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Digital Therapeutics

Digital Health Management for Heart Failure

N/A
Waitlist Available
Led By François Tournoux, MD PhD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will test the effects of a digital therapeutics software solution on patients with heart failure. The goal is to see if the software can help reduce hospitalizations and improve management of the disease.

Who is the study for?
This trial is for heart failure patients who can use a mobile app (or have help), recently diagnosed, had an emergency or hospital visit due to heart failure, or had changes in their diuretic treatment. It's not for those with recent major heart procedures, current hospitalization, minors, pregnant women, poor short-term prognosis, on active dialysis or transplant lists, non-adherence history, severe depression without support, other study participation, substance abuse issues.Check my eligibility
What is being tested?
The Continuum study tests digital solutions for managing heart failure: the HFC-IN and HFC-OUT software against standard care. The goal is to see if these tools reduce hospital visits and improve patient management remotely in both specialized clinics and primary healthcare settings.See study design
What are the potential side effects?
Since this trial involves digital health tools rather than medications or invasive treatments, traditional side effects are not expected. However participants may experience technical issues or stress related to using new technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was recently diagnosed with heart failure or my condition has recently worsened.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CLIC IN ONLY: care consumption
CLIC OUT ONLY: Change in guideline-directed medical therapy by classes
CLIC OUT ONLY: Change in guideline-directed medical therapy by dose
Secondary outcome measures
CLIC IN ONLY: Change in guideline-directed medical therapy by classes
CLIC IN ONLY: Change in guideline-directed medical therapy by doses
CLIC IN ONLY: Quality of life assessment (QoL) with the Kansas City Cardiomyopathy Questionnaire
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: For patients not followed in a HFC, intervention HFC-OUTExperimental Treatment1 Intervention
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 II: For patients followed in a heart failure clinic (HFC), intervention HFC-INExperimental Treatment1 Intervention
Use of the full Continuum solution: remote patient monitoring and digital therapeutics over a period of 12 weeks
Group III: For patients not followed in a HFC, control HFC-OUTPlacebo Group1 Intervention
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 IV: For patients followed in a HFC, control HFC-INPlacebo Group1 Intervention
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.

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Who is running the clinical trial?

GreyboxUNKNOWN
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
365 Previous Clinical Trials
128,909 Total Patients Enrolled
2 Trials studying Heart Failure
356 Patients Enrolled for Heart Failure
Boehringer IngelheimIndustry Sponsor
2,494 Previous Clinical Trials
10,916,472 Total Patients Enrolled
25 Trials studying Heart Failure
119,728 Patients Enrolled for Heart Failure

Media Library

Continuum (Digital Therapeutics) Clinical Trial Eligibility Overview. Trial Name: NCT05377190 — N/A
Heart Failure Research Study Groups: For patients not followed in a HFC, control HFC-OUT, For patients followed in a heart failure clinic (HFC), intervention HFC-IN, For patients not followed in a HFC, intervention HFC-OUT, For patients followed in a HFC, control HFC-IN
Heart Failure Clinical Trial 2023: Continuum Highlights & Side Effects. Trial Name: NCT05377190 — N/A
Continuum (Digital Therapeutics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05377190 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you explain the core aims of this research project?

"Boehringer Ingelheim, the trial sponsor, has set twelve weeks as their primary measurement period. During this time they will assess care consumption and Quality of Life (QoL) changes with the Kansas City Cardiomyopathy Questionnaire. Additionally, Boehringer's secondary objectives are to track a reduction in New york Heart Association classifications and compare guideline-Directed Medical Therapy optimization across medication classes pre-and post-intervention."

Answered by AI

Are participants being accepted into this clinical research project?

"As per the clinicaltrials.gov listing, this trial is actively seeking patients to participate in their research. This study was initially published on June 8th 2022 and recently updated on November 22nd 2022."

Answered by AI

How many test subjects are actively involved in the trial?

"Affirmative, according to the clinicaltrials.gov information this trial is actively recruiting participants. This research was initiated on June 8th 2022 and revised November 22nd of that same year. 400 individuals are required for enrollment at one facility."

Answered by AI
~145 spots leftby Mar 2025