Continuum: Digital Health to Manage Heart Failure Outpatients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure, Chronic Heart Failure

Intervention / Treatment
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* Other: Continuum HFC-IN
* Other: Standard of care for the follow-up
* Other: Continuum HFC-OUT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: For patients followed in a heart failure clinic (HFC), intervention HFC-IN<br>Use of the full Continuum solution: remote patient monitoring and digital therapeutics over a period of 12 weeks | Other: Continuum HFC-IN<br>* Combination of a mobile application (with remote monitoring) and digital therapeutics<br>|
| Placebo Comparator: For patients followed in a HFC, control HFC-IN<br>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. | Other: Standard of care for the follow-up<br>* No mobile application or digital therapeutics are used<br>|
| Experimental: For patients not followed in a HFC, intervention HFC-OUT<br>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. | Other: Continuum HFC-OUT<br>* Combination of a mobile application (without remote monitoring) and digital therapeutics<br>|
| Placebo Comparator: For patients not followed in a HFC, control HFC-OUT<br>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. | Other: Standard of care for the follow-up<br>* No mobile application or digital therapeutics are used<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CLIC IN ONLY: care consumption | Cost analysis on number of hospital (planned or unplanned) ambulatory visits, emergency visits, consultations and hospitalizations | 12 weeks | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| CLIC IN ONLY: Quality of life assessment (QoL) with the Kansas City Cardiomyopathy Questionnaire | Differences in score before and after | 12 weeks | 
| Quality of life assessment (QoL) with the EQ-5D-5L EuroQOL instrument | Differences in score before and after | 12 weeks | 
| New York Heart Association class | A reduction of at least one class in New York Heart Association (NYHA) scale | 12 weeks | 
| NTproBNP | Reduction in NTproBNP greater than 30% | 12 weeks | 
| Pharmacological profile | Percentage of recommended heart failure drugs prescribed | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital therapeutics, Software as medical device, Remote patient management, Telemonitoring, Mobile health, Guideline-Directed Medical Therapy, Digital health