Clinical trial NCT05377190: Continuum: Digital Health to Manage Heart Failure Outpatients
Official title: Continuum: Digital Health as Part of the Care Trajectory of Heart Failure Outpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Chronic Heart Failure
Keywords: Digital health
Digital therapeutics
Software as medical device
Remote patient management
Telemonitoring
Mobile health
Guideline-Directed Medical Therapy
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Greybox
name: Boehringer Ingelheim
First posted: 2022-05-17
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: CLIC IN ONLY: care consumption
timeFrame: 12 weeks
measure: CLIC OUT ONLY: Change in guideline-directed medical therapy by classes
timeFrame: 12 weeks
measure: CLIC OUT ONLY: Change in guideline-directed medical therapy by dose
timeFrame: 12 weeks
Secondary outcomes:
measure: CLIC OUT ONLY: Care consumption
timeFrame: 12 weeks
measure: CLIC IN ONLY: Change in guideline-directed medical therapy by classes
timeFrame: 12 weeks
measure: CLIC IN ONLY: Change in guideline-directed medical therapy by doses
timeFrame: 12 weeks
measure: MACE and other clinical events
timeFrame: 12 weeks
measure: CLIC IN ONLY: Quality of life assessment (QoL) with the Kansas City Cardiomyopathy Questionnaire
timeFrame: 12 weeks
measure: Quality of life assessment (QoL) with the EQ-5D-5L EuroQOL instrument
timeFrame: 12 weeks
measure: New York Heart Association class
timeFrame: 12 weeks
measure: NTproBNP
timeFrame: 12 weeks
measure: Pharmacological profile
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CRCHUM
state: Quebec
Study officials:
affiliation: CHUM
name: François Tournoux, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: