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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

Must not have

Patient weight > 385 lbs at time of enrollment

Hospice or palliative care

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 6 months (final)

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I weigh more than 385 lbs.

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I am currently receiving hospice or palliative care.

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I am on long-term dialysis for kidney failure.

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I am currently receiving treatment for cancer.

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I do not have any major surgeries planned in the next 6 months.

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I live in a care facility but can move around on my own.

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I am not pregnant nor planning to become pregnant in the next 6 months.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 6 months (final) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Myia Platform feasibility: questionnaire

Secondary study objectives

Medication management: length of time to medication change

Pharmaceutical Preparations

Medication management: total number of medication changes

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

0 / 10Eligibility criteria met