The Smart Hypertension Control Study

Completed · Not applicable

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT03288142

Run by

Northwestern University

People needed

333

Starts

2017-09-21

Expected to finish

2019-12-01

Last updated by the study team

2022-04-15

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18 years to <85 years at the time of screening
• Standardized mean blood pressure measurement ≥135 to <180 mmHg systolic or ≥85 to <110 mmHg diastolic
• Have and use an iOS device(s) (iPhone generation 5s or newer)
• Able to provide written informed consent prior to participation in the study
• Receive their primary care from a Northwestern Medicine clinic site

You may not qualify if…

• Current user of the HCPC (Lark HTN Pro)
• Standardized mean blood pressure measurement ≥180 mmHg systolic or ≥110 mmHg diastolic
• Persistent atrial fibrillation as indicated in the electronic health record (EHR)
• Pregnant or planning to become pregnant during the study period
• Severe kidney disease, defined as estimated glomerular filtration rate <30 per 1.73 m2 or currently on renal replacement therapy (i.e. hemodialysis or peritoneal dialysis)
• Hearing impaired and unable to respond to phone calls
• Lack of fluency in English
• History of a cardiovascular event (stroke, transient ischemic attack, myocardial infarction, coronary artery bypass grafting) in the past 3 months
• Diagnosis of dementia as indicated in the electronic health record
• Diagnosis of psychosis as indicated in the electronic health record
• Terminal cancer diagnosis or NYHA III or IV heart failure
• Deemed unsuitable for study by primary care provider
• Individuals requiring BP monitor cuff size larger than 17 inches or 42cm

Where it is running

• Northwestern Medical Group — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.