Continuum: Digital Health to Manage Heart Failure Outpatients

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05377190
• Other study ID #: 2022-10426
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 8, 2022
• Est. completion date: June 2024

Study information

• Verified date: April 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Canada	CRCHUM	Montréal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Boehringer Ingelheim, Greybox

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CLIC IN ONLY: care consumption	Cost analysis on number of hospital (planned or unplanned) ambulatory visits, emergency visits, consultations and hospitalizations	12 weeks
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	CLIC IN ONLY: Quality of life assessment (QoL) with the Kansas City Cardiomyopathy Questionnaire	Differences in score before and after	12 weeks
Secondary	Quality of life assessment (QoL) with the EQ-5D-5L EuroQOL instrument	Differences in score before and after	12 weeks
Secondary	New York Heart Association class	A reduction of at least one class in New York Heart Association (NYHA) scale	12 weeks
Secondary	NTproBNP	Reduction in NTproBNP greater than 30%	12 weeks
Secondary	Pharmacological profile	Percentage of recommended heart failure drugs prescribed	12 weeks