Status:
COMPLETED
The Smart Hypertension Control Study
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Omron Healthcare Co., Ltd.
Conditions:
Hypertension
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 p...
Detailed Description
The study team used structured language queries of electronic health record data from the Northwestern Medicine Enterprise Data Warehouse (NMEDW) to identify potentially-eligible participants with ele...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
333 Patients enrolled
Trial Details
Trial ID
NCT03288142
Start Date
September 21 2017
End Date
December 1 2019
Last Update
April 15 2022
Active Locations (1)
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1
Northwestern Medical Group
Chicago, Illinois, United States, 60611