Virtual Care for Heart Failure - Randomized Clinical Trial (RCT) (Pilot Phase)

Heart Failure Clinical Trial

Official title:

VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization (VICTORY-HF) RCT (Pilot Phase)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05724433
• Other study ID #: VICTORY-HF RCT (Pilot Phase)
• Status: Recruiting
• Phase: N/A
• Start date: December 9, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: February 2023
• Source: Population Health Research Institute
• Contact: Harriette GC Van Spall, MD MPH
• Phone: (905) 521-2100
• Email: Harriette.VanSpall[@]phri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Heart failure (HF) is a leading cause of death, hospitalization, and healthcare system expenditure in Canada. While care in HF clinics - multidisciplinary clinics that focus on optimal management of HF - improves health outcomes in HF, there are disparities in access to such care across our province. To respond to the needs of patients and the health care system, the investigators propose to develop and implement a virtual model of care that will enable Canadians with HF to receive outpatient HF care and medical optimization remotely. The investigators will assess the feasibility of this model of care in a pilot randomized controlled trial, and collect feedback from patients and providers. The investigators hypothesize that virtual clinics will be feasible. The investigators will also measure healthcare processes, and use these to guide a larger clinical trial that will measure clinical outcomes in patients receiving virtual versus usual care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 30, 2023
• Est. primary completion date: June 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Adult patients = 18 years old who:

1. are being discharged after hospitalization or urgent visit (emergency department) for HF OR have been referred for an initial consult at a cardiology clinic within 30 days of hospitalization or urgent visit for HF

2. have left ventricular ejection fraction (LVEF) < 55% within the preceding 3 months

3. Have NT-proBNP of > 900 pg/ml

4. have a mailing address for the patient or caregiver

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

6. provide consent.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• 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

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Juravinski Hospital Cancer Centre	Hamilton	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Onatrio

Sponsors (3)

Lead Sponsor	Collaborator
Population Health Research Institute	Hamilton Health Sciences Corporation, McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heath status		90 days
Secondary	Number of patients randomized		90 days
Secondary	Proportion of patients allocated to the virtual HF clinic who require crossover to the routine HF clinic		90 days
Secondary	Proportion of patients that are seen in clinic within 7 days post discharge		date of discharge to 7 days
Secondary	Proportion of patients on all classes of guideline-directed medical therapy (GDMT) at baseline, 30 days and 90 days		90 days
Secondary	Proportion of patients who have heath status data collected at baseline, 30 days and 90 days		90 days
Secondary	Qualitative feedback on patient satisfaction and usability of technology		90 days
Secondary	Number of visits per patient during 90 days		90 days