Virtual Care for Heart Failure
(VICTORY-HF Trial)
Recruiting in Palo Alto (17 mi)
+8 other locations
Overseen byHarriette Van Spall, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Population Health Research Institute
Disqualifiers: Severe lung disease, Severe kidney disease, Active malignancy, others
No Placebo Group
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.12345
Is virtual care for heart failure safe for humans?
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.234710
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
See 3 more
Trial 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 (Behavioural Intervention)
- Virtual HF Care (Behavioural Intervention)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Group I: Virtual HF careExperimental Treatment1 Intervention
Patients will receive virtual HF care to optimize medical therapies
Group II: Routine HF careExperimental Treatment1 Intervention
Participants will receive routine HF care
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Thunder Bay Regional Health Sciences CentreThunder Bay, Canada
Unity Health TorontoToronto, Canada
Juravinski Hospital Cancer CentreHamilton, Canada
St. Joseph's Healthcare HamiltonHamilton, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Population Health Research InstituteLead Sponsor
Hamilton Health Sciences CorporationCollaborator
McMaster UniversityCollaborator
References
Remote Patient Management May Reduce All-Cause Mortality in Patients With Heart-Failure and Renal Impairment. [2022]Remote patient management (RPM) in heart failure (HF) patients has been investigated in several prospective randomized trials. The Telemedical Interventional Management in Heart Failure II (TIM-HF2)-trial showed reduced all-cause mortality and hospitalizations in heart failure (HF) patients using remote patient management (RPM) vs. usual care (UC). We report the trial's results for prespecified eGFR-subgroups.
Management of Frail and Older Homebound Patients With Heart Failure: A Contemporary Virtual Ambulatory Model. [2022]Heart failure (HF) affects many patients who are older and frail, presenting multiple physical barriers to accessing specialty care in a traditional ambulatory clinic model. Here, we present an assisted virtual care model in which a home visiting nurse facilitated video visits with a HF cardiologist to follow homebound, frail, and older patients with HF.
LEAP Virtual Visit Assessment (VIVA): a structured protocol for virtual visits for patients with heart failure. [2022]Telemedicine may be of benefit in patients with heart failure (HF), although virtual visits are often carried out on an ad hoc basis. Herein, we discuss a structured protocol that defines all the steps needed for virtual visits, LEAP Virtual Visit, which includes guides and support kits for clinicians and patients.
Virtual healthcare solutions in heart failure: a literature review. [2023]The widespread adoption of mobile technologies offers an opportunity for a new approach to post-discharge care for patients with heart failure (HF). By enabling non-invasive remote monitoring and two-way, real-time communication between the clinic and home-based patients, as well as a host of other capabilities, mobile technologies have a potential to significantly improve remote patient care. This literature review summarizes clinical evidence related to virtual healthcare (VHC), defined as a care team + connected devices + a digital solution in post-release care of patients with HF. Searches were conducted on Embase (06/12/2020). A total of 171 studies were included for data extraction and evidence synthesis: 96 studies related to VHC efficacy, and 75 studies related to AI in HF. In addition, 15 publications were included from the search on studies scaling up VHC solutions in HF within the real-world setting. The most successful VHC interventions, as measured by the number of reported significant results, were those targeting reduction in rehospitalization rates. In terms of relative success rate, the two most effective interventions targeted patient self-care and all-cause hospital visits in their primary endpoint. Among the three categories of VHC identified in this review (telemonitoring, remote patient management, and patient self-empowerment) the integrated approach in remote patient management solutions performs the best in decreasing HF patients' re-admission rates and overall hospital visits. Given the increased amount of data generated by VHC technologies, artificial intelligence (AI) is being investigated as a tool to aid decision making in the context of primary diagnostics, identifying disease phenotypes, and predicting treatment outcomes. Currently, most AI algorithms are developed using data gathered in clinic and only a few studies deploy AI in the context of VHC. Most successes have been reported in predicting HF outcomes. Since the field of VHC in HF is relatively new and still in flux, this is not a typical systematic review capturing all published studies within this domain. Although the standard methodology for this type of reviews was followed, the nature of this review is qualitative. The main objective was to summarize the most promising results and identify potential research directions.
Effects of remote patient management on self-care behaviour in heart failure patients: results from the randomized TIM-HF2 trial. [2023]Remote patient management (RPM) in heart failure (HF) patients has beneficial clinical effects. This analysis investigates the effects of RPM used in the Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial on HF-specific self-care.
Improving outpatient care for heart failure through digital innovation: a feasibility study. [2022]Heart failure (HF) affects over 26 million people worldwide. Multidisciplinary management strategies that include symptom monitoring and patient self-care support reduce HF hospitalization and mortality rates. Ideally, HF follow-up and self-care support includes lifestyle-change recommendations and remote monitoring of weight and HF symptoms. Providing these via a digital solution may be ideal for improving HF disease outcomes and reducing the burden on providers and healthcare systems. This study's main objective was to assess the feasibility of a digital solution including remote monitoring, lifestyle-change, and self-care support for HF outpatients in Iceland.
Evaluating a Web-Based Self-Management Intervention in Heart Failure Patients: A Pilot Study. [2020]Web-based interventions may have the potential to support self-care in patients with chronic disease, yet little is known about the feasibility of Web-based interventions in patients with heart failure (HF).
Patients' preferences regarding the digital capturing of patient-reported outcomes: planning the future follow-up in a prospective heart failure registry. [2023]Digital health technologies have the potential to improve patient care sustainably. A digital capturing of patient-reported outcome measures (PROMs) could facilitate patients' surveillance and endpoint assessment within clinical trials especially in heart failure (HF) patients. However, data regarding the availability of digital infrastructure and patients' willingness to use digital health solutions are scarce. Therefore, we conducted a survey as part of a digital-based HF registry.
Digital health intervention in patients with recent hospitalization for acute heart failure: A systematic review and meta-analysis of randomized trials. [2022]To examine the efficacy of digital health interventions (DHI) versus standard of care among patients with prior heart failure (HF) hospitalization.
Artificial intelligence supported patient self-care in chronic heart failure: a paradigm shift from reactive to predictive, preventive and personalised care. [2020]Heart failure (HF) is one of the most complex chronic disorders with high prevalence, mainly due to the ageing population and better treatment of underlying diseases. Prevalence will continue to rise and is estimated to reach 3% of the population in Western countries by 2025. It is the most important cause of hospitalisation in subjects aged 65 years or more, resulting in high costs and major social impact. The current "one-size-fits-all" approach in the treatment of HF does not result in best outcome for all patients. These facts are an imminent threat to good quality management of patients with HF. An unorthodox approach from a new vision on care is required. We propose a novel predictive, preventive and personalised medicine approach where patients are truly leading their management, supported by an easily accessible online application that takes advantage of artificial intelligence. This strategy paper describes the needs in HF care, the needed paradigm shift and the elements that are required to achieve this shift. Through the inspiring collaboration of clinical and high-tech partners from North-West Europe combining state of the art HF care, artificial intelligence, serious gaming and patient coaching, a virtual doctor is being created. The results are expected to advance and personalise self-care, where standard care tasks are performed by the patients themselves, in principle without involvement of healthcare professionals, the latter being able to focus on complex conditions. This new vision on care will significantly reduce costs per patient while improving outcomes to enable long-term sustainability of top-level HF care.