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

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Direct input of home blood pressure readings via MyChart
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension focused on measuring blood pressure, monitoring, hypertension, patient reported outcomes

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers
  • Inclusion Criteria:

    • 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
  • Exclusion Criteria:

    • 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

Sites / Locations

  • Loyola University Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

The total number of patients screened for the study
The total number of patients who were examined for study eligibility
The total number of patients who meet study eligibility
The total number of patients who are screened for the study and meet study eligibility
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
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
Change in systolic blood pressure
Change in systolic blood pressure
Change in diastolic blood pressure
Change in diastolic blood pressure
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
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
Adverse events
Total number of patient reported adverse events and all hospitalizations and emergency room visits
Patient reported outcomes
The percentage quality of life questionnaires completed by the study participants

Secondary Outcome Measures

Full Information

First Posted
April 11, 2017
Last Updated
March 4, 2020
Sponsor
Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT03116815
Brief Title
The Feasibility of a Web-based Application to Monitor Home Blood Pressure
Official Title
The Feasibility of a Web-based Application to Monitor Home Blood Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 16, 2017 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Observational studies and clinical trials have demonstrated that clinicians fail to intensify therapy in hypertensive management despite patients not meeting goal. For this reason, patient centered tools can help facilitate meeting goals with the provider. Web-based communication combined with provider care management successfully lowered blood pressure to <140/90 mm Hg in prior studies of patients with hypertension. Emerging technology now provides the ability for patients to upload self-measured home blood pressure information into their own medical record which may eliminate the need for additional health personnel. This study will investigate the feasibility of health informatics to facilitate better compliance and safety for both provider and patient for hypertension management. The home blood pressure readings along with patient reported symptoms will be recorded using the MyChart, a web-based tool available to all patients receiving care at Loyola University Medical Center. MyChart can be accessed with a hand-held device or home computer. After enrollment, patients will receive a notice every two weeks via MyChart to upload home blood pressure values and patient reported symptoms. This information entered into MyChart by patients will be placed into the electronic health record in a home vital signs flow sheet, which will be separate from the flow sheet of vital signs measured in the clinic. Physicians will receive an alert message when patients upload the blood pressure data. The alert message will provide physicians with the average blood pressure value over the two weeks and will provide simple guidance on whether actions, such as titrating existing medication should be taken (based on whether BP is ≥ 140/90 mmHg). Patients will also be able to track their own home blood pressure values using the MyChart application. As a first step, we are first examining the feasibility of this web-based application and determining the perceptions of both patients and physicians.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
blood pressure, monitoring, hypertension, patient reported outcomes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Direct input of home blood pressure readings via MyChart
Intervention Description
Participants will record home blood pressure readings directly into the electronic health record via the MyChart application
Primary Outcome Measure Information:
Title
The total number of patients screened for the study
Description
The total number of patients who were examined for study eligibility
Time Frame
30 days
Title
The total number of patients who meet study eligibility
Description
The total number of patients who are screened for the study and meet study eligibility
Time Frame
30 days
Title
The total number of patients who provide written informed consent to participate in the study
Description
The total number of patients who enroll in the study and provide written informed consent
Time Frame
30 days
Title
The number of home blood pressure readings submitted by patients to the MyChart web-based application
Description
The actual number of home blood pressure readings that are recorded in the electronic health record as submitted via MyChart
Time Frame
60 days
Title
Change in systolic blood pressure
Description
Change in systolic blood pressure
Time Frame
60 days
Title
Change in diastolic blood pressure
Description
Change in diastolic blood pressure
Time Frame
60 days
Title
Physician actions based on home blood pressure readings
Description
Total number of times a physician escalates or de-escalates blood pressure lowering medications for a study participant
Time Frame
60 days
Title
Correlation between office and home blood pressure readings
Description
Correlation between the office blood pressure measurement using the clinic Omron machine and the patient's home blood pressure cuff
Time Frame
one day
Title
Adverse events
Description
Total number of patient reported adverse events and all hospitalizations and emergency room visits
Time Frame
60 days
Title
Patient reported outcomes
Description
The percentage quality of life questionnaires completed by the study participants
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly Kramer, MD MPH
Organizational Affiliation
Loyola University Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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