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Digital Intervention

Virtual Care for Heart Failure

N/A

Waitlist Available

Led By Adam DeVore, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >18 years of age

Be older than 18 years old

Must not have

Chronic use of intravenous inotropic medications including milrinone, dobutamine, or dopamine

Currently receiving hospice care

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess a digital intervention to help clinicians adjust heart failure meds, compared to usual care, to see if it's safe & effective.

Who is the study for?

This trial is for adults over 18 with heart failure and reduced ejection fraction (LVEF <40%) who have access to a smartphone. It's not for those in hospice care, pregnant, on certain heart failure therapies deemed optimal by the investigator, living in assisted facilities, using chronic IV heart medications, with prior heart transplants or severe kidney issues.

What is being tested?

The VITAL-HF study tests a digital intervention that helps doctors adjust heart failure medications remotely against usual care methods. The goal is to see if this virtual approach can safely improve outcomes for patients with reduced ejection fraction.

What are the potential side effects?

Since this trial involves medication management rather than new drugs, side effects may be related to changes in existing medication regimens. These could include typical heart failure medication side effects like blood pressure changes, kidney function alterations, or electrolyte imbalances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

Exclusion Criteria

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

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I regularly use medications like milrinone, dobutamine, or dopamine through an IV.

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I am currently in hospice care.

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I live in a facility where my food and medicine are managed by staff.

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My kidney function is very low or I am on long-term dialysis.

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I have a terminal illness with less than 1 year to live, not including heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in medical therapy, as measured by the Heart Failure Medical Therapy Score

Secondary study objectives

Change in medical therapy, as measured by the Kansas City Medical Optimization score

Combined Emergency department visits and hospitalizations, as measured by number of subjects with at least one occurrence

Intensification of evidence-based medical therapies, measured by number of participants with reported changes.

+2 more

Other study objectives

Cardiomyopathies

Change in participant-reported medication adherence using the Voils score

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Digital Heart Failure Medication TitrationExperimental Treatment1 Intervention

The Story Health platform will remotely receive daily vital signs directly from a blood pressure cuff and scale provided to the participant. Participants will also report any symptoms. All of this data will be transmitted, via the platform, to the treating clinician at the site, who will create care plans for medication titration and make clinical decisions. The care plans will be implemented with assistance from health coaches from Story Health Inc.

Group II: Usual CareActive Control1 Intervention

Routine clinical care will be followed. Participants will also receive a blood pressure cuff and scale, though the data will not be routinely fed back to the treating clinicians unless requested.

0 / 6Eligibility criteria met