The Smart Hypertension Control Study

NCT03288142 | Completed Results DMC

• 1 other identifier: STU00205025
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Blood Pressure at 6 Months

  6 months

• Blood Pressure <140/90mmHg

  6 months

Secondary Outcomes (10)

• Number of Antihypertensive Agents Used

  6 months

• Antihypertensive Medication Intensification, No. of Additions, Dose Increases, or Substitutions

  6 months

• Number of Health System Contacts (Telephone, Office, or Mychart Encounters)

  6 months

• Frequency of Home Blood Pressure Measurements Per Month

  6 months

• Months When a Home Blood Pressure Reading is Obtained, No.

  6 months

Study Arms (2)

Intervention: Hypertension Coaching Application and Home Monitor:

EXPERIMENTAL

The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) ("Lark HTN Pro"), which is a smartphone application. 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. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.

Other: Hypertension Coaching Application and Home Monitor

Control:Tracking Application and Home Monitor:

ACTIVE COMPARATOR

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.

Other: Control: Tracking Application and Home Monitor

Interventions

Hypertension Coaching Application and Home Monitor OTHER

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

Also known as: Lark HTN Pro

Intervention: Hypertension Coaching Application and Home Monitor:

Control: Tracking Application and Home Monitor OTHER

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.

Control:Tracking Application and Home Monitor:

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Northwestern University: lead
• Omron Healthcare Co., Ltd.: collaborator

Study Sites (1)

Northwestern Medical Group

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Persell SD, Peprah YA, Lipiszko D, Lee JY, Li JJ, Ciolino JD, Karmali KN, Sato H. Effect of Home Blood Pressure Monitoring via a Smartphone Hypertension Coaching Application or Tracking Application on Adults With Uncontrolled Hypertension: A Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e200255. doi: 10.1001/jamanetworkopen.2020.0255.

  PMID: 32119093 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Stephen D. Persell, MD, MPH, FACP
• Organization: Northwestern University Feinberg School of Medicine

spersell@nm.org

312-503-6464

Study Officials

• Stephen D Persell, MD/MPH

  Northwestern Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Randomized controlled trial with randomization stratified by age and baseline systolic blood pressure.

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 19, 2017
• Study Start: September 21, 2017
• Primary Completion: April 28, 2019
• Study Completion: December 1, 2019
• Last Updated: April 15, 2022
• Results First Posted: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)