The Smart Hypertension Control Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 1/13/2019 |
| Start Date: | September 21, 2017 |
| End Date: | April 20, 2019 |
Improving Hypertension Using a Smartphone-Enabled Personal Control Program: The Smart Hypertension Control Study
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.
(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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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