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Trial record 18 of 660 for:    applied AND web-

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

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ClinicalTrials.gov Identifier: NCT03116815
Recruitment Status : Active, not recruiting
First Posted : April 17, 2017
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Holly J. Mattix-Kramer, Loyola University

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.

Condition or disease Intervention/treatment Phase
Hypertension Other: Direct input of home blood pressure readings via MyChart Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Other
Official Title: The Feasibility of a Web-based Application to Monitor Home Blood Pressure
Actual Study Start Date : May 16, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Intervention
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
Participants will record home blood pressure readings directly into the electronic health record via the MyChart application




Primary Outcome Measures :
  1. The total number of patients screened for the study [ Time Frame: 30 days ]
    The total number of patients who were examined for study eligibility

  2. The total number of patients who meet study eligibility [ Time Frame: 30 days ]
    The total number of patients who are screened for the study and meet study eligibility

  3. The total number of patients who provide written informed consent to participate in the study [ Time Frame: 30 days ]
    The total number of patients who enroll in the study and provide written informed consent

  4. The number of home blood pressure readings submitted by patients to the MyChart web-based application [ Time Frame: 60 days ]
    The actual number of home blood pressure readings that are recorded in the electronic health record as submitted via MyChart

  5. Change in systolic blood pressure [ Time Frame: 60 days ]
    Change in systolic blood pressure

  6. Change in diastolic blood pressure [ Time Frame: 60 days ]
    Change in diastolic blood pressure

  7. Physician actions based on home blood pressure readings [ Time Frame: 60 days ]
    Total number of times a physician escalates or de-escalates blood pressure lowering medications for a study participant

  8. Correlation between office and home blood pressure readings [ Time Frame: one day ]
    Correlation between the office blood pressure measurement using the clinic Omron machine and the patient's home blood pressure cuff

  9. Adverse events [ Time Frame: 60 days ]
    Total number of patient reported adverse events and all hospitalizations and emergency room visits

  10. Patient reported outcomes [ Time Frame: 60 days ]
    The percentage quality of life questionnaires completed by the study participants



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03116815


Locations
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United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Investigators
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Principal Investigator: Holly Kramer, MD MPH Loyola University Chicago

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Responsible Party: Holly J. Mattix-Kramer, Associate Professor, Loyola University
ClinicalTrials.gov Identifier: NCT03116815     History of Changes
Other Study ID Numbers: 209116
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Holly J. Mattix-Kramer, Loyola University:
blood pressure
monitoring
hypertension
patient reported outcomes

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases