CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 333 enrolled
Drug / intervention
Hypertension Coaching Application and Home Monitor +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT03288142N/ACompleted
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Improving Hypertension Using a Smartphone-Enabled Personal Control Program: The Smart Hypertension Control Study

Northwestern University·interventional·Posted Sep 19, 2017·Updated Apr 15, 2022

In Brief

A clinical study evaluating Hypertension Coaching Application and Home Monitor and Control: Tracking Application and Home Monitor for Hypertension. Completed, enrolled 333 participants across 1 site.

Detailed Summary

Investigators at Northwestern University will partner with Omron Healthcare Co., Ltd. (hereinafter referred to as "Omron") to conduct a randomized controlled trial of a hypertension personal control program (HPCP), known as Lark HTN Pro with a home blood pressure monitoring device (HBMD) compared to a HBMD alone. The overarching goal of this study is to investigate the effects of the HPCP on blood pressure, blood pressure self-management behaviors, and healthy lifestyle behaviors among adults with hypertension.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesUnited States
CollaboratorsOmron Healthcare Co., Ltd.

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 19, 2017
Enrollment StartSep 21, 2017
Primary CompletionApr 28, 2019
Study CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.8 years ago

Interventions

Hypertension Coaching Application and Home Monitorother

The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD

Control: Tracking Application and Home Monitorother

Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.