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

Primary Purpose

Heart Failure

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Virtual HF Care

Routine HF Care

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring Heart Failure, Randomized Controlled Trial, Digital Health, Knowledge Translation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients ≥ 18 years old who: 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 have left ventricular ejection fraction (LVEF) < 55% within the preceding 3 months Have NT-proBNP of > 900 pg/ml 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 provide consent.

Sites / Locations

St. Joseph's Healthcare HamiltonRecruiting
Hamilton General HospitalRecruiting
Juravinski Hospital Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Virtual HF care

Routine HF care

Arm Description

Patients will receive virtual HF care to optimize medical therapies

Participants will receive routine HF care

Outcomes

Primary Outcome Measures

Change in heath status

Secondary Outcome Measures

Number of patients randomized

Proportion of patients allocated to the virtual HF clinic who require crossover to the routine HF clinic

Proportion of patients that are seen in clinic within 7 days post discharge

Proportion of patients on all classes of guideline-directed medical therapy (GDMT) at baseline, 30 days and 90 days

Proportion of patients who have heath status data collected at baseline, 30 days and 90 days

Qualitative feedback on patient satisfaction and usability of technology

Number of visits per patient during 90 days

Full Information

NCT ID

NCT05724433

First Posted

August 31, 2019

Last Updated

February 1, 2023

Sponsor

Population Health Research Institute

Collaborators

Hamilton Health Sciences Corporation, McMaster University

1. Study Identification

Unique Protocol Identification Number

NCT05724433

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 9, 2022 (Actual)

Primary Completion Date

June 9, 2023 (Anticipated)

Study Completion Date

November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Population Health Research Institute

Collaborators

Hamilton Health Sciences Corporation, McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

Heart Failure, Randomized Controlled Trial, Digital Health, Knowledge Translation

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Virtual HF care

Arm Type

Experimental

Arm Description

Patients will receive virtual HF care to optimize medical therapies

Arm Title

Routine HF care

Arm Type

Other

Arm Description

Participants will receive routine HF care

Intervention Type

Other

Intervention Name(s)

Virtual HF Care

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Routine HF Care

Intervention Description

Care as determined by the treating physician

Primary Outcome Measure Information:

Title

Change in heath status

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Number of patients randomized

Time Frame

90 days

Title

Proportion of patients allocated to the virtual HF clinic who require crossover to the routine HF clinic

Time Frame

90 days

Title

Proportion of patients that are seen in clinic within 7 days post discharge

Time Frame

date of discharge to 7 days

Title

Proportion of patients on all classes of guideline-directed medical therapy (GDMT) at baseline, 30 days and 90 days

Time Frame

90 days

Title

Proportion of patients who have heath status data collected at baseline, 30 days and 90 days

Time Frame

90 days

Title

Qualitative feedback on patient satisfaction and usability of technology

Time Frame

90 days

Title

Number of visits per patient during 90 days

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Harriette GC Van Spall, MD MPH

Phone

(905) 521-2100

Ext

40601

Harriette.VanSpall@phri.ca

First Name & Middle Initial & Last Name or Official Title & Degree

VICTORY-HF Project office

victory-hf@phri.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harriette Van Spall, MD

Organizational Affiliation

McMaster University

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Joseph's Healthcare Hamilton

City

Hamilton

State/Province

Onatrio

ZIP/Postal Code

L8N 4A6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katie Connolly, Dr

Facility Name

Hamilton General Hospital

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Harriette VanSpall, Dr

Facility Name

Juravinski Hospital Cancer Centre

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 5C2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Serena Gundy, Dr.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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