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Behavioural Intervention
Non-invasive continuous remote monitoring with structured escalation pathway for Heart Failure
N/A
Waitlist Available
Led By Nirav S Shah
Research Sponsored by NorthShore University HealthSystem
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average 1 year
Awards & highlights
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence rate
Attrition rate
Enrollment rate
+1 moreSecondary outcome measures
30-day readmission rate
Average number of clinical alerts from wearable platform
Documented Dietary counseling
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: PilotExperimental Treatment2 Interventions
45 eligible HF patients
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Who is running the clinical trial?
NorthShore University HealthSystemLead Sponsor
132 Previous Clinical Trials
737,598 Total Patients Enrolled
1 Trials studying Heart Failure
20 Patients Enrolled for Heart Failure
Nirav S ShahPrincipal InvestigatorNorthShore University HealthSystem
1 Previous Clinical Trials
11 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have skin damage that makes it impossible to wear the study device.You have kidney problems that require dialysis.You are pregnant.You are currently under hospice care.You are allergic to hydrocolloid adhesives.You have a device called CardioMEMS implanted in your body.You have had heart failure in the past.You have symptoms that match with NYHA function class II-IV.You have trouble seeing.
Research Study Groups:
This trial has the following groups:- Group 1: Pilot
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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