Heart FailureNCT05377190
Continuum: Digital Health to Manage Heart Failure Outpatients
A study testing Continuum HFC-IN and Continuum HFC-OUT in people with Heart Failure and Chronic Heart Failure, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Chronic Heart Failure
- What is being tested?
- Continuum HFC-IN and Continuum HFC-OUT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jun 2022to 24 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuum: Digital Health as Part of the Care Trajectory of 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.
Read the 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.
- Conditions
- Heart Failure, Chronic Heart Failure
- Being tested
- Continuum HFC-IN, Standard of care for the follow-up, Continuum HFC-OUT
- Keywords
- Digital health, Digital therapeutics, Software as medical device, Remote patient management, Telemonitoring, Mobile health, Guideline-Directed Medical Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuum HFC-INOther
Combination of a mobile application (with remote monitoring) and digital therapeutics
Standard of care for the follow-upOther
No mobile application or digital therapeutics are used
Continuum HFC-OUTOther
Combination of a mobile application (without remote monitoring) and digital therapeutics
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: 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. Receives: Other: Standard of care for the follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLIC IN ONLY: care consumption
Cost analysis on number of hospital (planned or unplanned) ambulatory visits, emergency visits, consultations and hospitalizations
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (9)
CLIC OUT ONLY: Care consumption
Cost analysis on number of hospital (planned or unplanned) ambulatory visits, emergency visits, consultations and hospitalizations during intervention
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks
CLIC IN ONLY: Quality of life assessment (QoL) with the Kansas City Cardiomyopathy Questionnaire
Differences in score before and after
Measured: 12 weeks
Quality of life assessment (QoL) with the EQ-5D-5L EuroQOL instrument
Differences in score before and after
Measured: 12 weeks
New York Heart Association class
A reduction of at least one class in New York Heart Association (NYHA) scale
Measured: 12 weeks
NTproBNP
Reduction in NTproBNP greater than 30%
Measured: 12 weeks
Pharmacological profile
Percentage of recommended heart failure drugs prescribed
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start8 Jun 2022
- Primary completion24 Oct 2023
- Study completion24 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Greybox, Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- François Tournoux, MD PhD, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377190
- Sponsor's protocol ID
- 2022-10426
- Status last verified
- Aug 2024
- First submitted
- 5 May 2022
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39504548
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuum: Digital Health as Part of the Care Trajectory of Heart Failure Outpatients
- ClinicalTrials.gov ID
- NCT05377190
- Acronym / sponsor ID
- 2022-10426
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Greybox, Boehringer Ingelheim
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 24 Oct 2023 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| For patients followed in a heart failure clinic (HFC), intervention HFC-IN | Experimental | Other: Continuum HFC-INUse of the full Continuum solution: remote patient monitoring and digital therapeutics over a period of 12 weeks |
| For patients followed in a HFC, control HFC-IN | Placebo comparator | Other: Standard of care for the follow-upStandard 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. |
| For patients not followed in a HFC, intervention HFC-OUT | Experimental | Other: Continuum HFC-OUTUse 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. |
| For patients not followed in a HFC, control HFC-OUT | Placebo comparator | Other: Standard of care for the follow-upStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuum HFC-INCombination of a mobile application (with remote monitoring) and digital therapeutics | Other | For patients followed in a heart failure clinic (HFC), intervention HFC-IN |
| Standard of care for the follow-upNo mobile application or digital therapeutics are used | Other | For patients followed in a HFC, control HFC-IN, For patients not followed in a HFC, control HFC-OUT |
| Continuum HFC-OUTCombination of a mobile application (without remote monitoring) and digital therapeutics | Other | For patients not followed in a HFC, intervention HFC-OUT |
Primary outcome
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
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.
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.
9 secondary outcomes
CLIC OUT ONLY: Care consumption
Time frame: 12 weeks
CLIC IN ONLY: Change in guideline-directed medical therapy by classes
Time frame: 12 weeks
CLIC IN ONLY: Change in guideline-directed medical therapy by doses
Time frame: 12 weeks
MACE and other clinical events
Time frame: 12 weeks
CLIC IN ONLY: Quality of life assessment (QoL) with the Kansas City Cardiomyopathy Questionnaire
Time frame: 12 weeks
Quality of life assessment (QoL) with the EQ-5D-5L EuroQOL instrument
Time frame: 12 weeks
New York Heart Association class
Time frame: 12 weeks
NTproBNP
Time frame: 12 weeks
Pharmacological profile
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Derived from this study: PubMed 39504548Marier-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.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Tournoux, MD PhD principal investigator
CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuum HFC-IN and Continuum HFC-OUT in people with Heart Failure and Chronic Heart Failure, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CLIC IN ONLY: care consumption (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05377190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.