|CLINICAL REGISTRY STUDY
|Year : 2018 | Volume
| Issue : 4 | Page : 117-121
Comparing an internet-based medical model with a conventional medical model in the management of patients with hypertension in China: Methodology of a cluster randomized study
Jie Jiang1, Ningling Sun2, Jianping Li1, Xinhua Zhang3, Bei Shi4, Chen Yao5, Dong Zhao6, Hongwei Sun7, Shengyuan Wu7, Chengming Gu8, Yong Huo1
1 Department of Cardiology, Peking University First Hospital, Beijing, China
2 Department of Cardiology, Peking University People's Hospital, Beijing, China
3 Chinese Hypertension League, Beijing, China
4 Department of Cardiology, Affiliated Hospital of Zunyi Medical College, Beijing, China
5 Medical Statistic Room, Peking University First Hospital, Beijing, China
6 Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
7 Department of Chronic Disease, Kaili Municipal Health and Family Planning Bureau, Beijing, China
8 Department of Medical, Pfizer Investment Co., Ltd, Beijing, China
|Date of Web Publication||19-Dec-2018|
Peking University First Hospital, Beijing
Source of Support: None, Conflict of Interest: None
Background: The awareness, treatment, and control of hypertension are low in China. New and effective management model other than conventional hospital-based practices is needed to optimize the assessment and treatment of hypertension. Objectives: The objective of the study is to design a study that compares blood pressure (BP) control rate in hypertensive patients managed through an internet-based medical model versus conventional medical model. Methods: The study designed is a cluster randomized, unblinded controlled study which will be performed in 14 primary care clinics in Guizhou Province in southwest China. Sites will be randomized to provide BP management services to the patient through an internet-based medical model including home BP monitoring (HBPM) and telemonitoring by primary care physicians, or through a conventional medical model including HBPM and periodical visits to the clinic. Patients aged 45–75 years with two measurements of resting systolic BP (SBP) ≥140 mmHg and/or diastolic BP (DBP) ≥90 mmHg on different days during screening will be enrolled. The primary endpoint is the BP control rate, defined by the percentage of patients achieving target office BP (SBP <140 mmHg and DBP <90 mmHg). Using a superiority design, at least 958 patients were calculated to be sufficient to detect a 10% difference in BP control rate between groups, with a power of 85% and 15% drop out rate. Other outcomes include BP value, BP variability, treatment compliance, medical expense, and treatment satisfaction. Discussion and Conclusion: The results of the trial will be applicable to primary care services in China, especially in the west of China, where medical resources are less readily available. If successful, the internet-based management model with HBPM and telemonitoring from primary care physician may help to improve the BP control in patients in China. Clinical.gov Registration: NCT03527563.
Keywords: Hypertension, internet, self-management, telemonitor
|How to cite this article:|
Jiang J, Sun N, Li J, Zhang X, Shi B, Yao C, Zhao D, Sun H, Wu S, Gu C, Huo Y. Comparing an internet-based medical model with a conventional medical model in the management of patients with hypertension in China: Methodology of a cluster randomized study. Cardiol Plus 2018;3:117-21
|How to cite this URL:|
Jiang J, Sun N, Li J, Zhang X, Shi B, Yao C, Zhao D, Sun H, Wu S, Gu C, Huo Y. Comparing an internet-based medical model with a conventional medical model in the management of patients with hypertension in China: Methodology of a cluster randomized study. Cardiol Plus [serial online] 2018 [cited 2019 May 25];3:117-21. Available from: http://www.cardiologyplus.org/text.asp?2018/3/4/117/247954
| Introduction|| |
Hypertension is the most common chronic disease worldwide and the most important risk factor for the occurrence of heart disease, cerebrovascular disease, and renal disease, and associated mortality from these diseases. Report on Cardiovascular Disease in China (2017), reveals that the prevalence of hypertension in Chinese adults is 25.2%. Cardiovascular and cerebrovascular disease has become the leading cause of death in China, and hypertension is an associated risk factor in more than half of the cases. Therefore, hypertension control becomes one of the main targets for the prevention of cardiovascular and cerebrovascular disease.
Despite the high prevalence of hypertension in China, the awareness, treatment, and control rate of hypertension are still at a low level. The assessment and treatment of hypertension is far from adequate in current practice, where blood pressure (BP) evaluation is not routinely practiced. there is often delayed prescription of antihypertensive medication, and low treatment compliance. Given that China is a vast and populated country, new and effective management model other than the conventional hospital-based practice is needed to optimize the assessment and treatment of hypertension.
Home BP monitoring (HBPM) has been applied rapidly in recent years and has significantly increased BP testing and monitoring. European Society of Hypertension Practice Guidelines for home blood pressure monitoring indicates that HBPM is helpful in improving the patient attitudes to BP management and awareness, but it is difficult to assure the quality of the measurement. Inaccurate and incomplete results could lead to increased patient anxiety and changes in BP management at the discretion of patients and their preferences. Thus, the proper use of HBPM relies heavily on a remote monitoring system which involves both the patients and their physicians to ensure the quality and efficiency of self-monitoring. This study will involve a process in which the users' BP data are uploaded to an online network, where their BP data is analyzed and provided to the physician, who will assess the patient's health condition and recommend appropriate diagnosis and treatment. This way, a self-monitoring system which involves both the patients and their physicians might be useful to ensure the quality and efficiency of HBPM.
The rapid development of technology during the past decade provides an opportunity to change the conventional medical model in hypertension management. The proposed internet-based technique allows for a telemedicine system which integrates hospital resources, health service providers, as well as patients and their self-monitoring devices. With the help of this kind of platform, we hope to provide integrated, continuous, and personalized medical services while limiting conventional barriers in space and time.
Currently, patients' treatment plans are decided by physicians on the basis of casual BP measurements in the clinic. There are several weaknesses of this conventional model of patient management. First, the long-term trend and daily variation in patients' BP is not considered, and this is strongly recommended by the current guidelines. Second, in areas where patients cannot reach their physician easily unless the visit is planned well in advance, delays in treatment modification occur. Third, the dissemination of patient education information related to hypertension treatment is often not achieved by the current management model. Through an internet-based medical model, we hope to strengthen these points and provide better services for patients.
A recent review summarized the facilitators and barriers associated with the implementation of telehealth in the self-management of hypertension. The top facilitating themes included increased access to medical services, increased health quality, increased patient knowledge and involvement, and of course the technology growth with remote monitoring. On the other hand, the barriers mentioned most often were lack of evidence and difficulties in maintaining self-management. At present, understanding the benefits of internet-based health care is still in the initial stage. There is no report on the effectiveness of internet-based medical models among a Chinese hypertensive population. In addition, there is no study comparing an internet-based medical model and a conventional medical model.
The proposed study aims to explore the effect of an internet-based hypertension management model on BP control in China, comparing with a conventional management model. An integrated management mode will be adopted to provide complete triage treatment solutions based on internet technology and build a closed-loop medical model. The methodology for this study will be described here.
The primary objective of this study is to compare the BP control rate between hypertensive patients managed by an internet-based medical model and a conventional medical model.
Secondary objectives include: to compare the BP value, change of BP value from baseline, treatment compliance, medical expenses, and treatment satisfaction between the internet-based medical model group and the conventional medical model group.
| Study Design and Methods|| |
Sites will be randomized to provide their services for either an internet-based medical model or conventional medical model. Each site will provide 6 months of BP management for enrolled patients with hypertension. BP control rate will be compared between groups after 6 months of management.
The sites have been selected from two counties in Guizhou Province in the Southwest of China. The 14 primary care clinics include township hospitals which are located in rural area and community health service centers in urban areas. Typically, each clinic provides medical services to most of the residents in a designated area nearby. The study subjects will be enrolled from those patients. Clinics will be blocked by their setting (township hospitals or community health service centers) to balance the potential impact of differences between town and city.
Subjects may be enrolled into the study only if they meet all of the following criteria: male or female, 45–75 years old; two measurements of resting systolic BP (SBP) ≥140 mmHg and/or diastolic BP (DBP) ≥90 mmHg on different days during screening; subjects who can understand and perform HBPM as required by the study; subjects who voluntarily participate in the study and sign informed consent form.
Exclusion criteria include
Two measurements of resting SBP ≥180 mmHg and/or DBP ≥110 mmHg on different days during screening; history of cerebral stroke within 6 months before screening; history of myocardial infarction within 6 months before screening; history of heart failure; history of atrial fibrillation; history of coronary artery revascularization; other serious diseases, such as tumor; subjects diagnosed with secondary hypertension; subjects with congenital or acquired organic heart disease; pregnant or lactating subjects; subjects with severe mental disease; abnormal liver and renal function: ALT or AST >2 times the upper limit of normal; creatinine >2 times the upper limit of normal; previously diagnosed diabetes that is poorly controlled at the time of screening (fasting blood glucose >10 mmol/L); unable to conduct BP self-test; any other known condition at screening that would compromise subject safety, might affect life expectancy, or making it difficult to successfully manage and follow the subject according to the protocol.
Intervention and grouping
The study randomization will be done at the level of the primary care clinic. Participating sites will be randomized to the internet-based medical model group (internet group) or the conventional medical model group (conventional group) before the beginning of the study. All patients enrolled in a site will be managed with the single model which the site was randomized to.
In the Internet BP management model group, patients perform HBPM. The BP data will automatically upload to the cloud data center. Online physicians will formulate or adjust treatment regimen based on the real-time data of the subjects, and communicate with them through an internet platform according to a predefined plan. Patient education materials will be provided through the internet platform during the follow-up. A standardized Internet physician team should be established for this model, and training on how to use the internet platform will be done before the start of the study.
In the conventional BP management model group, patients will perform HBPM, and the data will be automatically uploaded to the data center as well. The physician will only have access to review the home-monitoring data when the patient comes to the hospital for an onsite visit. The physician will give advice on anti-hypertensive treatment during the visit. Printed patient education materials will be given to patients at the beginning of the study and during each visit, with the same content given to the intervention group through the internet.
A self-designed internet platform (provided by Shenzhen Raycome Health Technology) will be used in this study. This will include a web-based database as well as an application for mobile phone. Besides the storage of patients' BP data and support of physician-patient communication, an automatic warning mechanism is another part of the system. The system will submit warning information for physicians to review if there are missing data for 3 out of 7 days, or abnormal BP on 2 of 3 consecutive days. The warning threshold for BP set in the system is SBP ≥180 mmHg or ≤100 mmHg and DBP ≥110 mmHg or ≤60 mmHg.
After enrollment, subjects and physicians communicate through telephone or internet every 2 weeks until BP is well controlled judged by physician. The frequency of communication is then changed to once a month. Once a warning is created, the physician will contact the patient for disease inquiry. Patients can regularly communicate with physicians through the internet via messages, videos, and so on.
Home monitoring of blood pressure
The study will use an electronic BP meter (Sphygmomanometer model, manufacturer/RBP-9801, Shenzhen Raycome Health Technology) approved by international standards and with the ability to automatically transmit data. All subjects will use a uniform electronic BP meter to monitor BP including office and HBPM throughout the study. Detailed instructions on how to use the electronic BP meter will be given to patients in the form of a paper book, and online for the internet group. Face to face training on how to use the BP meter will be done at the time of enrollment by the site research coordinator.
Patients' anti-hypertensive treatment regimen will be decided by the investigator based on patients' clinical conditions. For antihypertensive medication, angiotensin-converting enzyme inhibitors, angiotensin II receptor blocker, calcium ion antagonist (Calcium channel blocker) and diuretics are recommended.
The primary efficacy endpoint of the study is the BP control rate at month 6. BP control rate is defined as the percent of subjects with SBP <140 mm Hg and DBP <90 mmHg.
The secondary efficacy endpoints of the study include: BP control rate at month 3; BP value at months 3 and 6; change of BP from baseline at months 3 and 6; BP variability (BPV) at months 3 and 6; treatment compliance of subjects at months 3 and 6, medical expenses of subjects at months 3 and 6, and treatment satisfaction of subjects in the two groups at months 3 and 6.
Measurement of the endpoints
The BP value used for the primary and secondary endpoints will be the value acquired during face to face visits in the hospital clinic. BP measurement will be done according to the 2018 National Grassroots Hypertension Management Guide. The BP will be measured by trained site staff. Before measurement, the subject should rest for at least 5 min in the sitting position, with an empty bladder. Smoking or drinking coffee/tea will not be allowed within 30 min before measurement. For a patient with suspected peripheral vascular disease, BP of both upper arms will be measured for the first time. Afterward, the upper arm with higher BP reading will be used for any following measurements. The diagnosis of hypertension requires three measurements on different visit/days. Each measurement will include three consecutive readings taken at intervals of 1–2 min, and the lower of the latter two SBP readings recorded. For follow-up BP management measurements, if the first BP measurement ≥140/90 mmHg, a second measurement will be taken after 1–2 min. The reading with the lower SBP will be recorded.
Although BP measurements taken at primary and secondary endpoints will not be masked, the sphygmomanometer will be set in automatic mode, and the BP value will be automatically transmitted to the data center. The contribution of the investigator will be to place the cuff on the patient and switch the device on.
BPV is defined as within-subject standard deviation of home BP value during the previous 3 consecutive months. Systolic BPV and diastolic BPV will be calculated separately. For HBPM, the general requirements will be similar to those receiving office BP monitoring. Before self-monitoring of home BP, the subject will be trained by trained site staff. Subjects will be asked to upload BP monitoring data at least once per day. Patients will be highly encouraged to upload two pressure monitoring results per day.
A self-designed satisfaction scale will be used for the assessment of patient satisfaction.
In this study, an electronic data capture system will be used. The study data will be entered into the electronic data capture system by investigators or authorized staff on site. Before site initiation or data entry, investigators and authorized staff on site will be appropriately trained. Investigators must verify the accuracy and validity of all data entered in the eCRF.
Data of HBPM will be kept in the internet database platform used in this study. Only the patients have the right to input and modify their home BP values.
Sample size and statistics
According to the study of Margolis et al., the BP control rate of HBT and UC group was 71.8% and 45.2%, respectively at month 6 after the intervention. The rate difference was 26.6%. A conservative estimate of the BP control rate and rate difference is utilized in consideration of the condition of Chinese patients. Presuming the BP control rate of the control group is 30%, and the control rate difference is 10, with a superiority design and group ratio of 1:1, the number of subjects in each group is 407 with a power of 85%. Considering a 15% drop out rate, the sample size of this study is 958 totally, and 479 for each group.
Baseline data will be compared between the groups. T-test will be used for continuous data and Chi-square test for categorical data.
The primary endpoint will be the BP control rate of subjects in the two groups at month 6. According to the monitored data during follow-up, the Chi-square test will be used to compare whether there is a statistically significant difference in the BP control rate between the internet group and the conventional group. Comparisons between the two groups will also be conducted in subgroups of patients with different ages, sex, baseline BP, and history of diabetes. As supporting analysis, 6 months BP control rates will be further analyzed using multivariate regression adjusting for hypertension risk factors (age; sex; BMI; cigarette smoking; alcohol use; family history of hypertension; history of diabetes, coronary heart disease) and other factors that are significantly different between the two groups at baseline. The analytical method will be the same as that at the primary endpoint, as for the BP control rate of subjects at month 3.
T-test will be adopted to compare the differences in BP values between the two groups at month 3 and month 6. Similar statistical methods will be used to analyze BP changes from baseline to month 3 and month 6, as well as variability of long-term BP, treatment compliance, medical expenses, and treatment satisfaction at months 3 and 6. An ANOVA model will be utilized to adjust for other factors, as for the logistic regression model, as deemed necessary.
| Discussion|| |
Self-monitoring utilized for patients to measure their own physical health parameters is gaining importance in chronic disease management. Hypertension is among the group of chronic diseases with the highest patient willingness to engage in self-monitoring. HBPM has been tested for its role in long-term BP control in many clinical trials. A meta-analysis of 25 randomized controlled trials showed that office SBP and DBP were significantly reduced in those who self-monitored their BP compared to usual care, and self-monitoring increased the chance of meeting office BP targets. These studies had significant heterogeneity which could be partially accounted for by the use of different co-interventions in each study. A recent meta-analysis further reviewed previous studies based on the co-intervention used and come to the conclusion that self-monitoring worked best when combined with more intensive interventions such as self-management, systematic medication titration, or lifestyle counseling, but had little or no effect on its own.
With the help of the current informatic techniques, telemonitoring of home BP has been used in different studies, combined with intervention from medical care providers, or self-titration of medication. Home BP telemonitoring with pharmacist case management or consultation from nurses or doctors, achieved better BP control compared with usual care. McManus and his team did a series of clinical trials testing the use of self-management in BP control. In two of these studies,, telemonitoring of BP was used together with self-monitoring and self-titration for medication, in comparison with usual care with GP clinic visits and modification of treatment plan. The strategy involving telemonitoring showed better improvement in BP control.
Comparing with previous studies, the current study has several specific features. (1) The eligibility criteria and the enrollment process is designed to ensure that we enroll a population which is representative of patients with uncontrolled hypertension that are usually cared for by the primary care clinics in the area, and also incorporate the intervention into common practice. (2) The design of the study represents the current disease management and advancements in internet techniques. HBPM has been well recognized as a basic self-management tool for public health. Easy-to-use home BP meters and their automatic link to the internet are common in the market in China. Thus, in our study, the control group will use the same self-monitoring device and upload their BP value. This will unify the patient self-management behavior and slack down the difference of self-monitoring between groups and thus enforce the power to detect the advantage of internet management. (3) Specially designed patient education materials will be provide to both groups of patients, with the same content but the different route of administration, according to study groups. This will ensure that all patients have similar standards of knowledge regarding the treatment of their disease, as part of their management.
This study is a cluster randomized trial for which randomization will be done at the site level. This is a typical design for disease management studies, which avoids exposing the physician to patients from different study groups. Furthermore, the physicians in the control sites will not have access to the internet platform of the study.
Self-management support, clinical information systems, delivery system redesign, decision support, health-care organization, and community resources are the 6 key components that can produce system reform and can guide higher-quality chronic illness management within primary care. The internet-based medical model that will be employed used in our study will make an effort to incorporate these components based on the local situation and thus push forward continual reform of clinical service systems in the area following the completion of this study.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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