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Completed

NCT Number: NCT05377190

Continuum: Digital Health to Manage Heart Failure Outpatients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CRCHUM

Montreal, Quebec, H2X 0A9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuum HFC-IN

Other

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

Standard of care for the follow-up

Other

No mobile application or digital therapeutics are used

Continuum HFC-OUT

Other

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

Primary outcomes

  1. CLIC IN ONLY: care consumption

    Time frame: 12 weeks

    Cost analysis on number of hospital (planned or unplanned) ambulatory visits, emergency visits, consultations and hospitalizations

  2. CLIC OUT ONLY: Change in guideline-directed medical therapy by classes

    Time frame: 12 weeks

    Change in guideline-directed medical Therapy optimization between groups before and after intervention by medication classes.

  3. CLIC OUT ONLY: Change in guideline-directed medical therapy by dose

    Time frame: 12 weeks

    Change in guideline-Directed Medical Therapy optimization between groups before and after intervention by medication doses.

Secondary outcomes

  1. CLIC OUT ONLY: Care consumption

    Time frame: 12 weeks

    Cost analysis on number of hospital (planned or unplanned) ambulatory visits, emergency visits, consultations and hospitalizations during intervention

  2. CLIC IN ONLY: Change in guideline-directed medical therapy by classes

    Time frame: 12 weeks

    Compare guideline-Directed Medical Therapy optimization between groups before and after intervention by medication classes

  3. CLIC IN ONLY: Change in guideline-directed medical therapy by doses

    Time frame: 12 weeks

    Compare guideline-Directed Medical Therapy optimization between groups before and after intervention by medication doses

  4. MACE and other clinical events

    Time frame: 12 weeks

    Differences before-after between groups in number of main clinical events including unplanned appointments, emergency consults, all-cause or heart-failure hospitalizations, deaths

  5. CLIC IN ONLY: Quality of life assessment (QoL) with the Kansas City Cardiomyopathy Questionnaire

    Time frame: 12 weeks

    Differences in score before and after

  6. Quality of life assessment (QoL) with the EQ-5D-5L EuroQOL instrument

    Time frame: 12 weeks

    Differences in score before and after

  7. New York Heart Association class

    Time frame: 12 weeks

    A reduction of at least one class in New York Heart Association (NYHA) scale

  8. NTproBNP

    Time frame: 12 weeks

    Reduction in NTproBNP greater than 30%

  9. Pharmacological profile

    Time frame: 12 weeks

    Percentage of recommended heart failure drugs prescribed

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Boehringer Ingelheim
  • Greybox

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 17, 2022
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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