Continuum: Digital Health to Manage Heart Failure Outpatients

NCT ID: NCT05377190

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-08
• Study Completion Date: 2023-10-24

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.

Conditions

Heart Failure; Chronic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Continuum HFC-IN

Intervention Type: OTHER

Combination of a mobile application (with remote monitoring) and digital therapeutics

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.

Group Type: PLACEBO_COMPARATOR

Standard of care for the follow-up

Intervention Type: OTHER

No mobile application or digital therapeutics are used

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.

Group Type: EXPERIMENTAL

Continuum HFC-OUT

Intervention Type: OTHER

Combination of a mobile application (without remote monitoring) and digital therapeutics

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.

Group Type: PLACEBO_COMPARATOR

Standard of care for the follow-up

Intervention Type: OTHER

No mobile application or digital therapeutics are used

Interventions

Continuum HFC-IN

Combination of a mobile application (with remote monitoring) and digital therapeutics

Intervention Type: OTHER

Standard of care for the follow-up

No mobile application or digital therapeutics are used

Intervention Type: OTHER

Continuum HFC-OUT

Combination of a mobile application (without remote monitoring) and digital therapeutics

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Greybox

UNKNOWN

Sponsor Role: collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François Tournoux, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHUM

Locations

CRCHUM

Montreal, Quebec, Canada

Countries

Canada

References

Marier-Tetrault E, Bebawi E, Bechard S, Brouillard P, Zuchinali P, Remillard E, Carrier Z, Jean-Charles L, Nguyen JNK, Lehoux P, Pomey MP, Ribeiro PAB, Tournoux F. Remote Patient Monitoring and Digital Therapeutics Enhancing the Continuum of Care in Heart Failure: Nonrandomized Pilot Study. JMIR Form Res. 2024 Nov 6;8:e53444. doi: 10.2196/53444.

Reference Type: DERIVED

PMID: 39504548 (View on PubMed)

Other Identifiers

2022-10426

Identifier Type: -

Identifier Source: org_study_id