An observational study in Congestive Heart Failure, sponsored by Mayo Clinic. Completed at 3 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-05-21.
Sponsored by Mayo Clinic · Observational
We will evaluate the end to end remote monitoring system in a less controlled environment and concurrently develop the infrastructure to support the back end of the system
The overall objective of our research is to test, adapt, refine and validate the BodyGuardian technology and related end-to-end remote monitoring system to be used outside usual medical care environments to reduce hospital readmissions and facilitate independent living for heart failure patients. An important component of our overall strategy for continued development and refinement of the remote monitoring system is the incorporation of iterative behavioral evaluations to facilitate assessment and refinement in order to optimize adherence, utilization, and usability for patients as well as efficiency and functionality for providers.
5,701 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's enrollment of 42 is below the median of 200 across 1,678 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Individuals >50 years with Congestive Heart Failure
Exclusion Criteria:
adherence and utilization of end-to-end system in 30 subjects with stable New York Heart Association class I-III Heart Failure for 2 weeks
To evaluate subject adherence, data transfer, clinical utilization and work-flow as well as perceptions and experiences of HF outpatients (n=30) and providers of the end-to-end remote monitoring system.
Time frame: 12 months
effect of end-to-end system on life quality
Evaluation of end-to-end remote monitoring system in a less controlled environment by evaluating ease of use and clinical management.
Time frame: 12 months
Healthcare record integration
Concurrently develop the infrastructure to support the back-end solution of the system including technician support, closed feedback loops to support care of the monitored subjects by an integrated team of health care providers, user-interfaces which display summarized data for the patient and other members of the healthcare team, and integration of summarized data into the Mayo electronic medical record.
Time frame: 12 months
Plan to share: No
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mayo Clinic