Trial Outcomes & Findings for The CASCADE HF Soft Launch and Calibration Phase I and II (NCT NCT04738279)
NCT ID: NCT04738279
Last Updated: 2023-10-03
Results Overview
Drop out from study
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
20 participants
Primary outcome timeframe
30 days from patient discharge date
Results posted on
2023-10-03
Participant Flow
Recruitment was conducted at Evanston Hospital during December 2020 to October 2021
Participant milestones
| Measure |
Phase I: Soft Launch (120 Days)
The study will conduct a soft launch on the first five HF patients enrolled to finetune process and protocol.
Non-Invasive Continuous Remote Patient Monitoring: Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway
Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Survey and qualitative interviewing of participants
|
Phase II: Calibration (210 Days)
After learning from the soft launch and updating the protocol, the study will continue to enroll 15 HF patients for calibration purposes
Non-Invasive Continuous Remote Patient Monitoring: Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway
Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Survey and qualitative interviewing of participants
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
15
|
|
Overall Study
COMPLETED
|
4
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The CASCADE HF Soft Launch and Calibration Phase I and II
Baseline characteristics by cohort
| Measure |
Phase I: Soft Launch (120 Days)
n=5 Participants
The study will conduct a soft launch on the first five HF patients enrolled to finetune process and protocol.
Non-Invasive Continuous Remote Patient Monitoring: Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway
Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Survey and qualitative interviewing of participants
|
Phase II: Calibration (210 Days)
n=15 Participants
After learning from the soft launch and updating the protocol, the study will continue to enroll 15 HF patients for calibration purposes
Non-Invasive Continuous Remote Patient Monitoring: Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway
Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Survey and qualitative interviewing of participants
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days from patient discharge dateDrop out from study
Outcome measures
| Measure |
Phase I: Soft Launch (120 Days)
n=5 Participants
The study will conduct a soft launch on the first five HF patients enrolled to finetune process and protocol.
Non-Invasive Continuous Remote Patient Monitoring: Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway
Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Survey and qualitative interviewing of participants
|
Phase II: Calibration (210 Days)
n=15 Participants
After learning from the soft launch and updating the protocol, the study will continue to enroll 15 HF patients for calibration purposes
Non-Invasive Continuous Remote Patient Monitoring: Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway
Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Survey and qualitative interviewing of participants
|
|---|---|---|
|
Attrition Rate
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 30 days for each patientPopulation: Overall number of participants analyzed reflects the number of participants who were screened for phase I and phase II, respectively.
Enrollment rate for entire patient cohort
Outcome measures
| Measure |
Phase I: Soft Launch (120 Days)
n=43 Participants
The study will conduct a soft launch on the first five HF patients enrolled to finetune process and protocol.
Non-Invasive Continuous Remote Patient Monitoring: Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway
Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Survey and qualitative interviewing of participants
|
Phase II: Calibration (210 Days)
n=431 Participants
After learning from the soft launch and updating the protocol, the study will continue to enroll 15 HF patients for calibration purposes
Non-Invasive Continuous Remote Patient Monitoring: Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway
Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Survey and qualitative interviewing of participants
|
|---|---|---|
|
Enrollment Rate
|
5 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 30 days from patient discharge dateFrequency of augmenting diuretic dosage as prescribed by the cardiologist to the patient.
Outcome measures
| Measure |
Phase I: Soft Launch (120 Days)
n=5 Participants
The study will conduct a soft launch on the first five HF patients enrolled to finetune process and protocol.
Non-Invasive Continuous Remote Patient Monitoring: Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway
Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Survey and qualitative interviewing of participants
|
Phase II: Calibration (210 Days)
n=15 Participants
After learning from the soft launch and updating the protocol, the study will continue to enroll 15 HF patients for calibration purposes
Non-Invasive Continuous Remote Patient Monitoring: Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway
Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Survey and qualitative interviewing of participants
|
|---|---|---|
|
Number of Participants With Diuretic Escalation
|
2 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 30 days from patient discharge date30-day readmission to hospital
Outcome measures
| Measure |
Phase I: Soft Launch (120 Days)
n=5 Participants
The study will conduct a soft launch on the first five HF patients enrolled to finetune process and protocol.
Non-Invasive Continuous Remote Patient Monitoring: Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway
Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Survey and qualitative interviewing of participants
|
Phase II: Calibration (210 Days)
n=15 Participants
After learning from the soft launch and updating the protocol, the study will continue to enroll 15 HF patients for calibration purposes
Non-Invasive Continuous Remote Patient Monitoring: Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway
Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Survey and qualitative interviewing of participants
|
|---|---|---|
|
30-day Readmission
|
2 Participants
|
2 Participants
|
Adverse Events
Phase I: Soft Launch (120 Days)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase II: Calibration (210 Days)
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
Nirav Shah, MD, MPH
NorthShore University HealthSystem
Phone: (847) 570-1236
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place