Heart FailureNCT04993287
The Cascade Feasibility Pilot (HF) Phase 3
A study testing Non-invasive continuous remote monitoring with structured escalation pathway and Affective Analysis of Participant Response to Continuous Remote Patient Monitoring in people with Heart Failure, run by Endeavor Health at 1 site in United States.
Trial summary
The study proposal is to deploy a wearable solution that predicts physiological perturbation comparable to invasive devices and to perform continuous remote patient monitoring; this will be connected to a structured, cascading, escalation pathway involving home health nurses, advanced practitioner providers, and heart… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Non-invasive continuous remote monitoring with structured escalation pathway and Affective Analysis of Participant Response to Continuous Remote Patient Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is an inpatient at Evanston Hospital
- Patient is followed by the heart failure service team after discharge
- Patient has a history of heart failure
- Patient received at least one dose of IV diuretic at index hospitalization
- Symptoms corresponding to NYHA function class II-IV
- Patient has heart failure with reduced left ventricular ejection fraction (LVEF)<40%, or HF with mid-ranged ejection fraction (LVEF 40-50%), or HF with preserved ejection fraction (LVEF≥50%)
Show all 10Show fewer
- Patient is in the top 50% risk of readmission across NorthShore University HealthSystem's CAPE 30-day readmission model
- Patient is at least 18 years of age
- Patient is fluent in English
- Patient agrees to protocol-required procedures
Who cannot join
- Patient has cognitive or physical limitations that, in the investigator's opinion, limit the patient's ability to maintain patch device and phone
- Patient has visual impairments
- Patient has an allergy to hydrocolloid adhesives
- Patient has present skin damage preventing them from wearing a study device
- Patient has renal dysfunction requiring dialysis
- Patient has CardioMEMS
- Pregnancy
- Patient receiving hospice care
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University HealthSystem Evanston Hospital
Evanston, Illinois, 60201
About this study
Official title: The Cascade Feasibility Pilot (HF): Improving Care Processes for Heart Failure Patients Using Continuous Remote Patient Monitoring and a Cascading Alert System
The study proposal is to deploy a wearable solution that predicts physiological perturbation comparable to invasive devices and to perform continuous remote patient monitoring; this will be connected to a structured, cascading, escalation pathway involving home health nurses, advanced practitioner providers, and heart failure specialists, and has the potential to transform heart failure management in the post-discharge period, where patients are the most vulnerable for readmission. This feasibility study will contribute to the understanding of post-discharge heart failure continuous remote patient monitoring, promote patient self-care, and has the potential of improving patient outcomes.
Read the detailed description
Heart failure is a leading cause of hospital readmission. It results in significant mortality, morbidity, and health care utilization. Effective continuous remote patient monitoring (CRPM) can reduce readmissions, but it has only been realized via invasive monitoring. The study will focus on non-invasive heart failure CRPM through a structured cascading and escalating alert system. In this feasibility study, the study team will use a wearable biosensor and collect ambulatory physiological data that are analyzed by machine learning algorithms, potentially identifying physiological perturbation in heart failure patients. Alerts from this algorithm may be cascaded with other patient status data to inform management by the home health team via a structured protocol. The escalation pathway will engage home health, advanced practitioner providers, and heart failure specialists. In the first aim, the study team will perform a soft launch on five patients with an extensive evaluation to assess feasibility for the pilot trial. In aim 2, the study team will implement the feasibility pilot study. In aim 2a, the study team will conduct surveys and semi-structured interviews with both providers and patients. The surveys and interviews will be applied at three time points (initiation, maintenance, and post-study) to evaluate perceptions, acceptance, and experience of this CRPM solution. In aim 2b, the investigators will leverage temporal data mining, feature extraction, and patient clustering methods to identify valid patterns associated with the pathophysiological events of interest, using continuous physiological data, patient reports, and electronic health record data. The study team will also compare outcome and process measures from our pilot study to a retrospective cohort matched for key demographics and disease severity. This feasibility study will provide key learning for a larger efficacy clinical trial to evaluate if this non-invasive telemonitoring solution tied to structured patient management via cascading and escalating alert pathways can improve outcomes and reduce heart failure readmission.
- Conditions
- Heart Failure
- Being tested
- Non-invasive continuous remote monitoring with structured escalation pathway, Affective Analysis of Participant Response to Continuous Remote Patient Monitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive continuous remote monitoring with structured escalation pathwayOther
Continuous patient monitoring through non-invasive biosensors coupled with machine learning algorithms, with a structured escalation and communication pathway for home health providers and HF care team
Affective Analysis of Participant Response to Continuous Remote Patient MonitoringOther
Surveys and interviews with enrolled participants
| Study group | Role | What they receive |
|---|---|---|
| Pilot | Experimental | 39 eligible HF patients Receives: Other: Non-invasive continuous remote monitoring with structured escalation pathway; Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate
Enrollment rate for entire patient cohort
Measured: Through study completion, an average 1 year
Adherence Rate
Patient adherence to electronic patient reported outcomes
Measured: Through study completion, an average of one year
Secondary outcomes (2)
Documented Diuretic Escalation
Number of patients on escalated diuretics dosage by the clinical care team during monitoring period
Measured: 30 days from patient discharge date
30-day Readmission Rate
30-day readmission rate from the day of discharge
Measured: 30 days from patient discharge date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start17 Jun 2021
- Primary completion30 Mar 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nirav Shah, Endeavor Health
- Investigators
- Nirav S Shah, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993287
- Sponsor's protocol ID
- EH20-288 Cascade HF
- Status last verified
- Mar 2025
- First submitted
- 16 Jul 2021
- Last updated
- 3 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cascade Feasibility Pilot (HF): Improving Care Processes for Heart Failure Patients Using Continuous Remote Patient Monitoring and a Cascading Alert System
- ClinicalTrials.gov ID
- NCT04993287
- Acronym / sponsor ID
- EH20-288 Cascade HF
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Posted 3 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study proposal is to deploy a wearable solution that predicts physiological perturbation comparable to invasive devices and to perform continuous remote patient monitoring; this will be connected to a structured, cascading, escalation pathway involving home health nurses, advanced practitioner providers, and heart failure specialists, and has the potential to transform heart failure management in the post-discharge period, where patients are the most vulnerable for readmission. This feasibility study will contribute to the understanding of post-discharge heart failure continuous remote patient monitoring, promote patient self-care, and has the potential of improving patient outcomes.
Detailed description
Heart failure is a leading cause of hospital readmission. It results in significant mortality, morbidity, and health care utilization. Effective continuous remote patient monitoring (CRPM) can reduce readmissions, but it has only been realized via invasive monitoring. The study will focus on non-invasive heart failure CRPM through a structured cascading and escalating alert system. In this feasibility study, the study team will use a wearable biosensor and collect ambulatory physiological data that are analyzed by machine learning algorithms, potentially identifying physiological perturbation in heart failure patients. Alerts from this algorithm may be cascaded with other patient status data to inform management by the home health team via a structured protocol. The escalation pathway will engage home health, advanced practitioner providers, and heart failure specialists. In the first aim, the study team will perform a soft launch on five patients with an extensive evaluation to assess feasibility for the pilot trial. In aim 2, the study team will implement the feasibility pilot study. In aim 2a, the study team will conduct surveys and semi-structured interviews with both providers and patients. The surveys and interviews will be applied at three time points (initiation, maintenance, and post-study) to evaluate perceptions, acceptance, and experience of this CRPM solution. In aim 2b, the investigators will leverage temporal data mining, feature extraction, and patient clustering methods to identify valid patterns associated with the pathophysiological events of interest, using continuous physiological data, patient reports, and electronic health record data. The study team will also compare outcome and process measures from our pilot study to a retrospective cohort matched for key demographics and disease severity. This feasibility study will provide key learning for a larger efficacy clinical trial to evaluate if this non-invasive telemonitoring solution tied to structured patient management via cascading and escalating alert pathways can improve outcomes and reduce heart failure readmission.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot | Experimental | Other: Non-invasive continuous remote monitoring with structured escalation pathway, Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring39 eligible HF patients |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient is an inpatient at Evanston Hospital
- Patient is followed by the heart failure service team after discharge
- Patient has a history of heart failure
- Patient received at least one dose of IV diuretic at index hospitalization
- Symptoms corresponding to NYHA function class II-IV
Key exclusion criteria (8 listed)
- Patient has cognitive or physical limitations that, in the investigator's opinion, limit the patient's ability to maintain patch device and phone
- Patient has visual impairments
- Patient has an allergy to hydrocolloid adhesives
- Patient has present skin damage preventing them from wearing a study device
- Patient has renal dysfunction requiring dialysis
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 |
|---|---|---|
| Non-invasive continuous remote monitoring with structured escalation pathwayContinuous patient monitoring through non-invasive biosensors coupled with machine learning algorithms, with a structured escalation and communication pathway for home health providers and HF care team | Other | Pilot |
| Affective Analysis of Participant Response to Continuous Remote Patient MonitoringSurveys and interviews with enrolled participants | Other | Pilot |
Primary outcome
Enrollment Rate
Time frame: Through study completion, an average 1 year
Enrollment rate for entire patient cohort
Adherence Rate
Time frame: Through study completion, an average of one year
Patient adherence to electronic patient reported outcomes
2 secondary outcomes
Documented Diuretic Escalation
Time frame: 30 days from patient discharge date
30-day Readmission Rate
Time frame: 30 days from patient discharge date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
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Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
HFrEF - Heart Failure With Reduced Ejection Fraction
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A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
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Active, not recruiting
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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.
Nirav S Shah principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive continuous remote monitoring with structured escalation pathway and Affective Analysis of Participant Response to Continuous Remote Patient Monitoring in people with Heart Failure, run by Endeavor Health at 1 site in United States.
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 10 inclusion and 8 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 3 Apr 2025. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 3 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Enrollment Rate (time frame: Through study completion, an average 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2025.