Simplified regimen for the management of hypertension with telemedicine and blood pressure self-monitoring (SIMPLE): study protocol for a randomised controlled trial

Abstract

IntroductionTelemedicine and blood pressure (BP) self-monitoring conduces to management of hypertension. Recent hypertension guidelines highly recommended single pill combination (SPC) for the initial treatment of essential hypertension. Based on this fact, an SPC-based telemedicine titration regimen with BP self-monitoring could be a better way in managing hypertension. This trial aims to elucidate whether telemedicine combined with BP self-monitoring is superior to self-monitoring alone during hypertension management.Methods and analysisThis study will be a multicentred, open-labelled, randomised controlled trial. A minimum sample of 358 hypertensive patients with uncontrolled BP from four centres will be included. The intervention group will include BP self-monitoring and tele-monitoring plus a free SPC-based telemedicine titration therapy for 6 months, they will be recommended to take BP measurements at least once every 7 days, in the meantime, researchers will call to give a consultation on lifestyle or titration advice once a fortnight. The control group will be required to self-monitor BP at the same time interval as intervention group, without any therapy change. Primary outcome of the trial will be the difference in systolic blood pressure at 6-month follow-up between intervention and control group, adjusted for baseline variables. Secondary outcomes such as BP control rate, major adverse cardiovascular events, medication adherence, quality of life will be investigated.Ethics and disseminationEthics approval was granted by Ethical Committee of Shanghai Tenth People’s Hospital (SHSY-IEC-4.1/20-194/01). The results will be disseminated in peer-reviewed literature, and to policy-makers and healthcare partners.Trial registration numberChiCTR2000037217.

Tracking Pregnancy Complications and Engagement with Remote Patient Monitoring in Prenatal Care: Retrospective Review (Preprint)

“…Chart review followed established guidelines, including structured data sheets, abstractor training, and approximately 10% second abstractor check. [8] The primary outcome was the development of preeclampsia (PEC). Secondary outcomes included a composite of pregnancy-related complications.…”

“…4 Patients have described easier communication, reduced overall cost, and fewer missed in-person appointments. [5][6][7][8] The COVID-19 pandemic accelerated the use of RPM, digital health tools, and telemedicine across a wide variety of medical fields with potential benefits including a reduced time to diagnosis and improved access to specialist care. [8][9][10][11][12][13][14] In addition, remote technology allows for higher-frequency data collection compared to traditional in-person office visits.…”

“…[5][6][7][8] The COVID-19 pandemic accelerated the use of RPM, digital health tools, and telemedicine across a wide variety of medical fields with potential benefits including a reduced time to diagnosis and improved access to specialist care. [8][9][10][11][12][13][14] In addition, remote technology allows for higher-frequency data collection compared to traditional in-person office visits. 13 The increased data collection has the potential to lead to more accurate predictors of pregnancy complications and provide more timely feedback to physicians and patients.…”