Evaluation of the HEMOTAG® system in a less controlled environment and concurrently develop the system for use by patients with heart failure.
The overall objective of research is to test, adapt, refine and validate the HEMOTAG® system to be used outside the usual medical care environments to reduce hospital readmissions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
420
Comparison of outcomes
Cleveland Clinic Florida
Weston, Florida, United States
RECRUITINGBaylor Scott & White Research Institute
Temple, Texas, United States
RECRUITINGThe number of recurrent HF readmissions. [Monitoring period: 30 days]
Determine if HEMOTAG can reduce the relative number of HF readmissions or ER visits versus standard of care. \[Monitoring period: 30 days from time of participant's discharge from initial index hospitalization\]
Time frame: 30 Days
Time from discharge until the first event of HF readmissions [Monitoring period: Event time assessed up to 3 months and 6 months from discharge.
Time from discharge to the first event of HF readmissions or ER visits \[Monitoring period: Event time assessed up to 3 months and 6 months from time of participant's discharge from initial study hospitalization.\]
Time frame: 6 Months
Number of total days lost to hospitalization due to HF events [Monitoring period: Expected average of 30 days, 3 months, 6 months]
Total number of total days lost to hospitalization or ER visit due to HF events \[Monitoring period: Expected average of 30 days, 3 months, 6 months from time of participant's discharge from index hospitalization.\]
Time frame: 6 Months
Time from discharge to all-cause mortality [Monitoring period: 30 days, 3 months,6 months]
Time from discharge to all-cause mortality \[Monitoring period: 30 days, 3 months,6 months from time of participant's discharge from initial study hospitalization.\]
Time frame: 6 Months
Skin irritation from HEMOTAG use [Time Frame: over the measurement period of 30 days] (Determine if subjects had skin irritation from use.)
Incidence of skin irritation \[Time Frame: over the measurement period of 30 days\] (Determine if subjects had skin irritation from use of device.)
Time frame: 30 Days
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