Non-invasive continuous remote monitoring with structured escalation pathway for Ileostomy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
NorthShore University HealthSystem HighlandPark Hospital, Highland Park, ILIleostomy+1 MoreNon-invasive continuous remote monitoring with structured escalation pathway - Other
Eligibility
18 - 100
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a wearable solution that predicts physiological problems and sends alerts to surgeons and nurses in order to improve care for patients after high-risk colorectal surgery.

Eligible Conditions
  • Ileostomy

Treatment Effectiveness

Study Objectives

3 Primary · 3 Secondary · Reporting Duration: Through study completion, an average 2 year

Day 30
Documented Dietary counseling
Documented Medication adherence counseling
Stool regimen escalation
Year 2
Adherence to study requirement rate
Attrition rate
Enrollment rate

Trial Safety

Trial Design

2 Treatment Groups

Pilot
1 of 2
Soft Launch
1 of 2

Experimental Treatment

55 Total Participants · 2 Treatment Groups

Primary Treatment: Non-invasive continuous remote monitoring with structured escalation pathway · No Placebo Group · N/A

PilotExperimental Group · 2 Interventions: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring, Non-invasive continuous remote monitoring with structured escalation pathway · Intervention Types: Other, Other
Soft LaunchExperimental Group · 2 Interventions: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring, Non-invasive continuous remote monitoring with structured escalation pathway · Intervention Types: Other, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average 2 year

Who is running the clinical trial?

NorthShore University HealthSystemLead Sponsor
113 Previous Clinical Trials
735,017 Total Patients Enrolled
Nirav S ShahPrincipal InvestigatorNorthShore University HealthSystem
1 Previous Clinical Trials
45 Total Patients Enrolled

Eligibility Criteria

Age 18 - 100 · All Participants · 6 Total Inclusion Criteria

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Frequently Asked Questions

Is this experiment in need of more participants?

"Affirmative. According to records published on clinicaltrials.gov, this research trial is actively recruiting participants; commencing enrollment on August 9th 2021 and revised lastly December 9th 2021. It specifies that it requires 55 individuals from 3 different medical locations." - Anonymous Online Contributor

Unverified Answer

Is this trial open to those aged seventy-five and above?

"This medical study requires participants to be aged between 18-100 years old. For those younger than 18, there is a separate trial and for adults over 65, there are 13 other studies available." - Anonymous Online Contributor

Unverified Answer

What is the maximum number of participants being included in this research?

"Affirmative. According to the details listed on clinicaltrials.gov, this scientific trial is actively sourcing participants since its inception on August 9th 2021 and most recent revision on December 9th 2021. With 55 individuals needed from 3 different medical centres, recruitment is currently underway." - Anonymous Online Contributor

Unverified Answer

Who meets the criteria for enrolling in this trial?

"This research seeks 55 individuals, between 18-100 years of age, with ileostomy complications. Participants must also have had a new ileostomy formation at their index hospitalization; be willing to complete protocol-mandated tasks and be an inpatient admission at NorthShore University HealthSystem hospital." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.