Continuum: Digital Health to Manage Heart Failure Outpatients

NCT05377190 | Completed

• 1 other identifier: 2022-10426
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Chronic Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• CLIC OUT ONLY: Care consumption

  12 weeks

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

  12 weeks

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

  12 weeks

• MACE and other clinical events

  12 weeks

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

  12 weeks

Study Arms (4)

For patients followed in a heart failure clinic (HFC), intervention HFC-IN

EXPERIMENTAL

Use of the full Continuum solution: remote patient monitoring and digital therapeutics over a period of 12 weeks

Other: Continuum HFC-IN

For patients followed in a HFC, control HFC-IN

PLACEBO COMPARATOR

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

For patients not followed in a HFC, intervention HFC-OUT

EXPERIMENTAL

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

For patients not followed in a HFC, control HFC-OUT

PLACEBO COMPARATOR

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

Interventions

Continuum HFC-IN OTHER

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

For patients followed in a heart failure clinic (HFC), intervention HFC-IN

Standard of care for the follow-up OTHER

No mobile application or digital therapeutics are used

For patients followed in a HFC, control HFC-IN; For patients not followed in a HFC, control HFC-OUT

Continuum HFC-OUT OTHER

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

For patients not followed in a HFC, intervention HFC-OUT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Greybox: collaborator
• Boehringer Ingelheim: collaborator

Study Sites (1)

CRCHUM

Montreal, Quebec, H2X 0A9, Canada

Location

Related Publications (1)

• 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.

  PMID: 39504548 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• François Tournoux, MD PhD

  CHUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 17, 2022
• Study Start: June 8, 2022
• Primary Completion: October 24, 2023
• Study Completion: October 24, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)