Evaluation of the BodyGuardian End-to-end Remote Monitoring Platform in an Outpatient Heart Failure Population (R01-Aim2)

Mayo Clinic

Status: Completed

Conditions: Congestive Heart Failure

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT01975402

R01AG041676 (U.S. NIH Grant/Contract)

13-005607

Details and patient eligibility

About

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

Full description

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.

Enrollment: 42 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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%