Symptom Care at Home for Heart Failure

(SCH-HF Trial)

Recruiting at 4 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

81 Participants Needed

Trial Summary

What is the purpose of this trial?

This project aims to adapt a computer-interface telephonic interactive voice response system that monitors symptoms and provides real-time, self-management coaching messages based on heart failure patient-reported outcomes.

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 data supports the effectiveness of the treatment Symptom Care at Home-Heart Failure?

Research shows that home-based disease management programs for heart failure patients can improve quality of life by addressing common and distressing symptoms. Additionally, using patient-reported outcome tools in heart failure clinics can enhance symptom monitoring and improve patient outcomes. ^{1 2 3 4 5}

Is the Symptom Care at Home for Heart Failure treatment safe for humans?

The research articles provided do not contain specific safety data for the Symptom Care at Home for Heart Failure treatment or similar interventions. ^{1 4 6 7 8}

How is the Symptom Care at Home-Heart Failure treatment different from other heart failure treatments?

The Symptom Care at Home-Heart Failure treatment is unique because it focuses on managing symptoms at home, using patient-reported outcomes to improve quality of life, rather than just reducing hospitalizations or mortality. This approach emphasizes self-care and home-based management, which can be particularly beneficial for older adults who can manage their own health care needs. ^{1 2 4 9 10}

Research Team

Youjeong Kang, PhD

Principal Investigator

Emory University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Prioritizing symptom management in the treatment of chronic heart failure. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

Approach to advanced heart failure at the end of life. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Heart failure clinic in a community hospital improves outcome in heart failure patients. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Symptom status and quality-of-life outcomes of home-based disease management program for heart failure patients. [2019]

5. England pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

A comprehensive symptom diary intervention to improve outcomes in patients with HF: a pilot study. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Signs, symptoms, and treatment patterns across serial ambulatory cardiology visits in patients with heart failure: insights from the NCDR PINNACLE® registry. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Event-free survival in adults with heart failure who engage in self-care management. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Challenges and strategies for heart failure symptom management in older adults. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Association of the induction of a self-care management system with 1-year outcomes in patients hospitalized for heart failure. [2021]