Remote Blood Pressure Management Clinical Application Research
Phase: NA
Conditions: Hypertension
Sponsor: The Affiliated Hospital of Qingdao University

 
 
 
Remote Blood Pressure Management Clinical 
Application Research 
A 24-month multicenter randomized controlled trial 
 
 
 
 
 
 
 
 
 
 
study protocol 
 
 
 
 
 
 
 
 
 
 
Affiliated Cardiovascular Hospital of Qingdao University 
Qingdao, Shandong, China 
May 1, 2020 
 
 
 
 

 
Research on Clinical Application of Remote Blood Pressure Management 
study protocol 
Item Number: 20-3-4-54-nsh 
Technology Field: Population and Health 
Project initiation time: 2020-06     Closing time: 2023-06 
Project leader: Yu Haichu          Phone and mobile phone: +8618661809671 
Project contact person: Yu Haichu   Phone and mobile phone: +8618661809671 
Undertaking Unit: The Affiliated Cardiovascular Hospital of Qingdao University 
Corporate code: 123700004274066162 
Supervisor: Cardiovascular Hospital of Qingdao University 
Unit Address No. 5 Zhiquan Road, Shinan District, Qingdao 
 
1. Main research content 
①Project research objective  
Remote blood pressure management for patients with hypertension, 
②Project research content and task breakdown  
Recruit of essential hypertension patients who are randomly divided into three 
groups. One group uses the remote blood pressure management platform to realize 
automatic upload of patient measurement data, intelligent analysis, and early warning 
reminders; one group distributes electronic sphygmomanometers, and patients record 
blood pressure by themselves; one group performs routine community hypertension 
management. For 24 months follow-up, observe the patient's blood pressure level, 
blood pressure compliance rate, risk assessment, etc.  
③The main technical difficulties and problems to be solved  
A large-scale popularization of the remote blood pressure management mode 
based on the “cloud sharing smart cabinet”.  
④Innovation point 
Provide a smart, simple and efficient innovative tool for chronic disease 
management of residents for primary hospitals, and promote the improvement of 
chronic disease management in my country .Use smart terminal equipment to realize 
automatic data collection and transmission to ensure that patient blood pressure data 
timely and continuously .Provide data reference and basis for academic research and 
chronic disease prevention and control, and promote the transformation of scientific 
research results of chronic disease prevention and treatment in my country. 
 
2. Project acceptance content and assessment indicators 
①Main technical indicators 
Subject papers and reports: Four English papers, Four Chinese papers, Four 
international conference reports, and Six domestic conference reports 
②Talent team construction 
The project is committed to building an intelligent hypertension comprehensive 
detection and management network system from department-in-hospital-superior 
hospitals to promote the integration and shared utilization of resources in medical 

institutions. Improve the scientific research ability and level of primary medical staff 
by participating in research projects. Cultivate a group of backbone forces for the 
prevention and treatment of hypertension and related diseases for the grassroots. 
③Social and economic benefits 
Through the continuous collection of blood pressure data and cloud storage of 
wearable devices, the patient-related monitoring data is transformed from single-point 
data to time-based data. Analyze and observe the law of data fluctuations, combine 
the analysis of related data trends in the cloud and a large number of related 
characteristics, evaluate the risk of illness, and provide suggestions for changing the 
corresponding living habits. It is expected that the blood pressure compliance rate of 
patients with hypertension and chronic diseases will be increased by about 15%.The 
risk score of patients will be reduced, and medical expenses will be saved. Through 
the “Cloud Sharing Smart Cabinet”, the electronic sphygmomanometers that have 
been certified for clinical accuracy will be better popularized, and patients with 
hypertension will be more aware of importance of family blood pressure monitoring. 
The remote blood pressure management of the "Cloud Sharing Smart Cabinet" has the 
feasibility of large-scale promotion, which is transformed into products for promotion 
through scientific research projects.  
④Other evaluation indicators 
Compile the researcher's manual and CRF tables; customize the cloud sharing 
smart cabinet; determine the subject center unit, project training, complete the 
baseline survey; follow-up and intervene patients as planned; mid-term summary of 
the subject; monitoring at any time; conclusion and recall CRF tables, complete 
statistical analysis, write final report; write academic papers and conference reports 
 
3. Project mid-term evaluation indicators  
①Main technical indicators 
Subject papers and reports: one English paper, two Chinese papers, and one 
international conference report, two domestic conference report: 
②Application demonstration indicators 
The number of using cloud sharing smart cabinets accounts for about 50% of the 
total number. The number of blood pressure patients enrolled in the remote group, 
non-remote group and routine group is no less than 1050; All the patients have 
completed the cardiovascular risk assessment, completed the baseline survey and are 
enrolled in the group for treatment .The blood pressure compliance rate of patients at 
the remote group with hypertension and chronic diseases will be increased by about 
15% compared with the routine group. 
 
4. Project annual plan and assessment indicators 
2020 
2020.06-2020.08 
Compile researcher’s manual and complete the printing of 1050 CRF tables; 
customize the cloud sharing smart cabinet (maximum matching according to the 
funding situation). 

2020.09-2020.12  
Determine the subject center unit, project training, implement the cloud sharing 
smart cabinet and other equipment to be put in place, enroll patients and complete 
baseline survey, conduct risk assessment. 
2021 
2021.01-2020.03  
At least 1050 patients in the remote group, non-remote group, and routine group 
were enrolled in the group. 
2021.04-2021.12  
Follow up and intervene patients as planned. Blood pressure measurement in the 
office will be performed every 3 months, and CRF tables will be entered in time. It is 
expected to be carried out around mid-term summary of the subject at December 
2020. 
2022 
2022.01-2022.12  
Follow-up and intervene patients as planned, perform office blood pressure 
measurement every 3 months, and CRF tables will be entered in time. 
2023 
2023.01-2023.03  
Follow up and intervene patients as planned, and measure blood pressure in the 
office every 3 months, and CRF tables will be entered in time. By the end of March 
2023, all patients will complete follow-up and risk assessment will be performed 
again.  
2023.04-2023.06  
Finish the project, collect the CRF tables, complete the statistical analysis, write 
the final report, write the academic paper and conference report.