ORIGINAL
PAPER
Home BP Monitoring Using a Telemonitoring System is Effective for Controlling BP in a Remote Island in Japan Toshiki Kaihara, MD;1 Kazuo Eguchi, MD, PhD;2 Kazuomi Kario, MD, PhD2 From the Niijima-mura National Health Insurance Clinic, Tokyo;1 and Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan2
The purpose of this study was to assess whether a home blood pressure (HBP) telemonitoring system could improve BP control and overcome the problems of HBP monitoring in a remote location. The authors enrolled 60 subjects and randomized them to either a Telemonitoring group or a Control group. The outcomes were changes in HBP level, adherence to HBP monitoring, and visual analog scale (VAS; score 0–100) as a measure of the motivation to perform HBP measurements. The reductions in morning systolic BP ( 5.50.9 mm Hg vs 0.70.7 mm Hg, P140 mg/dL); (2) dyslipidemia (total cholesterol >240 mg/dL or the use of lipid-lowering drugs); (3) hypertension (while taking medication or office SBP >140 mm Hg or office DBP >90 mm Hg); (4) current smoking (within 1 year); (5) kidney disease (albuminuria or creatinine >1.1 mg/dL); (6) atrial fibrillation; (7) metabolic syndrome; (8) chronic obstructive pulmonary disease; and (9) sleep apnea syndrome. We measured subjects’ office BP consecutively three times at about 15second intervals16 with the patients in the sitting position after resting for 1 to 2 minutes on at least two different occasions following the guidelines of the Japanese Society of Hypertension.17 The exclusion criteria were as follows: (1) current residence anywhere other than Niijima (or living off Niijima more than half of the year); (2) ischemic heart
disease; (3) stroke (except asymptomatic and transient); (4) aortic dissection; (5) peripheral artery disease; (6) heart failure requiring hospitalization within the past 6 months; (7) hemodialysis; (8) inability to provide informed consent, self-measure BP, or walk; and (9) presence of serious diseases other than those described in the inclusion criteria. We recorded employment status, sleeping time, waistto-hip ratio, upper arm diameter, medication status, family history of hypertension or other illness, current smoking, habitual drinking, past medical history, state trait anxiety inventory (STAI), and Beck depression inventory (BDI) for each subjects. Employment status was defined as working and receiving a salary. Habitual drinking was defined as drinking any alcohol every day or almost every day. Data on family history of hypertension, current smoking, alcohol intake, employment, and sleeping time were based mainly on self-reported information. The ethics committees of the internal review board at Jichi Medical University School of Medicine, Tochigi, Japan, approved the protocol (clinical category #13-02). All subjects were ambulatory and all gave written informed consent to participate in the study. Measurements In this study, subjects used automated oscillometric HBP monitors. They used conventional BP monitors (HEM7080IC; Omron Healthcare Co, Kyoto, Japan) or BP monitors with a telemonitoring system that stored and transmitted data to a secure Web site (HEM-7251G, Omron Healthcare Co). The HEM-7080IC device has an algorithm equivalent to that in the HEM-705IT, which was validated in an international protocol.18 The HEM7251G is also a validated automated oscillometric device.19 When using the HEM-7080IC, subjects manually recorded their HBP data at the same time that their HBP data were input into their device, which we were able to confirm. On the other hand, the HEM-7251G received acquired physiological data (BP, pulse rate [PR]) wirelessly and transmitted them to the central Web server via the Internet. We were thus able to check the data of subjects using the HEM-7251G in real time. Subjects measured their HBP consecutively three times at about 15-second intervals in the morning and evening. The 15-second interval was validated in a previous study,16 and the same interval was used in our recent publication of the Japan Morning Surge—Home Blood Pressure (J-HOP) study.20 In the morning they measured HBP within 1 hour after rising (after urination and breakfast and before taking medicine), and in the evening they measured their HBP in the sitting position before sleeping and after resting for 1 to 2 minutes following the guidelines of the Japanese Society of Hypertension.17 The baseline HBP data used in the analyses were the first measurement only, but subsequent HBP data were the average of three times. Office BP was measured by conventional BP monitors (HEM-7080IC, Omron Healthcare Co) consecutively The Journal of Clinical Hypertension
Vol 16 | No 11 | November 2014
815
Home BP Telemonitoring in Japan | Kaihara et al.
three times at about 15-second intervals on the first day, 14th day, and 28th day following the guidelines of the Japanese Society of Hypertension. The baseline office BP data used in the analyses were also only the first-time measurement. Subjects collected urine samples in the morning on the first day and on the 28th day. The urine samples were frozen immediately after collection, and periodically transported to SRL Inc (Tokyo, Japan), where urinary microalbumin was measured. The urinary albumin per creatinine ratio (UACR) was calculated by the same laboratory. Arterial stiffness was assessed by brachial-ankle pulse wave velocity (baPWV). The baPWV was measured using a volume-plethysmographic device with four cuffs fitted with oscillometric sensors (form BP-203RPE II; Omron Colin Co, Ltd, Tokyo, Japan) at the same time as the UACR measurements. Study Design This study was a prospective, randomized, open, and comparative investigation of two different methods of HBP measurement. After confirming eligibility and obtaining informed consent, subjects were assigned to either a Telemonitoring group or a Control group. The subjects were randomized by a random number table in the research office of Jichi Medical University. An assigned doctor was given the allocation results by telephone or e-mail at enrollment. During the study period, we did not change any antihypertensive medications. All subjects received and used the conventional HBP monitor (HEM-7080IC) first and were instructed to measure their HBP as many days as possible. They brought the HBP monitor to the clinic 2 weeks later. After getting the allocation results, the Control group continued the HBP measurements using the same HBP monitor for two more weeks. The Telemonitoring group changed HBP monitor to the HEM-7251G and measured their HBP for two more weeks. Outcomes The primary outcomes were: (1) changes in home morning and evening BP before and after treatment; (2) changes in adherence to the HBP measurement protocol (calculated as the frequency of BP measurements in the latter half of the study (maximum frequency: 28) minus that in the first half (maximum frequency: 28)); and (3) the visual analog scale (VAS) scores as a measure of the motivation to perform HBP measurements (0=worst, 100=best). As secondary analyses, we also compared the changes in baPWV and UACR between the groups. Statistical Analysis All statistical analyses were carried out with SPSS for Windows version 11.0 (SPSS Inc, Chicago, IL). Data were expressed as mean (standard deviation) or as percentages. The chi-square test was used to calculate proportions. Unpaired t tests were used to compare variables between the Telemonitoring and Control 816
The Journal of Clinical Hypertension
Vol 16 | No 11 | November 2014
groups. A two-tailed P value
PAPER
Home BP Monitoring Using a Telemonitoring System is Effective for Controlling BP in a Remote Island in Japan Toshiki Kaihara, MD;1 Kazuo Eguchi, MD, PhD;2 Kazuomi Kario, MD, PhD2 From the Niijima-mura National Health Insurance Clinic, Tokyo;1 and Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan2
The purpose of this study was to assess whether a home blood pressure (HBP) telemonitoring system could improve BP control and overcome the problems of HBP monitoring in a remote location. The authors enrolled 60 subjects and randomized them to either a Telemonitoring group or a Control group. The outcomes were changes in HBP level, adherence to HBP monitoring, and visual analog scale (VAS; score 0–100) as a measure of the motivation to perform HBP measurements. The reductions in morning systolic BP ( 5.50.9 mm Hg vs 0.70.7 mm Hg, P140 mg/dL); (2) dyslipidemia (total cholesterol >240 mg/dL or the use of lipid-lowering drugs); (3) hypertension (while taking medication or office SBP >140 mm Hg or office DBP >90 mm Hg); (4) current smoking (within 1 year); (5) kidney disease (albuminuria or creatinine >1.1 mg/dL); (6) atrial fibrillation; (7) metabolic syndrome; (8) chronic obstructive pulmonary disease; and (9) sleep apnea syndrome. We measured subjects’ office BP consecutively three times at about 15second intervals16 with the patients in the sitting position after resting for 1 to 2 minutes on at least two different occasions following the guidelines of the Japanese Society of Hypertension.17 The exclusion criteria were as follows: (1) current residence anywhere other than Niijima (or living off Niijima more than half of the year); (2) ischemic heart
disease; (3) stroke (except asymptomatic and transient); (4) aortic dissection; (5) peripheral artery disease; (6) heart failure requiring hospitalization within the past 6 months; (7) hemodialysis; (8) inability to provide informed consent, self-measure BP, or walk; and (9) presence of serious diseases other than those described in the inclusion criteria. We recorded employment status, sleeping time, waistto-hip ratio, upper arm diameter, medication status, family history of hypertension or other illness, current smoking, habitual drinking, past medical history, state trait anxiety inventory (STAI), and Beck depression inventory (BDI) for each subjects. Employment status was defined as working and receiving a salary. Habitual drinking was defined as drinking any alcohol every day or almost every day. Data on family history of hypertension, current smoking, alcohol intake, employment, and sleeping time were based mainly on self-reported information. The ethics committees of the internal review board at Jichi Medical University School of Medicine, Tochigi, Japan, approved the protocol (clinical category #13-02). All subjects were ambulatory and all gave written informed consent to participate in the study. Measurements In this study, subjects used automated oscillometric HBP monitors. They used conventional BP monitors (HEM7080IC; Omron Healthcare Co, Kyoto, Japan) or BP monitors with a telemonitoring system that stored and transmitted data to a secure Web site (HEM-7251G, Omron Healthcare Co). The HEM-7080IC device has an algorithm equivalent to that in the HEM-705IT, which was validated in an international protocol.18 The HEM7251G is also a validated automated oscillometric device.19 When using the HEM-7080IC, subjects manually recorded their HBP data at the same time that their HBP data were input into their device, which we were able to confirm. On the other hand, the HEM-7251G received acquired physiological data (BP, pulse rate [PR]) wirelessly and transmitted them to the central Web server via the Internet. We were thus able to check the data of subjects using the HEM-7251G in real time. Subjects measured their HBP consecutively three times at about 15-second intervals in the morning and evening. The 15-second interval was validated in a previous study,16 and the same interval was used in our recent publication of the Japan Morning Surge—Home Blood Pressure (J-HOP) study.20 In the morning they measured HBP within 1 hour after rising (after urination and breakfast and before taking medicine), and in the evening they measured their HBP in the sitting position before sleeping and after resting for 1 to 2 minutes following the guidelines of the Japanese Society of Hypertension.17 The baseline HBP data used in the analyses were the first measurement only, but subsequent HBP data were the average of three times. Office BP was measured by conventional BP monitors (HEM-7080IC, Omron Healthcare Co) consecutively The Journal of Clinical Hypertension
Vol 16 | No 11 | November 2014
815
Home BP Telemonitoring in Japan | Kaihara et al.
three times at about 15-second intervals on the first day, 14th day, and 28th day following the guidelines of the Japanese Society of Hypertension. The baseline office BP data used in the analyses were also only the first-time measurement. Subjects collected urine samples in the morning on the first day and on the 28th day. The urine samples were frozen immediately after collection, and periodically transported to SRL Inc (Tokyo, Japan), where urinary microalbumin was measured. The urinary albumin per creatinine ratio (UACR) was calculated by the same laboratory. Arterial stiffness was assessed by brachial-ankle pulse wave velocity (baPWV). The baPWV was measured using a volume-plethysmographic device with four cuffs fitted with oscillometric sensors (form BP-203RPE II; Omron Colin Co, Ltd, Tokyo, Japan) at the same time as the UACR measurements. Study Design This study was a prospective, randomized, open, and comparative investigation of two different methods of HBP measurement. After confirming eligibility and obtaining informed consent, subjects were assigned to either a Telemonitoring group or a Control group. The subjects were randomized by a random number table in the research office of Jichi Medical University. An assigned doctor was given the allocation results by telephone or e-mail at enrollment. During the study period, we did not change any antihypertensive medications. All subjects received and used the conventional HBP monitor (HEM-7080IC) first and were instructed to measure their HBP as many days as possible. They brought the HBP monitor to the clinic 2 weeks later. After getting the allocation results, the Control group continued the HBP measurements using the same HBP monitor for two more weeks. The Telemonitoring group changed HBP monitor to the HEM-7251G and measured their HBP for two more weeks. Outcomes The primary outcomes were: (1) changes in home morning and evening BP before and after treatment; (2) changes in adherence to the HBP measurement protocol (calculated as the frequency of BP measurements in the latter half of the study (maximum frequency: 28) minus that in the first half (maximum frequency: 28)); and (3) the visual analog scale (VAS) scores as a measure of the motivation to perform HBP measurements (0=worst, 100=best). As secondary analyses, we also compared the changes in baPWV and UACR between the groups. Statistical Analysis All statistical analyses were carried out with SPSS for Windows version 11.0 (SPSS Inc, Chicago, IL). Data were expressed as mean (standard deviation) or as percentages. The chi-square test was used to calculate proportions. Unpaired t tests were used to compare variables between the Telemonitoring and Control 816
The Journal of Clinical Hypertension
Vol 16 | No 11 | November 2014
groups. A two-tailed P value
