Wireless Home Blood Pressure Monitoring System With Automatic Outcome-Based Feedback and Financial Incentives to Improve Blood Pressure in People With Hypertension: Protocol for a Randomized Controlled Trial.

Marcel Bilger,Ngiap Chuan Tan,Ada Portia M Batcagan-Abueg,Agnes Ying Leng Koong,Juliana Bahadin,Ian Kwong Yun Phoon,Joann Bairavi,Eric A Finkelstein

doi:10.2196/27496

Abstract

BackgroundHypertension is prevalent in Singapore and is a major risk factor for cardiovascular morbidity and mortality and increased health care costs. Strategies to lower blood pressure include lifestyle modifications and home blood pressure monitoring. Nonetheless, adherence to home blood pressure monitoring remains low. This protocol details an algorithm for remote management of primary care patients with hypertension.ObjectiveThe objective of this study was to determine whether wireless home blood pressure monitoring with or without financial incentives is more effective at reducing systolic blood pressure than nonwireless home blood pressure monitoring (usual care).MethodsThis study was designed as a randomized controlled open-label superiority study. A sample size of 224 was required to detect differences of 10 mmHg in average systolic blood pressure. Participants were to be randomized, in the ratio of 2:3:3, into 1 of 3 parallel study arms :(1) usual care, (2) wireless home blood pressure monitoring, and (3) wireless home blood pressure monitoring with financial incentives. The primary outcome was the mean change in systolic blood pressure at month 6. The secondary outcomes were the mean reduction in diastolic blood pressure, cost of financial incentives, time taken for the intervention, adherence to home blood pressure monitoring, effectiveness of the framing of financial incentives in decreasing nonadherence to blood pressure self-monitoring and the adherence to antihypertensive medication at month 6.ResultsThis study was approved by SingHealth Centralised Institutional Review Board and registered. Between January 24, 2018 and July 10, 2018, 42 participants (18.75% of the required sample size) were enrolled, and 33 participants completed the month 6 assessment by January 31, 2019.ConclusionsDue to unforeseen events, the study was stopped prematurely; therefore, no results are available. Depending on the blood pressure information received from the patients, the algorithm can trigger immediate blood pressure advice (eg, Accident and Emergency department visit advice for extremely high blood pressure), weekly feedback on blood pressure monitoring, medication titration, or skipping of routine follow-ups. The inclusion of financial incentives framed as health capital provides a novel idea on how to promote adherence to remote monitoring, and ultimately, improve chronic disease management.Trial RegistrationClinicalTrials.gov NCT 03368417; https://clinicaltrials.gov/ct2/show/NCT03368417International Registered Report Identifier (IRRID)DERR1-10.2196/27496

Highlights

Hypertension is prevalent in Singapore, affecting 23.5% of adults between 18 to 69 years of age [1]
The secondary outcomes were the mean reduction in diastolic blood pressure, cost of financial incentives, time taken for the intervention, adherence to home blood pressure monitoring, effectiveness of the framing of financial incentives in decreasing nonadherence to blood pressure self-monitoring and the adherence to antihypertensive medication at month 6
Depending on the blood pressure information received from the patients, the algorithm can trigger immediate blood pressure advice, weekly feedback on blood pressure monitoring, medication titration, or skipping of routine follow-ups

Summary

Introduction

Hypertension is prevalent in Singapore, affecting 23.5% of adults between 18 to 69 years of age [1] It is a major risk factor for cardiovascular morbidity and mortality [2,3] and is associated with significant health care cost [4,5]. Systematic reviews [19,20] on telemonitoring reveal that it produces only modest improvements, which suggests that other features are needed [21,22,23,24,25] Features such as automatic reminders [26,27], weekly feedback [28], or clinical interventions in response to concerning blood pressure trends (eg, medication titration), and financial incentives can be considered. This protocol details an algorithm for remote management of primary care patients with hypertension

Methods

Results

Discussion

Conclusion