Virtual Care for Heart Failure

(VICTORY-HF Trial)

Recruiting at 8 trial locations

Overseen By VICTORY-HF Project office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Population Health Research Institute

Disqualifiers: Severe lung disease, Severe kidney disease, Active malignancy, others

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

Compensation: Varies

Number of Visits: 90

Duration: 90 days

891 Participants Needed

Trial Summary

What is the purpose of this trial?

The clinic visits (intervention) will continue for 90 days, which represents the follow-up period for the primary medication and health status outcomes. The co-primary clinical outcomes will be obtained at 180 days.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Routine HF Care, Virtual HF Care for heart failure?

Research shows that virtual healthcare solutions, including remote patient management, can significantly reduce hospital readmissions and improve self-care in heart failure patients. The TIM-HF2 trial demonstrated that remote patient management reduced all-cause mortality and hospitalizations compared to usual care. ^{1 2 3 4 5}

Is virtual care for heart failure safe for humans?

The research on virtual care for heart failure, which includes remote monitoring and digital health solutions, does not specifically mention safety concerns, suggesting it is generally considered safe for human use. ^{4 6 7 8 9}

How does the Virtual HF Care treatment differ from other heart failure treatments?

Virtual HF Care is unique because it uses mobile technologies and virtual visits to provide remote monitoring and real-time communication between patients and healthcare providers, which can help reduce hospital readmissions and improve patient self-care. This approach is particularly beneficial for older, frail, or homebound patients who face challenges accessing traditional in-person care. ^{2 3 4 7 10}

Research Team

Harriette Van Spall, MD

Principal Investigator

McMaster University

Eligibility Criteria

This trial is for adults over 18 with heart failure, recently hospitalized or seen urgently for the condition. Participants must have NT-proBNP >900 pg/ml and LVEF <55% within the last 3 months. They should be able to use virtual care tools (with help if needed) and provide a mailing address.

Inclusion Criteria

provide consent.

have a mailing address for the patient or caregiver

are competent (either independently or with caregiver) in using the virtual care platform during a brief demonstration

Timeline

Pilot Phase

Pilot phase conducted to assess the acceptability and feasibility of the intervention, refine the virtual delivery process, and finalize protocols

Not specified

Treatment

Participants receive virtual HF care to optimize medical therapies

90 days

Number of virtual and in-person clinic visits per patient in 90 days

Follow-up

Participants are monitored for primary medication and health status outcomes

90 days

Extended Follow-up

Co-primary clinical outcomes obtained, including all-cause death, HF hospitalization, and ED visits

180 days

Treatment Details

Interventions

• Routine HF Care
• Virtual HF Care

Trial Overview The study compares two types of post-hospitalization heart failure care: Virtual HF Care versus Routine HF Care. It examines how these approaches affect medication adherence and health status over a follow-up period of 90 days, with clinical outcomes assessed at 180 days.

Participant Groups

Group I: Virtual HF care Experimental Treatment 1 Intervention

Patients will receive virtual HF care to optimize medical therapies

Group II: Routine HF care Experimental Treatment 1 Intervention

Participants will receive routine HF care

Who Is Running the Clinical Trial?

Population Health Research Institute

Lead Sponsor

Trials

165

Recruited

717,000+

Hamilton Health Sciences Corporation

Collaborator

Trials

380

Recruited

345,000+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Findings from Research

In the TIM-HF2 trial involving 1,538 heart failure patients, remote patient management (RPM) showed a significant reduction in all-cause mortality for patients with an estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 m², with a 1-year survival rate of 89.4% compared to 84.6% in usual care (UC).

RPM also led to lower rates of heart failure hospitalizations and all-cause death in both eGFR subgroups, indicating its potential effectiveness in managing heart failure, particularly in patients with compromised kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Patient Management May Reduce All-Cause Mortality in Patients With Heart-Failure and Renal Impairment. Naik, MG., Budde, K., Koehler, K., et al.[2022]

A study involving 49 homebound, frail, and older patients with heart failure showed that nurse-assisted virtual video visits significantly reduced hospitalization rates and days compared to the previous year, indicating improved management of heart failure in this population.

The model demonstrated a decrease in emergency department visits, suggesting that virtual care can effectively address the barriers faced by older patients in accessing specialized cardiac care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Frail and Older Homebound Patients With Heart Failure: A Contemporary Virtual Ambulatory Model. Kobulnik, J., Wang, IY., Bell, C., et al.[2022]

The LEAP Virtual Visit protocol for heart failure patients outlines a structured approach to virtual healthcare, detailing specific steps, roles, and tools needed for effective implementation, which can enhance patient care.

This protocol includes comprehensive support materials for both clinicians and patients, aiming to improve satisfaction and streamline the virtual visit process, potentially benefiting the overall healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LEAP Virtual Visit Assessment (VIVA): a structured protocol for virtual visits for patients with heart failure. Gori, M., Bonmassari, R., Correale, M., et al.[2022]

Mobile technologies for post-discharge care in heart failure patients can significantly improve remote patient management, particularly in reducing rehospitalization rates, as shown in a review of 171 studies.

The most effective interventions focus on patient self-care and managing all-cause hospital visits, with integrated remote patient management solutions demonstrating the best outcomes in decreasing readmission rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual healthcare solutions in heart failure: a literature review. Lee, KC., Breznen, B., Ukhova, A., et al.[2023]

Remote patient management (RPM) significantly improved heart failure-specific self-care behaviors in patients, with an increase in self-care scores from 78.7 to 84.5 in the RPM group compared to a smaller increase in the usual care group, indicating better adherence to heart failure regimens.

The most notable improvements in self-care were observed in patients living alone and those with initially low self-care scores, suggesting that RPM can be particularly beneficial for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of remote patient management on self-care behaviour in heart failure patients: results from the randomized TIM-HF2 trial. Deckwart, O., Koehler, K., Lezius, S., et al.[2023]

A digital solution called SK-141 was found to be highly acceptable among heart failure patients, with an 80% retention rate over an 8-week study involving 20 participants, indicating strong patient engagement.

Clinical outcomes showed promising trends towards improvement, suggesting that remote monitoring and self-care support could enhance the quality of life for heart failure patients, warranting further research in a larger, controlled study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving outpatient care for heart failure through digital innovation: a feasibility study. Arnar, DO., Oddsson, SJ., Gunnarsdottir, T., et al.[2022]

A pilot study involving 28 heart failure patients tested a web-based self-care intervention, showing small improvements in self-care (d=0.32) and self-efficacy (d=0.37) after one month, but minimal change in heart failure knowledge (d=0.06).

Despite the intervention's potential, only 50% of participants accessed the web platform daily, indicating challenges in engagement that need to be addressed in larger trials to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a Web-Based Self-Management Intervention in Heart Failure Patients: A Pilot Study. Bashi, N., Windsor, C., Douglas, C.[2020]

In a survey of 125 heart failure patients, over half (52%) expressed disinterest in using digital health solutions for follow-up, highlighting challenges in implementing digital patient-reported outcome measures (PROMs) in this population.

Among those willing to use digital solutions, a web-based option was preferred by 70%, indicating a potential direction for future digital health interventions, especially considering that older patients were less likely to engage with digital tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' preferences regarding the digital capturing of patient-reported outcomes: planning the future follow-up in a prospective heart failure registry. König, S., Leiner, J., Nitsche, A., et al.[2023]

Digital health interventions (DHI) significantly reduced all-cause mortality (8.5% vs. 10.2%) and cardiovascular mortality (7.3% vs. 9.6%) in patients with a history of heart failure hospitalization, based on a review of 10 trials involving 7204 patients over an average follow-up of 15.6 months.

While DHI did not significantly decrease overall hospitalizations for heart failure or all causes, patients using DHI experienced fewer days lost due to heart failure-related hospitalizations, indicating a potential benefit in managing heart failure symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital health intervention in patients with recent hospitalization for acute heart failure: A systematic review and meta-analysis of randomized trials. Elbadawi, A., Tan, BE., Assaf, Y., et al.[2022]

Heart failure (HF) is becoming increasingly prevalent, especially among older adults, and the current treatment methods are not effectively tailored to individual patient needs, highlighting the need for a new approach.

The proposed solution involves a predictive, preventive, and personalized medicine strategy using an AI-driven online application that empowers patients to manage their own care, potentially improving outcomes and reducing healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artificial intelligence supported patient self-care in chronic heart failure: a paradigm shift from reactive to predictive, preventive and personalised care. Barrett, M., Boyne, J., Brandts, J., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Remote Patient Management May Reduce All-Cause Mortality in Patients With Heart-Failure and Renal Impairment. [2022]

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

Management of Frail and Older Homebound Patients With Heart Failure: A Contemporary Virtual Ambulatory Model. [2022]

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

LEAP Virtual Visit Assessment (VIVA): a structured protocol for virtual visits for patients with heart failure. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual healthcare solutions in heart failure: a literature review. [2023]

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

Effects of remote patient management on self-care behaviour in heart failure patients: results from the randomized TIM-HF2 trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Improving outpatient care for heart failure through digital innovation: a feasibility study. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Evaluating a Web-Based Self-Management Intervention in Heart Failure Patients: A Pilot Study. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Patients' preferences regarding the digital capturing of patient-reported outcomes: planning the future follow-up in a prospective heart failure registry. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Digital health intervention in patients with recent hospitalization for acute heart failure: A systematic review and meta-analysis of randomized trials. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Artificial intelligence supported patient self-care in chronic heart failure: a paradigm shift from reactive to predictive, preventive and personalised care. [2020]