REducing 30-day ADMIssions in posT-discharge Subjects (READMIT)
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/31/2018 |
Start Date: | April 2012 |
End Date: | August 2013 |
Observational Study of Reducing 30-day Admissions in Post-discharge Subjects
The purpose of this observational study is to collect and characterize multiple physiologic
data from a broad subset of subjects with acute heart failure (HF)
Changes in physiologic data are expected to correlate with 30-day readmission rates in this
population
data from a broad subset of subjects with acute heart failure (HF)
Changes in physiologic data are expected to correlate with 30-day readmission rates in this
population
This is a multi-center, non-randomized feasibility study aimed at obtaining data from
systolic and diastolic HF subjects in the hospital, with continued monitoring using an
external wearable monitor for up to 4 weeks post-hospital-discharge. Data will be collected
during the hospital stay and at in office follow-up visits at 1 week and 1 month
post-hospital discharge
The data will help generate hypotheses and aid in determining whether development of a
detection algorithm for acute heart failure decompensation is feasible. Due to the
feasibility nature of this study there is no minimum required sample size but it is
anticipated that the study will enroll up to 100 subjects from seven (7) study sites in the
United States and one (1) study site in Australia
The study objectives are:
- Collect and characterize physiologic data from subjects with acute decompensated heart
failure.
- Characterization of data related to health care utilizations within 30-days
Post-discharge
- Correlation between patch monitor collected data and inpatient clinical data
- Correlation between patch monitor data and other clinical data collected after patient
discharge (30-60 days)
systolic and diastolic HF subjects in the hospital, with continued monitoring using an
external wearable monitor for up to 4 weeks post-hospital-discharge. Data will be collected
during the hospital stay and at in office follow-up visits at 1 week and 1 month
post-hospital discharge
The data will help generate hypotheses and aid in determining whether development of a
detection algorithm for acute heart failure decompensation is feasible. Due to the
feasibility nature of this study there is no minimum required sample size but it is
anticipated that the study will enroll up to 100 subjects from seven (7) study sites in the
United States and one (1) study site in Australia
The study objectives are:
- Collect and characterize physiologic data from subjects with acute decompensated heart
failure.
- Characterization of data related to health care utilizations within 30-days
Post-discharge
- Correlation between patch monitor collected data and inpatient clinical data
- Correlation between patch monitor data and other clinical data collected after patient
discharge (30-60 days)
Inclusion Criteria:
- Subject with acute decompensated heart failure
- Subject (or legal guardian) willing to give consent for their participation
- Subject ≥18 years of age
Exclusion Criteria:
- Subject who is expected to receive a heart transplant or a ventricular assist device
within 6 months
- Subject who cannot tolerate placement of external patch monitor on chest in the
proposed location (ECG Lead II orientation)
- Subject with known allergies or hypersensitivities to adhesives or hydrogels
- Subject with implantable devices with active minute ventilation sensors.
- Subject who will not comply to study protocol requirements. This includes completing
required data collection, and attending required follow up study visits.
We found this trial at
8
sites
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
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Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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