N/A
Completed N=333
The Smart Hypertension Control Study
Source: ClinicalTrials.gov NCT03288142 ↗Enrolled (actual)
333
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcomePrimary: Blood Pressure at 6 Months — 135.0; 132.3; 85.6; 85.1 mmHG
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Pressure at 6 Months |
135.0; 132.3; 85.6; 85.1 | — |
| PRIMARY Blood Pressure <140/90mmHg |
72; 78 | — |
| SECONDARY Number of Antihypertensive Agents Used |
1.3; 1.3 | — |
| SECONDARY Antihypertensive Medication Intensification, No. of Additions, Dose Increases, or Substitutions |
0.3; 0.4 | — |
| SECONDARY Number of Health System Contacts (Telephone, Office, or Mychart Encounters) |
7.0; 6.7 | — |
| SECONDARY Frequency of Home Blood Pressure Measurements Per Month |
16; 17 | — |
| SECONDARY Months When a Home Blood Pressure Reading is Obtained, No. |
4.9; 5.0 | — |
| SECONDARY Self-efficacy: Confidence in Controlling High Blood Pressure |
4.4; 4.1; 4.8; 4.7; 4.0; 4.0 | — |
| SECONDARY BMI |
32.0; 31.9 | — |
| SECONDARY Diet Quality Score (as Assessed by Dietary Approaches to Stop Hypertension Questionnaire, DASH-Q |
38.7; 39.3; 1.3; 1.5; 1.0; 1.1 | — |
| SECONDARY Minutes Per Week of Self-reported Physical Activity |
177.6; 143.1 | — |
| SECONDARY Self-reported Sleep Duration |
6.6; 6.5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03288142). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.