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Continuum: Digital Health to Manage Heart Failure Outpatients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05377190
Enrollment
175
Registered
2022-05-17
Start date
2022-06-08
Completion date
2023-10-24
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure, Heart Failure

Keywords

Digital health, Digital therapeutics, Software as medical device, Remote patient management, Telemonitoring, Mobile health, Guideline-Directed Medical Therapy

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.

Interventions

OTHERContinuum HFC-IN

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

OTHERStandard of care for the follow-up

No mobile application or digital therapeutics are used

OTHERContinuum HFC-OUT

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

Sponsors

Greybox
CollaboratorUNKNOWN
Boehringer Ingelheim
CollaboratorINDUSTRY
Centre hospitalier de l'Université de Montréal (CHUM)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
CLIC IN ONLY: care consumption12 weeksCost analysis on number of hospital (planned or unplanned) ambulatory visits, emergency visits, consultations and hospitalizations
CLIC OUT ONLY: Change in guideline-directed medical therapy by classes12 weeksChange in guideline-directed medical Therapy optimization between groups before and after intervention by medication classes.
CLIC OUT ONLY: Change in guideline-directed medical therapy by dose12 weeksChange in guideline-Directed Medical Therapy optimization between groups before and after intervention by medication doses.

Secondary

MeasureTime frameDescription
MACE and other clinical events12 weeksDifferences before-after between groups in number of main clinical events including unplanned appointments, emergency consults, all-cause or heart-failure hospitalizations, deaths
CLIC IN ONLY: Quality of life assessment (QoL) with the Kansas City Cardiomyopathy Questionnaire12 weeksDifferences in score before and after
Quality of life assessment (QoL) with the EQ-5D-5L EuroQOL instrument12 weeksDifferences in score before and after
CLIC IN ONLY: Change in guideline-directed medical therapy by doses12 weeksCompare guideline-Directed Medical Therapy optimization between groups before and after intervention by medication doses
NTproBNP12 weeksReduction in NTproBNP greater than 30%
Pharmacological profile12 weeksPercentage of recommended heart failure drugs prescribed
New York Heart Association class12 weeksA reduction of at least one class in New York Heart Association (NYHA) scale
CLIC OUT ONLY: Care consumption12 weeksCost analysis on number of hospital (planned or unplanned) ambulatory visits, emergency visits, consultations and hospitalizations during intervention
CLIC IN ONLY: Change in guideline-directed medical therapy by classes12 weeksCompare guideline-Directed Medical Therapy optimization between groups before and after intervention by medication classes

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026