Non-invasive continuous remote monitoring with structured escalation pathway for Heart Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
NorthShore University HealthSystem Evanston Hospital, Evanston, ILHeart FailureNon-invasive continuous remote monitoring with structured escalation pathway - Other
Eligibility
18 - 100
All Sexes
What conditions do you have?
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Study Summary

This trial will test a new way of monitoring heart failure patients using a wearable device that sends data to a remote team of health care providers. The goal is to improve patient outcomes by catching problems early and promoting self-care.

Treatment Effectiveness

Study Objectives

4 Primary · 5 Secondary · Reporting Duration: Through study completion, an average 1 year

Day 30
30-day readmission rate
Average number of clinical alerts from wearable platform
Documented Dietary counseling
Documented Diuretic Escalation
Documented Medication adherence counseling
Day 30
Time from discharge to first non-adherence event
Year 1
Adherence rate
Attrition rate
Enrollment rate

Trial Safety

Trial Design

2 Treatment Groups

Soft Launch
1 of 2
Pilot
1 of 2

Experimental Treatment

45 Total Participants · 2 Treatment Groups

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

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
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

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average 1 year

Who is running the clinical trial?

NorthShore University HealthSystemLead Sponsor
113 Previous Clinical Trials
735,027 Total Patients Enrolled
1 Trials studying Heart Failure
20 Patients Enrolled for Heart Failure
Nirav S ShahPrincipal InvestigatorNorthShore University HealthSystem
1 Previous Clinical Trials
55 Total Patients Enrolled

Eligibility Criteria

Age 18 - 100 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have symptoms that match with NYHA function class II-IV.

Frequently Asked Questions

What is the desired outcome of this research?

"Over the course of one year, this clinical trial aims to assess the average rate of patient enrollment. There are also three secondary outcomes that will be evaluated: frequency of medication adherence counseling captured in a note within the electronic health record, dietary counseling noted in a similar manner and number of times standard diuretics dosage were escalated clinically." - Anonymous Online Contributor

Unverified Answer

How many participants are being accepted for this research?

"Affirmative. The information featured on clinicaltrials.gov reveals that this investigation is actively seeking participants, which initially began recruiting on June 17th 2021 and has since been updated on January 11th 2022. Currently, 45 subjects are required from one site for the study to be considered complete." - Anonymous Online Contributor

Unverified Answer

Are there currently any vacancies available in this experiment?

"According to information provided on clinicaltrials.gov, this experiment is open for recruitment and was first announced on June 17th 2021 (last edited: January 11th 2022)." - Anonymous Online Contributor

Unverified Answer

Would I be eligible to join this medical experiment?

"This clinical trial is seeking 45 individuals aged 18 to 100 who are currently suffering from heart failure. Qualified participants must have received at least one dose of intravenous diuretic medication during their hospitalisation, be inpatients at Evanston Hospital, regularly follow up with the Heart Failure Service Team after discharge, possess a historical record of heart failure symptoms corresponding to NYHA function class II-IV and meet either criteria A (LVEF < 40%), B (40% ≤ LVEF ≤ 50%) or C (50% ≤ LVEF), occupy the top half percentile for 30-day readmission risk as calculated by North" - Anonymous Online Contributor

Unverified Answer

Are seniors able to partake in this experimental procedure?

"This trial is intended for patients aged 18 to 100 years old. Additionally, there are 22 trials for minors and 691 studies specifically designed for individuals 65 or older." - 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.