Evaluation of the BodyGuardian End-to-end Remote Monitoring Platform in an Outpatient Heart Failure Population



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:50 - Any
Updated:3/22/2019
Start Date:November 2013
End Date:April 2019

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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.

Inclusion Criteria:

- Outpatients

- Stable New York Heart Association Class I-III HF (defined as no admissions for > 1
year)

- Recruited from the Mayo Heart Failure Clinic, including 15 men and 15 women

- Age > 50 years

- Reside in Olmsted County

Exclusion Criteria:

- Hospital admission for HF within past year

- Dementia

- Overall life expectancy < 2 months

- Blindness

- Pregnancy or women able to become pregnant

- Skin allergy to adhesives

- Inadequate cell phone coverage (international patients or international travel during
study period)

- Documented Ejection Fraction of >40%
We found this trial at
3
sites
700 West Avenue South
La Crosse, Wisconsin 54601
Principal Investigator: Charles Cagin, MD
Phone: 608-392-6880
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Principal Investigator: Mohamad Yamani, MD
Phone: 904-953-3882
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Eau Claire, Wisconsin 54702
Principal Investigator: Fearghas O'Cochlain, MD
Phone: 715-464-8172
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Eau Claire, WI
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