Clinical Trials Directory

Trials / Completed

CompletedNCT01808053

Assessment of the BodyGuardian Remote Monitoring Platform in Elderly Healthy Subjects

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Accepted

Summary

To adapt and refine the BodyGuardian remote health monitoring system to acquire ECG, Heart rate (HR), activity and breathing data, which will be integrated with weight, blood pressure and symptom data, in subjects in an independent living center, with wireless transmission of data to a central data analysis hub.

Detailed description

The elderly are facing an increasing prevalence of chronic disease and rapidly escalating healthcare costs threatening independent living. Congestive heart failure (CHF) is a growing health epidemic and is associated with significant morbidity, mortality and cost. Mayo Clinic and Preventice have developed a non-invasive, minimally obtrusive, interactive remote monitoring platform. It enables on-body monitoring and integration of ECG, heart rate, breathing, and activity, with measures of weight and blood pressure. It is designed as a platform for physician directed patient self-management. This technology may be useful in monitoring CHF patients. Our overall objective is to adapt, refine, test and validate this technology in subjects in an independent living center, with wireless transmission of data to a central data analysis hub.

Conditions

Interventions

TypeNameDescription
DEVICEBodyGuardian remote health monitoring systemThe remote health management system connects personal health sensors with secure mobile communication devices. It is also able to give immediate feedback to the user. The solution is a multi-tiered mobile health platform. The front-end includes an adhesive snap-strip body sensor (BodyGuardian) that can measure HR, ECG, respiration rate (RR), and activity which is FDA approved for detection of non-lethal cardiac arrhythmias. It can wirelessly communicate with off-body sensors such as a BP cuff and scale to incorporate BP and weight data based on automated algorithms and can solicit symptoms from the user. It can also be used as an event recorder inputting symptoms and recording simultaneous physiologic data.

Timeline

Start date
2013-03-01
Primary completion
2013-12-01
Completion
2013-12-01
First posted
2013-03-08
Last updated
2014-01-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01808053. Inclusion in this directory is not an endorsement.