Patient Randomization and Trial Implementation
BLOOD
Patients were randomized 1:1 to the intervention and control groups based on a computer-generated series of numbers using Excel’s random macro function and sequentially numbered, opaque, and sealed envelope technique [Patients in the intervention group were required to download Blood Pressure Assistant onto their smartphones by scanning a QR code. The nurse then provided the participants with 10 to 15 minutes of training regarding the method to navigate and use the available functional modules of Blood Pressure Assistant and asked them to use it for 6 months.The control group was managed on the basis of recommendations by the Participants in both groups were required to measure their BP using their own sphygmomanometer and record the results on the app (intervention group) or in a notebook (control group) at home twice a day: 1 recording conducted between 6 and 9 AM, after bladder voiding and before taking antihypertensive medications, and another conducted between 6 and 9 PM, after dinner and before sleeping.To ensure the accuracy and reliability of these devices, participants in both groups were trained by a nurse in the proper use and maintenance of the BP devices, including proper cuff size and placement; positioning of the arm at the heart level; allowing for a resting period before taking a measurement; and avoiding caffeine, exercise, or stress, before taking a reading. They were also asked to periodically compare readings with those taken during their clinic visit. If discrepancies were noticed, they were requested to recalibrate the sphygmomanometer.The “health manager” team conducted a follow-up telephone call with participants in both groups at 3 months. For the intervention group, when the system detected abnormal BP readings or patient-reported discomfort and prolonged nonuse of the app (1 month), the web-based portal would automatically send out a warning signal, alerting the team to conduct follow-up phone calls to provide appropriate assistance. Participants in the control group were generally directed to continue their normal activities and follow any medical advice or treatment recommendations they received from the health professionals in the training session. They were also advised to call the management team for advice or to seek medical attention immediately if their home BP readings were too high or too low.