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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2019-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Congestive Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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%

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No