| Renal disease | 310 (8) |
3.1. Reduction of BP and attaining target BP after SBPM
The office BP reading significantly decreased from 142/88 to 129/80 mm Hg (P < .001) after the 3‐month program of SBPM (Figure 1). Results were similar in patients from the GH and LC, from 142/86 to 130/79 mm Hg and from 141/89 to 127/82 mm Hg, respectively (Figure 1).
Figure 1.
Reduction of BP after the 3‐mo program of SBPM
The overall control rate of BP defined as ≤140/90 mm Hg in patients without complications and ≤130/80 mm Hg in patients with complications, significantly improved from 32% to 59% (P < .001). The control rate of BP significantly improved from 47% to 78% in patients without complications (P < .001) and 22% to 47% (P < .001) in patients with complications (Figure 2). The overall BP control rate increased from 29% to 53% (P < .001) in the GH and from 36% to 65% in the LC (P < .001).
Figure 2.
Attainment of target BP of both SBP <140 mm Hg and DBP <90 mm Hg for patients with no complications and SBP <130 mm Hg and DBP <80 for patients with complications before and after the 3‐mo SBPM
3.2. Change in drug adherence after SBPM
Drug non‐adherence, defined as the number of days per week in which medication was skipped or lessened, decreased significantly after SBPM from an average of 0.86 days to 0.53 days per week (P < .001; Figure 3). Drug adherence improved as the SBPM rate increased (Figure S1). The main reasons for skipping or lessening antihypertensive medication prior to SBPM were “I forgot to take the drug” and “I do not like taking medication,” with a proportion of 79% and 9%, respectively. These decreased to 72% and 4%, respectively, after SBPM. Conversely, the reply of “I am in a better condition than before” increased from 7% to 16% (Figure S2).
Figure 3.
Changes in drug compliance before and after SBPM. Vertical axis indicates the rate of lessening (upper red part in bar) or skipping (lower blue part in bar) drug number/week. Number in each box indicates the rate of drug lessening or skipping rate, number/week
3.3. Physician's perception on SBPM before the study
Of the 354 physicians, 92% agreed with the notion that SBPM is important (59% important and 33% very important). The percentage of physicians who willingly encouraged their patients to monitor their own BP at home was 91%. There were no differences between GH and LC doctors regarding the encouragement of SBPM (93% vs 90%) or recognition of the importance of SBPM (93% vs 91%). One‐third of the physicians (67%) considered that SBPM would increase the control rate of HTN, 63% in GH and 70% from LC with no significant difference.
Although physicians would like to recommend SBPM to patients, they anticipated the actual rate of patients who would monitor BP at home by themselves as 23.7%, GH physicians 26.5%, and LC doctors as 21.6%.
3.4. Patients' perception on BP, target BP, actual office BP, and drug adherence before SBPM
Most patients (90%) recognized the importance of SBPM; 50% replied that SBPM is very important, 40% considered SBPM to be important, and 9% were neutral. These percentages did not differ according to gender or age.
The generally accepted BP goal known as <140/90 mm Hg was not considered in this study. We investigated the target BP value as that the patients perceived in the real world; 57% of patients replied that they knew the BP target as the range from 120/80 mm Hg to 140/90 mm Hg. The mean BP estimated by patients was 125/81 mm Hg, but their actual mean BP was 142/88 mm Hg, as shown by office BP measurements before SBPM.
There were 20% of patients who measured SBPM at least once per week prior to the study, and the frequency of SBPM was higher in patients from LC than GH, 23% vs 18%, respectively. Although GH physicians expected a higher rate of SBPM by their recommendation among their patients (26.5%) than patients from LC (21.6%), the actual situation was reversed, that is, higher in patients from LC.
Patients who knew their BP goal (n = 4391) monitored their BP more often than patients who did not (n = 3360), 43% vs 24%, respectively (aware of BP goal vs not aware of BP goal; P < .001).
3.5. Changes in patients' awareness on BP goal after the 3‐month SBPM
The proportion of patients who were aware of BP goal (as their own perceived BP goal) increased from 57% to 81% (P < .001) among all responders. The value of 120/80 mm Hg was assumed to be the normal target BP by most patients. The proportion of patients who were aware of target BP as 120/80 mm Hg increased from 33% to 46% (by 13%), from 55% to 75% in GH (by 20%), and from 59% to 88% in LC (by 29%) at the second visit after the 3‐month SBPM.
When we considered the target BP as 140/90 mm Hg or below, the rate of awareness increased from 84% to 88% after SBPM. Patients considered the BP goal at the second visit to be 124/81 mm Hg. In addition, the rate of SBPM ≥ once per week increased further, from 34% to 96%, with similar patterns in both GH and LC.
4. DISCUSSION
The main findings of our study are that SBPM for 3 months is associated with improved patient awareness, drug adherence, and BP control rate from a nationwide large cohort including 7751 hypertensive patients. Office BP reduced significantly from 142/88 to 129/80 mm Hg, and BP control rate increased significantly from 32% to 59%. Patients' and physicians' perception on BP, HTN, and BP medications were positively adjusted.
Hypertension is a prevalent disease and is rapidly increasing mainly due to the growing elderly population.6 However, the control rate of HTN is static, even with a myriad of evidence to show the benefits of BP control.1, 7 Recent epidemiologic results have indicated that the control rate of HTN is only around 50%.1, 8 This sustained poor control could be attributed to inadequate prescription of medications, therapeutic inertia of doctors,9 increment of resistant HTN, and a growing population with comorbidities that requires other drugs like nonsteroidal anti‐inflammatory drugs.10, 11
However, the first and most important reason is, we consider, poor adherence to drugs.10 This is supported by the data that antihypertension drug adherence is only 20%‐80% worldwide and 61% in Korea.12, 13 To overcome this poor adherence rate, some measures are being developed, like devices for drug intake alarms, drug reminder applications in smartphones, and traditional drug holder cases.14, 15, 16 However, these are indirect forms of aiding drug intake external to the patients, that is, controlling the person by artificial tools, but not by the person's inner motivation. By contrast, the SBPM method stands out because it is self‐initiated direct performance by the patient and can be regarded as a kind of bio‐feedback system. Our study is similar to a previous one that showed promising results of BP monitoring and controlling by hand lettering regarding BP of patients in view of the same feedback system methods.17
Previous studies that tested the effectiveness of SBPM are small‐sized and heterogeneous.18, 19, 20, 21 Moreover, SBPM in those studies were mostly combined with other interventions like counseling, self‐drug titration, or educations.18, 19, 20, 21 Therefore, studies to test the effectiveness of SBPM itself are scarce.
A randomized study including 441 patients with uncontrolled BP that assessed SBPM effectiveness revealed a significant reduction of systolic BP by 4.3 mm Hg after 6 months. Interestingly, the SBPM group did not show any differences in drug adherence, but did have better weight lost.21 A meta‐analysis by Fletcher and colleagues showed improved office DBP reduction by SBPM, irrespective of improvement in adherence. That is, the drug non‐adherent group also had BP reduction.22 Notably, they addressed that nine studies included in their meta‐analysis had available data on diet and physical activity, and SBPM had a favorable effect on those.22 Therefore, we can consider there could be other factors influencing BP reduction with SBPM other than drug adherence.
Although we did not directly investigate behavioral changes and could not present the data, we can assume that SBPM could affect the patient on the perception on BP control and lead the person to pay more attention to lifestyle changes such as activity, dietary habit changes, and drug intake.
Another meta‐analysis also showed supporting evidence of BP reduction by 3.9/2.4 mm Hg at 6 months after SBPM, and SBPM plus additional interventions indicated a greater decrease in BP up to −8.9/−4.4 mm Hg after 12 months.23 Likewise, recent meta‐analysis including 8292 patients from 36 randomized trials demonstrated similar evidence of the association of SBPM with a 3.2 mm Hg reduction of clinical BP at 12 months.5 It is noteworthy, as the authors emphasized, that the BP reduction was strongly influenced by co‐interventions such as medication titration and lifestyle education by healthcare providers. The office SBP/DBP reduction was greater in the SBPM plus counseling/telecounseling group compared with that in the SBPM alone group, −6.10/−2.32 mm Hg vs −1.02/−1.1 mm Hg of SBP/DBP, respectively.
The major difference of our study compared with the studies indicated above is the provision (or lack thereof) of combined care. Although we provided no other interventions apart from SBPM, our study demonstrated a significant reduction in office BP (−13/−8 mm Hg), comparable to that of the combined intervention group in the aforementioned meta‐analysis. This could be a strength of our study, but may reflect an inevitable bias linked to undeclared counseling or hidden confounders of our study.
We think that the short 3‐month period of SBPM can be one explanation of the BP reduction in our study. As short‐term SBPM was more easily performed, we could sustain participant's adherence and concentration on SBPM more efficiently, which led to a more pronounced BP reduction compared with the 6‐ to 12‐month SBPM of the above studies.
In our study, we were able to demonstrate improved knowledge of BP among patients and physicians as well as better drug adherence. We can therefore postulate that better attention to BP and improved drug adherence could contribute to the reduced office BP.
In our study, 40% of patients were diabetic; therefore, investigating changes in glucose in this subgroup after SBPM could have helped to indirectly estimate the impact of lifestyle changes on BP, as changes in glucose can reflect the lifestyle modifications.
Our study is just a single‐arm observational investigation and cannot avoid biases; thus, we cannot conclude that SBPM solely accounts for BP reduction. Despite these drawbacks, our study has strengths.
This study is the first large‐scale prospective nationwide investigation that has enrolled 7751 hypertensive patients, comparable to the size of previous meta‐analyses.
The data regarding perception and attitude to BP and SBPM of patients and physicians are other strengths of our study, which are unique and have rarely been reported in other studies with this large‐scale population. These data are important as it can provide an insight into the mechanism of increased drug adherence, which is our main possible explanation for improved BP control rate, although we acknowledge that lifestyle changes such as salt reduction, engaging in more exercise, and losing weight during the SBPM period could influence BP.
Our study has some limitations.
Firstly, this study is not a randomized controlled trial that compared an SBPM with a control group, but instead, it is an observational single‐arm trial. There could have been inevitable biases despite the large scale. The reduction in BP could have been driven by other confounding factors such as medications, diet habits or counseling, exercise, visits to doctors' office per se, accustomed to circumstance of the office BP measurement, and participating in this HTN clinical study itself.
SBP reduction by 10‐12 mm Hg is often observed in the control groups of BP trials. Therefore, the observed reduction of 13 mm Hg SBP in our study could have been influenced by medication intensification or changes or may have been drawn by chance‐like regression to the mean. There could be a selection bias for both patients and physicians in this study. Patients who appeared more likely to be interested in BP control and more willing to be devoted to this study could have been enrolled in the study, and these patients would therefore be more engaged and would achieve a better BP reduction. Physicians who were interested in the patients' BP and the BP study itself may have been more likely to enter this study. We do not have any comparison; thus, it is difficult to know how much these selection biases explain the results, particularly those of the surveys and some of the process outcomes such as SBPM rate per week. Therefore, our results have limitations to be generalized and ought to be interpreted cautiously.
Secondly, we did not examine the patients' true measurement of BP at home or the frequency of BP, but only depended on the patients' replies to the questionnaires. More importantly, we did not validate the questionnaires, which is very critical in accurate collection of adherence data.
Thirdly, we estimated drug adherence using the survey, not by exact counting of the remaining drug, which is known as the gold standard.24 There could be a recall bias or intended untruthful replies, which are inevitable limitations of the survey.
Fourthly, we did not ask patients about any lifestyle changes that may have influenced the patients' BP. As mentioned earlier, this may have influenced BP and drug adherence.
Fifthly, our study was only performed for 3 months; thus, the long‐term benefits of SBPM cannot be determined. Conducting SBPM for a longer time is vital, and this is also a future challenge for research subjects.
In addition, we did not collect any data regarding the type, dose of antihypertensive medications or drug intensification, which may have been different before and after SBPM, and this could have altered BP control and drug adherence. However, in the short period of 3 months, an increment of dose was unlikely to have occurred.
Finally, 20% of patients of the study participants were already using SBPM prior to the investigation. These patients could have been more willing to take part in the study and follow the doctors' indications, which could have biased the results.
Despite these limitations, our large prospective observational study has shown an association of SBPM with an improvement in BP control, with supporting data such as improved drug adherence and perception on BP, which has provided added value compared with previous studies.
A larger prospective randomized trial that aims to significantly improve clinical outcomes with SBPM is warranted to demonstrate the true efficacy of SBPM and for widespread adoption of this method to increase drug adherence and BP control rate.
5. CONCLUSIONS
In this large population study, SBPM was shown to be associated with an improvement of patients' awareness of BP, drug adherence, reduction of BP, and better BP control in hypertensive patients receiving antihypertensive medications.
CONFLICT OF INTEREST
None declared.
AUTHOR CONTRIBUTIONS
SHJ conceptualized and designed the study, acquired funding, analyzed the data, supervised the study, and revised the manuscript. SAK revised the manuscript. KHP, HSK, SJH, and WJP participated in patient enrollment and data collection. All authors read and approved the manuscript.
Supporting information
ACKNOWLEDGEMENTS
We are very grateful for the support from AstraZeneca Korea.
Jo S‐H, Kim S‐A, Park K‐H, Kim H‐S, Han S‐J, Park W‐J. Self‐blood pressure monitoring is associated with improved awareness, adherence, and attainment of target blood pressure goals: Prospective observational study of 7751 patients. J Clin Hypertens. 2019;21:1298–1304. 10.1111/jch.13647
Funding information
This work was supported by ITECH R&D program of MOTIE/KEIT. [project No. 10053597, Development of High‐Speed Signal Processing IC and Platform for Contactless Monitoring of Bio‐Signal in Vehicle].
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