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Can a 10-Week coaching program ease the toll on heart failure caregivers?

NCT ID NCT07805811

Symptom relief Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests a program called HEROIC, designed to support people caring for someone with advanced heart failure. Caregivers receive five one-on-one video sessions with a nurse over 10 weeks, focusing on mental health, self-care, and connecting with community and palliative resources. The study includes 500 caregiver-patient pairs and measures whether the program improves caregivers' mental well-being, patients' quality of life, and reduces unplanned hospital visits. It also looks at how the program works for different heart failure groups, such as those with a ventricular assist device or a heart transplant.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HEROIC program, a nurse-led behavioral intervention with 5 video sessions over 10 weeks to support caregivers of heart failure patients
What this could lead to
If it works, this program could offer a practical way to improve caregivers' mental health and reduce unplanned hospital visits for heart failure patients.
What could go wrong
This is a phase 2 trial, so results are uncertain. The program may not improve outcomes for all caregivers or patient groups, and it requires time and commitment from participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Caregiver Inclusion Criteria: * English or Spanish-speaking. * \> 18 years old. * Supports at least one activity of daily living (ADL) or instrumental activity of daily living IADL) for the person with HF (care recipient). * Lives with the person with HF or visits regularly (e.g. weekly phone calls and visits at least once per month) to provide ADL/IADL support. * ≥5 on the Zarit Burden Interview Patient Inclusion Criteria: * English or Spanish-speaking. * \> 18 years old. * Reports needing help with at least one activity of daily living or instrumental activity of daily living. * Identifies a primary caregiver AND caregiver consents. * Diagnosed with heart failure. AND 1. If Medically managed, no Ventricular Assist Device (VAD) or Transplant (TX): Documentation of HF with preserved ejection fraction OR HF with reduced ejection fraction (LVEF\<40%) OR Documented American College of Cardiology / American Heart Association (ACC/AHA) HF stage C or D (EMR) OR Documentation of New York Heart Association functional class II - IV (EMR) 2. If ventricular assist device: \> 1 month since implant AND ambulatory/outpatient 3. If heart transplant: \> 1 month since Heart Transplant (HTx) AND ambulatory/outpatient Exclusion Criteria: * Patients and caregivers who screen positive for severe cognitive impairment Telephone Interview for Cognitive Screening (TICS-M) will be excluded.

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Caregiver Heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Johns Hopkins University, School of Nursing

    Baltimore, Maryland, 21205, United States

  • University of Colorado Anschutz

    Denver, Colorado, 80217, United States

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