The Feasibility of a Web-based Application to Monitor Home Blood Pressure

NCT03116815 | Completed

• 1 other identifier: 209116
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Control of hypertension remains one of the most important interventions available to clinicians to reduce risk of cardiovascular disease, kidney disease and stroke. Self-measured home blood pressure monitoring plus additional support has been shown to reduce blood pressure in adults with previously uncontrolled hypertension. Most previous studies have utilized healthcare personnel to facilitate communication of home blood pressure levels to physicians and did not provide methods to directly transmit self-measured blood home blood pressure levels to physicians via the electronic health record. Emerging technology now provides the ability for patient's to upload self-measured blood pressure levels into their own medical record which may eliminate the need for additional health personnel. This study will examine the feasibility, patient adherence and physician and patient perceptions of a web-based application which will facilitate direct input of self-measured home blood pressure levels and patient reported symptoms directly into the electronic health record with message alerts to the provider for hypertension management. Up to 10 Loyola primary care physicians and 20 of their respective patients age 50 years and older who have a smart phone device or home computer and have treated hypertension will be enrolled. The study will utilize the existing web-application called MyChart. MyChart is the name of the web-based application and it is not an acronym. Enrolled patients will download the existing MyChart web-based application on their smart phone device or home computer and will record home blood pressure measurements using their home blood pressure machine into their smart phone application. The MyChart application is available to all patients receiving care in the Loyola Health Care System. The blood pressure readings and patient reported symptoms will then be available for their physicians to review within the electronic health record. After using the web-based application for two months, both patients and physicians will be asked to participate in focus groups and interviews, respectively, to determine their perceptions and satisfaction with the web-based application. Data from this feasibility study may be used to guide a future clinical trial of hypertension management that examines the effectiveness of the MyChart web-based application for frequent blood pressure monitoring compared to standard care.

Conditions

Hypertension

Keywords

blood pressure; monitoring; hypertension; patient reported outcomes

Outcome Measures

Primary Outcomes (10)

• The total number of patients screened for the study

  The total number of patients who were examined for study eligibility

  30 days

• The total number of patients who meet study eligibility

  The total number of patients who are screened for the study and meet study eligibility

  30 days

• The total number of patients who provide written informed consent to participate in the study

  The total number of patients who enroll in the study and provide written informed consent

  30 days

• The number of home blood pressure readings submitted by patients to the MyChart web-based application

  The actual number of home blood pressure readings that are recorded in the electronic health record as submitted via MyChart

  60 days

• Change in systolic blood pressure

  Change in systolic blood pressure

  60 days

• Change in diastolic blood pressure

  Change in diastolic blood pressure

  60 days

• Physician actions based on home blood pressure readings

  Total number of times a physician escalates or de-escalates blood pressure lowering medications for a study participant

  60 days

• Correlation between office and home blood pressure readings

  Correlation between the office blood pressure measurement using the clinic Omron machine and the patient's home blood pressure cuff

  one day

• Adverse events

  Total number of patient reported adverse events and all hospitalizations and emergency room visits

  60 days

• Patient reported outcomes

  The percentage quality of life questionnaires completed by the study participants

  60 days

Study Arms (1)

Intervention

OTHER

Intervention is the use of the MyChart web-application whereby participants record their home blood pressure readings directly into their electronic medical record. Their physicians are then alerted of these blood pressure readings.

Other: Direct input of home blood pressure readings via MyChart

Interventions

Direct input of home blood pressure readings via MyChart OTHER

Participants will record home blood pressure readings directly into the electronic health record via the MyChart application

Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to participate in all study procedures
• Potential subject owns a personal device and is able to run the web-application
• Physician directed blood pressure goal is \< 140/90 mmHg

You may not qualify if:

• No use of blood pressure lowering medications
• Arm circumference too large or small to allow accurate blood pressure measurement
• A medical condition likely to limit survival to less than 6 months, or a cancer diagnosed and treated within the past two years that, in the judgment of clinical study staff, would compromise a participant's ability to complete the study
• Inability to give informed consent
• History of systolic heart failure (ejection fraction \< 35%)
• History of stroke
• History of proteinuria ≥ 1 gram in a 24 hour urine collection or a random urine albumin/creatinine ratio ≥ 300 mg/g or a random urine protein/creatinine ratio ≥ 300 mg/g

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Holly Kramer, MD MPH

  Loyola University Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This single arm study will examine use of the MyChart web-application whereby patients directly record their home blood pressure readings into their electronic health record with this web-based application.

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 17, 2017
• Study Start: May 16, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: March 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)