Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 17, 2021
Open Peer Review Period: Jan 27, 2021 - Mar 24, 2021
Date Accepted: Mar 30, 2021
(closed for review but you can still tweet)
A Wireless Home Blood Pressure Monitoring System with Automatic Outcome-based feedback and Financial Incentives to improve Blood Pressure outcomes in people with Hypertension: Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Hypertension is prevalent in Singapore and is a major risk factor for cardiovascular morbidity and mortality and increased healthcare costs. A strategy is to lower blood pressure (BP) through lifestyle modifications and home BP monitoring (HBPM). Nonetheless, adherence to HBPM remains low.
Objective:
The objective of the Wireless monitoring and Financial incentives for uncontrolled Hypertension (WiFHy) study is to determine whether a Wireless HBPM System with and without financial incentives is effective at reducing systolic BP (SBP) compared to a non-wireless HBPM (usual care).
Methods:
WiFHy is a randomized, controlled, open-label, superiority study. The sample size of 224 was computed to detect differences of 10 mmHg in average SBP. Participants were to be randomized into one of three parallel study arms: (1) Usual care, (2) Wireless HBPM System and (3) Wireless HBPM System with financial incentives, in the ratio of 2:3:3. The primary outcome was the mean change in SBP at Month 6. The secondary outcomes were the mean reduction in DBP, cost of financial incentives, time taken for the intervention and adherence to HBPM, effectiveness of the framing of financial incentives in decreasing non-adherence to BP self-monitoring and the adherence to most-frequently used anti-hypertensive at month 6.
Results:
Due to unforeseen events the study was stopped prematurely. Therefore, no results are available.
Conclusions:
This protocol details an algorithm for remote management of primary care patients with hypertension. Depending on the BP information received from the patients, the algorithm can trigger immediate BP advice (e.g. Accident and Emergency department visit advice for extremely high BP), weekly feedback on BP 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. Clinical Trial: ClinicalTrials.gov registry, ID: NCT 03368417. Registered on 11th December 2017. (https://clinicaltrials.gov/ct2/show/NCT03368417).
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