VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization
NCT ID: NCT05724433
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
891 participants
INTERVENTIONAL
2023-01-23
2026-12-31
Brief Summary
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Detailed Description
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A pilot phase was conducted to assess the acceptability and feasibility of the intervention, assess change in health status, refine the virtual delivery process and healthcare processes, and use these to finalize protocols and guide the larger clinical trial. Data collection during the pilot phase focused on the process outcomes approved by HiREB (ID 5441).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
Patients and clinicians will be unblinded, but those analyzing data will be blinded. We will adopt a pragmatic approach to this study.
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Virtual HF care
Patients will receive virtual HF care to optimize medical therapies
Virtual HF Care
Patients will receive virtual visits for 3 months following hospitalization / emergency department (ED) visit for HF. Physiologic measures will be monitored remotely and therapies will be optimized.
Routine HF care
Participants will receive routine HF care
Routine HF Care
Care as determined by the treating physician
Interventions
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Virtual HF Care
Patients will receive virtual visits for 3 months following hospitalization / emergency department (ED) visit for HF. Physiologic measures will be monitored remotely and therapies will be optimized.
Routine HF Care
Care as determined by the treating physician
Eligibility Criteria
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Inclusion Criteria
1. Are being discharged after hospitalization or urgent visit for HF as
1. a primary diagnosis or
2. significant complication (prolonging length of stay) of another diagnosis OR Have been referred for an initial consult at a cardiology clinic within 1 week of hospitalization or urgent visit for HF as a primary or secondary diagnosis, as described above.
2. Have left ventricular ejection fraction (LVEF) \< 50% within the preceding 3 months.
3. Have NT-proBNP of \> 900 pg/ml during hospital admission or within 7 days after discharge from the ED
4. Have a mailing address for patient or caregiver
5. Provide verbal consent
Exclusion Criteria
2. Unable to self-assess or communicate symptoms (e.g. clinically evident dementia)
3. Unable to engage with digital health technology or follow up
4. Severe valve disease
5. Recipient of or on waiting list for LVAD or cardiac transplant
6. Complex congenital heart disease, hypertrophic obstructive cardiomyopathy, or amyloid cardiomyopathy
7. Severe lung disease with symptoms on minimal exertion, forced expiratory volume during 1 second (FEV1) \< 1 litre, severe pulmonary hypertension with RVSP \> 60 mm Hg, or on home oxygen
8. Severe kidney disease (persistent eGFR \< 30 mL/min/1.73m2)
9. Active malignancy
10. Receiving palliative care or expected life expectancy \< 6 months
18 Years
ALL
No
Sponsors
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Hamilton Health Sciences Corporation
OTHER
McMaster University
OTHER
Population Health Research Institute
OTHER
Responsible Party
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Harriette Van Spall
Assistant Professor of Medicine, Division of Cardiology, McMaster University, Population Health Research Institute
Principal Investigators
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Harriette Van Spall, MD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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St. Joseph's Healthcare Hamilton
Hamilton, Onatrio, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
Juravinski Hospital Cancer Centre
Hamilton, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
Unity Health Toronto
Toronto, Ontario, Canada
Fattouma Bourguiba Hospital
Monastir, , Tunisia
Hedi Chaker Hospital
Sfax, , Tunisia
Sahloul Hospital
Sousse, , Tunisia
Military Hospital
Tunis, , Tunisia
Countries
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Central Contacts
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Facility Contacts
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Katie Connolly, Dr
Role: primary
Harriette Van Spall, Dr
Role: primary
Serena Gundy, Dr.
Role: primary
Vahid Akbari
Role: primary
Peter Mitoff
Role: primary
Semir Nouira
Role: primary
Leila Abid
Role: primary
Riadh Boukef
Role: primary
Wafa Fehri
Role: primary
Other Identifiers
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VICTORY-HF RCT
Identifier Type: -
Identifier Source: org_study_id