Symptom Care at Home for Heart Failure

(SCH-HF Trial)

Recruiting at 3 trial locations

Overseen By Youjeong Kang, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Hospice care, End-stage renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people with heart failure manage symptoms at home. It uses a phone-based system that checks in with patients daily and provides personalized coaching based on their reported symptoms. This approach, called Symptom Care at Home-Heart Failure, involves two groups: one receives both monitoring and coaching messages, while the other gets monitoring only. It suits those diagnosed with heart failure who have access to a phone and are comfortable communicating in English. As an unphased trial, this study offers a unique opportunity to contribute to innovative heart failure management strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this telephonic interactive voice response system is safe for heart failure patients?

Research has shown that home monitoring systems for heart failure, such as the Symptom Care at Home program, are generally safe. One study found that patients using a similar home program experienced fewer problems than those receiving standard care. Specifically, only 12.5% of patients in the home program had issues, compared to 35% in the standard care group. This suggests that the system is well-tolerated and might even lower the risk of complications. Additionally, telemedicine (remote care with technology) has reduced hospital readmissions by nearly 50%, indicating its effectiveness and safety. These findings suggest that the Symptom Care at Home program could be a safe option for managing heart failure at home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel way to manage heart failure symptoms at home. Unlike traditional treatments that often require frequent clinic visits, this approach integrates automated daily monitoring with real-time self-management coaching, empowering patients to actively manage their condition. This method not only aims to improve patient engagement and adherence but also has the potential to enhance quality of life by providing immediate feedback and personalized guidance. By leveraging technology, this trial could offer a more convenient and responsive care model for individuals with heart failure.

What evidence suggests that this trial's treatments could be effective for heart failure?

Research has shown that self-care at home is crucial for managing heart failure. In this trial, participants in the "Symptom Care at Home with Coaching Messages" arm will receive automated daily monitoring and real-time self-management coaching. Studies have found that such programs can lower the risk of complications by providing real-time advice based on symptoms. Specifically, one study showed that patients experienced fewer problems (12.5% compared to 35%) when they received help managing their symptoms. This approach helps patients remain at home with fewer symptoms after hospital discharge. Early results suggest this system could improve heart failure management by encouraging patients to take charge of their health. ^{1 2 3 5 6}

Who Is on the Research Team?

Youjeong Kang, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for heart failure patients who can manage at home without extra care, speak English, and have daily phone access. They should be NYHA class II or III, indicating some physical activity limitation due to heart failure. Participants must have a history of hospital readmission and take diuretics regularly.

Inclusion Criteria

I take water pills every day.

Have daily access to any type of telephone

My heart condition limits my physical activity slightly to markedly.

Exclusion Criteria

I am receiving hospice care at home.

I do not have end-stage renal failure requiring frequent dialysis.

I may have memory or thinking problems based on a simple test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive automated daily monitoring and real-time self-management coaching or usual care

4 weeks

Daily monitoring (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Symptom Care at Home-Heart Failure

Trial Overview

The study tests a telephonic system that tracks symptoms and gives self-management advice to heart failure patients based on their reported conditions. The goal is to see if this technology helps improve patient outcomes by promoting better self-care practices.

How Is the Trial Designed?

Group I: Symptom Care at Home with Coaching Messages Experimental Treatment 2 Interventions

Participants randomized to automated daily monitoring and real-time self-management coaching.

Group II: Usual Care Active Control 1 Intervention

Participants randomized to automated daily monitoring only.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The TIM-HF2 trial, involving 1571 heart failure patients, demonstrated that remote patient management significantly reduced the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause death compared to usual care, with a reduction from 6.64% to 4.88%.

Patients receiving remote management had a lower all-cause death rate of 7.86 per 100 person-years compared to 11.34 per 100 person-years in the usual care group, indicating that this intervention may enhance patient outcomes in heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial. Koehler, F., Koehler, K., Deckwart, O., et al.[2022]

Patients managed in a heart failure clinic had a significantly lower rate of rehospitalization or death (42%) compared to those receiving usual care (65%) over a follow-up period of about 561 days, indicating better outcomes with specialized management.

Those in the heart failure clinic not only received more optimal pharmacological therapy but also reported a better quality of life, highlighting the benefits of targeted care in managing heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart failure clinic in a community hospital improves outcome in heart failure patients. Lainscak, M., Keber, I.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04347759

NCT04347759 | Symptom Care at Home-Heart Failure

This project aims to adapt a computer-interface telephonic interactive voice response system that monitors symptoms and provides real-time, self-management ...

2.

trialx.com

trialx.com/clinical-trials/listings/262710/symptom-care-at-home-heart-failure-pilot-study/?&radius=50

Symptom Care at Home Heart Failure Pilot Study

Keeping heart failure (HF) patients at home with a low symptom burden after hospital discharge is challenging. Evidence shows that delay in HF ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10711907/

Heart failure management at home: a non-randomised ...

Primary outcomes demonstrated that HAH patients had slightly longer LOS (6.3 days vs 4.7 days); however, fewer adverse events (12.5% vs 35%) ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11908091/

The effectiveness of nursing interventions to improve self-care ...

Self-care plays an important role in the treatment of patients with heart failure (HF) and adequately performed self-care at home can ...

5.

cardio.jmir.org

cardio.jmir.org/2025/1/e64877

Evaluation of a Virtual Home Health Heart Failure Program

This study aimed to evaluate the clinical and behavioral outcomes of patients undertaking a Virtual Home Health Heart Failure Program (VHHHFP) ...

6.

jacc.org

jacc.org/doi/10.1016/j.jacc.2023.04.010

Remote Monitoring for Heart Failure Management at Home

Xu et al found that the risk for 30-day or 90-day readmission was decreased by almost 50% by either telemedicine or in-person follow-up visit ...