Trial Outcomes & Findings for The Cascade Feasibility Pilot (Ileostomy) (NCT NCT05048329)

NCT ID: NCT05048329

Last Updated: 2024-05-21

Results Overview

Drop out from study

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: 30 days from patient discharge date
• Results posted on: 2024-05-21

Participant Flow

Recruitment was conducted at three NorthShore Hospitals from August 2021 and September 2022

A total of 11 participants were enrolled in the study. One patient withdrew and one was a screen fail, resulting in a total of 9 participants who completed the study.

Participant milestones

Measure	Ileostomy Cohort The study will include 10 eligible patients into the study cohort to conduct the study.
Overall Study STARTED	11
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Ileostomy Cohort The study will include 10 eligible patients into the study cohort to conduct the study.
Overall Study Withdrawal by Subject	1
Overall Study Screenfail	1

Baseline Characteristics

The Cascade Feasibility Pilot (Ileostomy)

Baseline characteristics by cohort

Measure	Ileostomy Cohort n=9 Participants The study will include ten eligible patients into the cohort to conduct 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 colorectal clinical team Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Surveys and interviews with enrolled participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days from patient discharge date

Drop out from study

Outcome measures

Measure

Ileostomy Cohort n=11 Participants The study will include ten eligible patients into the cohort to conduct 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 colorectal clinical team Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Surveys and interviews with enrolled participants

Attrition Rate

2 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 30 days for each patient

Enrollment rate for entire patient cohort

Outcome measures

Measure

Ileostomy Cohort n=23 Participants The study will include ten eligible patients into the cohort to conduct 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 colorectal clinical team Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Surveys and interviews with enrolled participants

Enrollment Rate

11 Participants

SECONDARY outcome

Timeframe: 30 days from patient discharge date

30-day readmission to hospital

Outcome measures

Measure

Ileostomy Cohort n=9 Participants The study will include ten eligible patients into the cohort to conduct 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 colorectal clinical team Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Surveys and interviews with enrolled participants

30 Days Readmission

1 Participants

SECONDARY outcome

Timeframe: 30 days from patient discharge date

Frequency of stool regimen escalation by providers

Outcome measures

Measure

Ileostomy Cohort n=9 Participants The study will include ten eligible patients into the cohort to conduct 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 colorectal clinical team Affective Analysis of Participant Response to Continuous Remote Patient Monitoring: Surveys and interviews with enrolled participants

Number of Participants With Stool Regimen Escalation

2 Participants

Adverse Events

Ileostomy Cohort

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 S Shah

NorthShore university HealthSystem

Phone: 847-570-3542

Email: nshah@northshore.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place