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Behavioural Intervention
Remote Patient Monitoring for Heart Failure
N/A
Waitlist Available
Led By Greg Ewald, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to ambulate
Age ≥ 18 years old at time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 6 months (final)
Awards & highlights
Study Summary
This trial will study whether using a remote patient monitoring system can help manage heart failure patients outside of a hospital setting.
Who is the study for?
Adults over 18 with heart failure, specifically reduced ejection fraction (HFrEF), who've been hospitalized for it in the past year. They must be patients at BJH Advanced Heart Failure Clinic and not planning major surgeries or pregnancies soon. Excludes those in long-term care facilities, with a life expectancy under a year, on dialysis, or undergoing cancer treatment.Check my eligibility
What is being tested?
The trial is testing Myia Health's remote monitoring system to see if it helps manage heart failure outside of the hospital. Participants will have their health passively monitored continuously and follow up with clinic visits.See study design
What are the potential side effects?
Since this study involves remote monitoring rather than medication, traditional side effects are not expected. However, there may be privacy concerns or discomfort from wearing monitoring devices.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk on my own.
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I am 18 years old or older.
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I have moderate to severe heart function issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 6 months (final)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 6 months (final)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Myia Platform feasibility: questionnaire
Secondary outcome measures
Medication management: length of time to medication change
Pharmaceutical Preparations
Medication management: total number of medication changes
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Remote patient monitoringExperimental Treatment1 Intervention
After consenting to the study, the Myia in-home suite of devices, and mobile phone application if the patient owns a smart phone, will be provided to all recruited patients. The data flowing from the Myia platform will be available to clinicians and patients for the duration of the pilot and utilized to complete study activities.
Patients enrolled will transmit daily vital sign data to the Myia Health remote patient monitoring platforms for clinical review.
Enrolled patients will complete medication change/compliance survey monthly to assess for medication changes.
Enrolled patients will complete symptomatic assessments (KCCQ-12) at 0, 3, and 6 months.
Enrolled patients will complete a Check-In survey to assess utility and usability of the intervention at the 2, 4, and 6 month timepoints
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,544 Total Patients Enrolled
18 Trials studying Heart Failure
77,908 Patients Enrolled for Heart Failure
Healthcare Innovation LabUNKNOWN
MYIA Labs, Inc.UNKNOWN
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Heart Failure
30 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh more than 385 lbs.You have been to the emergency room or hospitalized for heart failure in the year before joining the study.You are using a wearable device that could interfere with heart measurement tests.You are an outpatient receiving care from the BJH Advanced Heart Failure Clinic as your main cardiology care team.Sleeps in the same bed at least 4 days a week.I can walk on my own.I am currently receiving hospice or palliative care.You are not expected to live for more than one year.You have a heart pump or have had a heart transplant.You have been diagnosed with heart failure with reduced ejection fraction at the BJH Advanced Heart Failure Clinic.I am on long-term dialysis for kidney failure.I am currently receiving treatment for cancer.Your heart's pumping function, called LVEF, is too low.I am willing to complete all surveys and activities required by the study.I do not have any major surgeries planned in the next 6 months.I live in a care facility but can move around on my own.I am not pregnant nor planning to become pregnant in the next 6 months.I am 18 years old or older.You are currently waiting for a heart transplant.I have moderate to severe heart function issues.
Research Study Groups:
This trial has the following groups:- Group 1: Remote patient monitoring
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available openings in this experiment?
"The clinicaltrials.gov website attests that this study is not currently open for recruitment, despite the fact it was initially made available to participants on February 11th 2020 and last updated on April 11th 2022. Nonetheless, there are 701 other research projects actively recruiting patients at present."
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