Trial Outcomes & Findings for The Cascade Feasibility Pilot (HF) Phase 3 (NCT NCT04993287)

NCT ID: NCT04993287

Last Updated: 2025-04-03

Results Overview

Enrollment rate for entire patient cohort

Recruitment status

COMPLETED

Study phase

Target enrollment

54 participants

Primary outcome timeframe

Through study completion, an average 1 year

Results posted on

2025-04-03

Participant Flow

The study approached a total of 61 potential participants that signed that consent forms. Out of which 39 completed the study, 16 were screen failed and 6 withdrew the consent. 15 providers participated in the study

Participant milestones

Participant milestones
Measure	Pilot 39 eligible HF patients Non-invasive continuous remote monitoring with structured escalation pathway: 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 Monitoring: Surveys and interviews with enrolled participants	15 HF Providers Were Included in the Study HF providers who were part of advanced cardiology services were included in the study Non-invasive continuous remote monitoring with structured escalation pathway: 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
Overall Study STARTED	39	15
Overall Study COMPLETED	39	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Cascade Feasibility Pilot (HF) Phase 3

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pilot n=39 Participants 39 eligible HF patients and 15 HF providers Non-invasive continuous remote monitoring with structured escalation pathway: 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 Monitoring: Surveys and interviews with enrolled participants Baseline characteristics were not collected for HF proivders
Age, Customized	75 Years n=99 Participants
Sex: Female, Male Female	16 Participants n=99 Participants
Sex: Female, Male Male	23 Participants n=99 Participants
Race/Ethnicity, Customized African American	4 Participants n=99 Participants
Race/Ethnicity, Customized Asian	4 Participants n=99 Participants
Race/Ethnicity, Customized Caucasian	24 Participants n=99 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=99 Participants
Race/Ethnicity, Customized Other	6 Participants n=99 Participants
Smoking Current	2 Participants n=99 Participants
Smoking Former	19 Participants n=99 Participants
Smoking Never	18 Participants n=99 Participants
Comorbidities Diabetes Mellitus	17 Participants n=99 Participants
Comorbidities Hypertension	29 Participants n=99 Participants
Comorbidities CKD	23 Participants n=99 Participants
Comorbidities COPD	9 Participants n=99 Participants
Comorbidities AFIB	17 Participants n=99 Participants
Comorbidities Obesity (BMI)	20 Participants n=99 Participants
Comorbidities Depression	12 Participants n=99 Participants
Comorbidities Anxiety	13 Participants n=99 Participants
Comorbidities Myocardial infarction	4 Participants n=99 Participants
Comorbidities Implantable Defibrillator	7 Participants n=99 Participants
Comorbidities Cardioversion/Cardiac Resynchronization Therapy	4 Participants n=99 Participants
Heart Failure Severity New York Heart Association Class II	4 Participants n=99 Participants
Heart Failure Severity New York Heart Association Class III	30 Participants n=99 Participants
Heart Failure Severity New York Heart Association Class IV	5 Participants n=99 Participants
Heart Failure Severity Diastolic Heart Failure	17 Participants n=99 Participants
Heart Failure Severity Systolic Heart Failure	6 Participants n=99 Participants
Heart Failure Severity Systolic and Diastolic Heart Failure	15 Participants n=99 Participants
Heart Failure Severity Unspecified Type of Heart Failure	1 Participants n=99 Participants
Heart Failure Severity Heart Catherization in Index Stay	12 Participants n=99 Participants
Ejection Fraction	52 Percentage n=99 Participants
Ejection Fraction Type Heart failure with preserved ejection fraction (Ejection Fraction of greater than or equal to 50%)	21 Participants n=99 Participants
Ejection Fraction Type Heart failure with mid-range ejection fraction (Ejection Fraction of 41% to 49%)	4 Participants n=99 Participants
Ejection Fraction Type Heart failure with reduced ejection fraction (Ejection Fraction of less than 39%)	14 Participants n=99 Participants
Clinical Analytics Prediction Engine (CAPE) Readmission Risk Score	18 Percentage n=99 Participants
Insurance Type Commercial	10 Participants n=99 Participants
Insurance Type Government	0 Participants n=99 Participants
Insurance Type Medicaid	2 Participants n=99 Participants
Insurance Type Medicare	25 Participants n=99 Participants
Discharge Medications Digoxin	6 Participants n=99 Participants
Discharge Medications Loop diuretics	36 Participants n=99 Participants
Discharge Medications ACE/ARB-Antihypertensive medications	11 Participants n=99 Participants
Discharge Medications Beta blockers	29 Participants n=99 Participants
Discharge Medications Aldosterone Agonist - Spironolactone	24 Participants n=99 Participants

PRIMARY outcome

Timeframe: Through study completion, an average 1 year

Enrollment rate for entire patient cohort

Outcome measures

Outcome measures
Measure	Pilot n=39 Participants 39 eligible HF patients Non-invasive continuous remote monitoring with structured escalation pathway: 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 Monitoring: Surveys and interviews with enrolled participants
Enrollment Rate	39 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of one year

Population: Number of patients completed at least 80% of the electronic patient reported outcomes survey

Patient adherence to electronic patient reported outcomes

Outcome measures

Outcome measures
Measure	Pilot n=39 Participants 39 eligible HF patients Non-invasive continuous remote monitoring with structured escalation pathway: 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 Monitoring: Surveys and interviews with enrolled participants
Adherence Rate	27 Participants

SECONDARY outcome

Timeframe: 30 days from patient discharge date

Number of patients on escalated diuretics dosage by the clinical care team during monitoring period

Outcome measures

Outcome measures
Measure	Pilot n=39 Participants 39 eligible HF patients Non-invasive continuous remote monitoring with structured escalation pathway: 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 Monitoring: Surveys and interviews with enrolled participants
Documented Diuretic Escalation	17 Participants

SECONDARY outcome

Timeframe: 30 days from patient discharge date

30-day readmission rate from the day of discharge

Outcome measures

Outcome measures
Measure	Pilot n=39 Participants 39 eligible HF patients Non-invasive continuous remote monitoring with structured escalation pathway: 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 Monitoring: Surveys and interviews with enrolled participants
30-day Readmission Rate	6 Participants

Adverse Events

Pilot - 39 Eligible HF Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nirav Shah

NorthShore University HealthSystem

Phone: 847-657-5959

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place