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REducing 30-day ADMIssions in posT-discharge Subjects (READMIT) (READMIT-HF)

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ClinicalTrials.gov Identifier: NCT01574144
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Tracking Information
First Submitted Date April 3, 2012
First Posted Date April 10, 2012
Results First Submitted Date February 12, 2014
Results First Posted Date October 29, 2018
Last Update Posted Date October 29, 2018
Study Start Date April 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 6, 2018)
Percentage of Participants With Health Care Utilizations [ Time Frame: 30 days post-discharge ]
Percentage of Participants with health care utilizations. Healthcare utilizations include hospitalizations, urgent care visits and emergency department visits.
Original Primary Outcome Measures
 (submitted: April 6, 2012)
Number of health care utilizations 30 days post-discharge [ Time Frame: 30 days post-discharge ]
Change History
Current Secondary Outcome Measures
 (submitted: February 6, 2018)
Change in Body Weight Per Unit Change in Thoracic Impedance [ Time Frame: Discharge to 30 days post discharge ]
Change in body weight per unit change in thoracic impedance. The regression coefficients between body weight and thoracic impedance.
Original Secondary Outcome Measures
 (submitted: April 6, 2012)
Change in impedance 30 days post-discharge [ Time Frame: 30 days post-discharge ]
Measures change in weight and tissue impedance throughout the monitoring period post-discharge
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title REducing 30-day ADMIssions in posT-discharge Subjects (READMIT)
Official Title Observational Study of Reducing 30-day Admissions in Post-discharge Subjects
Brief Summary

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

Detailed Description

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)
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Heart failure patients who are admitted to the hospital.
Condition Acute Decompensated Heart Failure
Intervention Device: AVIVO™ PiiX Patch Monitor System
External monitoring for 30 days post-discharge.
Study Groups/Cohorts AVIVO™ PiiX Patch Monitor System
Heart failure patients monitored continuously for 30 days post-discharge.
Intervention: Device: AVIVO™ PiiX Patch Monitor System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 22, 2013)
70
Original Estimated Enrollment
 (submitted: April 6, 2012)
100
Actual Study Completion Date August 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01574144
Other Study ID Numbers READMIT-HF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medtronic Cardiac Rhythm and Heart Failure
Study Sponsor Medtronic Cardiac Rhythm and Heart Failure
Collaborators Not Provided
Investigators
Study Director: READMIT-HF Study Team Medtronic
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date February 2018