Continuum: Digital Health to Manage Heart Failure Outpatients

Continuum: Digital Health as Part of the Care Trajectory of Heart Failure Outpatients

Heart failure (HF) is one of the leading causes of hospitalization and death worldwide. Remote patient monitoring and digital therapeutics could help reduce the consumption of care for these patients (hospitalizations, emergency room visits) and optimize their management (education, medication optimization). This randomized study aims to evaluate the effects of the Continuum software solution in patients with heart failure, whether or not they are followed in specialized clinics. Heart failure is one of the main causes of hospitalization and death in the world. Evidence suggests that remote patient monitoring (RPM) and digital therapeutics (DTX solutions) can help improve care consumption (i.e. hospitalizations, emergency visits) and also support health care professionals to improve care (i.e. symptoms management, drug optimization). This randomised study aims to evaluate the effects of these two software solutions in the context of specialized HF clinics (HFC) and primary health care on health care consumption and clinical events.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Chronic Heart Failure
• Intervention / Treatment: Other: Continuum HFC-IN; Other: Standard of care for the follow-up; Other: Continuum HFC-OUT

Detailed Description

According to Canadian recommendations, patients recently diagnosed with heart failure or with a recent hospitalization should have a medical follow-up every two to four weeks in order to optimize their treatment and quickly stabilize their condition. However, despite a network of specialized heart failure clinics in the province of Quebec, access to this service is still a challenge because of limited human resources and unequal geographic distribution. Only the most severely ill and unstable patients are followed in these clinics.

The Continuum project combines a remote patient monitoring solution with therapeutic interventions driven by a software to manage heart failure (also called digital therapeutics (DTx)). The patient can send her/his clinical data to the healthcare professional using a mobile application. Healthcare professionals receive not only these data in realtime with potential alerts but also a summarized report of these data and suggested therapeutic interventions.

Our hypotheses are that the Continuum solution, by combining RPM and DTx will 1) improve the workflow and the care trajectory of patients in heart failure clinics resulting in a reduction of cost per patient followed and 2) accelerate drug optimization so they can fully benefit from the recommended therapies for their specific condition.

The general objective of this project is to assess in outpatients the effectiveness of the Continuum solution to reduce healthcare costs and to support medication optimization over a period of 12 weeks.

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 0A9
      • CRCHUM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

HFC-IN

Inclusion Criteria:

• HF diagnostic
• NYHA 2 or +
• Active follow-up in heart failure clinic
• Ability to use mobile app (or with caregiver's help)
• And one of the following
• New HF diagnosis (<3 months)
• Emergency visit or recent hospitalization with decompensated HF (<6months)
• Increase of >50% diuretic dose, new diuretic or IV diuretic (last 3 months)
• Active heart failure follow-up 2 times in the last 3 months

HFC-OUT

Inclusion Criteria:

• HF diagnostic
• Ability to use mobile app (or with caregiver's help)
• No active follow-up in heart failure clinic or in the waiting list of one

Exclusion Criteria for HFC-IN and HFC-OUT:

• Active hospitalization at randomization or anticipated in the next 2 weeks
• Incapable or minor patient
• History of non-adherence or treatment refusal
• Alcohol or drugs abuse
• Active major depression without caregiver
• Global prognosis < 3months
• Active dialysis or on waiting list
• Heart transplant or mechanical heart
• Severe pulmonary disease with oxygen use or pulmonary transplant waiting list or recurrent pleural drainage
• Severe chronic cirrhosis or hepatic transplant waiting list or recurrent ascites drainage
• Percutaneous or surgical intervention in last 30 days or planned in next 3 months
• Pregnancy
• Active follow-up in another study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: For patients followed in a heart failure clinic (HFC), intervention HFC-IN; Use of the full Continuum solution: remote patient monitoring and digital therapeutics over a period of 12 weeks	Other: Continuum HFC-IN; Combination of a mobile application (with remote monitoring) and digital therapeutics
Placebo Comparator: For patients followed in a HFC, control HFC-IN; Standard of care for the follow-up, no use of remote monitoring or digital therapeutics for the first 12 weeks. After 12 weeks, option is given to the patient to use the full Continuum solution for another period of 12 weeks.	Other: Standard of care for the follow-up; No mobile application or digital therapeutics are used
Experimental: For patients not followed in a HFC, intervention HFC-OUT; Use of part of the Continuum solution: the patient will use a mobile application to enter her/his data but no remote monitoring is performed. Digital therapeutics are used for the healthcare professionals.	Other: Continuum HFC-OUT; Combination of a mobile application (without remote monitoring) and digital therapeutics
Placebo Comparator: For patients not followed in a HFC, control HFC-OUT; Standard of care for the follow-up, no use of a mobile application or digital therapeutics for the first 12 weeks. After 12 weeks, option is given to the patient to use the mobile app and digital therapeutics are activated for another period of 12 weeks.	Other: Standard of care for the follow-up; No mobile application or digital therapeutics are used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CLIC IN ONLY: care consumption	Cost analysis on number of hospital (planned or unplanned) ambulatory visits, emergency visits, consultations and hospitalizations	12 weeks
CLIC OUT ONLY: Change in guideline-directed medical therapy by classes	Change in guideline-directed medical Therapy optimization between groups before and after intervention by medication classes.	12 weeks
CLIC OUT ONLY: Change in guideline-directed medical therapy by dose	Change in guideline-Directed Medical Therapy optimization between groups before and after intervention by medication doses.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CLIC OUT ONLY: Care consumption	Cost analysis on number of hospital (planned or unplanned) ambulatory visits, emergency visits, consultations and hospitalizations during intervention	12 weeks
CLIC IN ONLY: Change in guideline-directed medical therapy by classes	Compare guideline-Directed Medical Therapy optimization between groups before and after intervention by medication classes	12 weeks
CLIC IN ONLY: Change in guideline-directed medical therapy by doses	Compare guideline-Directed Medical Therapy optimization between groups before and after intervention by medication doses	12 weeks
MACE and other clinical events	Differences before-after between groups in number of main clinical events including unplanned appointments, emergency consults, all-cause or heart-failure hospitalizations, deaths	12 weeks
CLIC IN ONLY: Quality of life assessment (QoL) with the Kansas City Cardiomyopathy Questionnaire	Differences in score before and after	12 weeks
Quality of life assessment (QoL) with the EQ-5D-5L EuroQOL instrument	Differences in score before and after	12 weeks
New York Heart Association class	A reduction of at least one class in New York Heart Association (NYHA) scale	12 weeks
NTproBNP	Reduction in NTproBNP greater than 30%	12 weeks
Pharmacological profile	Percentage of recommended heart failure drugs prescribed	12 weeks

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Boehringer Ingelheim; Greybox
• Investigators: Principal Investigator: François Tournoux, MD PhD, CHUM

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Actual): October 24, 2023
• Study Completion (Actual): October 24, 2023

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Telemonitoring; Digital therapeutics; Mobile health; Digital health; Guideline-Directed Medical Therapy; Software as medical device; Remote patient management
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2022-10426

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No