ClinicalTrials.gov
ClinicalTrials.gov Menu

The Smart Hypertension Control Study (iSmartHyp)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03288142
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : September 27, 2017
Sponsor:
Collaborator:
Omron Healthcare Co., Ltd.
Information provided by (Responsible Party):
Stephen Persell, MD, MPH, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Hypertension Other: Lark HTN Pro Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial with randomization stratified by age and baseline systolic blood pressure.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Improving Hypertension Using a Smartphone-Enabled Personal Control Program: The Smart Hypertension Control Study
Actual Study Start Date : September 21, 2017
Estimated Primary Completion Date : September 18, 2018
Estimated Study Completion Date : June 28, 2019

Arm Intervention/treatment
Experimental: Intervention
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: Lark HTN Pro
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

No Intervention: Control
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.



Primary Outcome Measures :
  1. Systolic blood pressure (mmHg) at 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Diastolic blood pressure (mmHg) at 6 months [ Time Frame: 6 months ]
  2. Proportion with controlled blood pressure at 6 months (defined as BP <140/<90 mmHg) [ Time Frame: 6 months ]
  3. Medication adherence, measured as 4-day recall of antihypertensive medications [ Time Frame: 6 months ]
  4. Number of antihypertensive agents used at 6 months [ Time Frame: 6 months ]
  5. Number of antihypertensive medication changes (increases or substitution) [ Time Frame: 6 months ]
  6. Number of health system contacts (telephone, office, or mychart encounters) [ Time Frame: 6 months ]
  7. Frequency of home blood pressure measurements per month [ Time Frame: 6 months ]
  8. Proportion of months where a home blood pressure reading is obtained [ Time Frame: 6 months ]
  9. Self-efficacy to monitor and control high blood pressure [ Time Frame: 6 months ]
  10. Weight [ Time Frame: 6 months ]
  11. Diet quality score (as assessed by Dietary Approaches to Stop Hypertension questionnaire, DASH-Q [ Time Frame: 6 months ]
  12. Self-reported physical activity [ Time Frame: 6 months ]
  13. Self-reported sleep duration [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288142


Contacts
Contact: Stephen D Persell, MD/MPH 312-503-6464 spersell@nm.org
Contact: Yaw A Peprah, MPH 3125032753 yaw.peprah@northwestern.edu

Locations
United States, Illinois
Northwestern Medical Group Recruiting
Chicago, Illinois, United States, 60611
Contact: Northwestern Medical    312-926-2000      
Sponsors and Collaborators
Northwestern University
Omron Healthcare Co., Ltd.

Responsible Party: Stephen Persell, MD, MPH, Associate Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT03288142     History of Changes
Other Study ID Numbers: STU00205025
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases