NCT05377190

Continuum: Digital Health to Manage Heart Failure Outpatients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure
• Chronic Heart Failure

Interventions

Type	Name	Description
OTHER	Continuum HFC-IN	Combination of a mobile application (with remote monitoring) and digital therapeutics
OTHER	Standard of care for the follow-up	No mobile application or digital therapeutics are used
OTHER	Continuum HFC-OUT	Combination of a mobile application (without remote monitoring) and digital therapeutics

Timeline

• Start date: 2022-06-08
• Primary completion: 2023-10-24
• Completion: 2023-10-24
• First posted: 2022-05-17
• Last updated: 2024-08-09

Locations

1 site across 1 country: Canada