Assessment of the BodyGuardian Remote Monitoring Platform in Elderly Healthy Subjects

Completed

• Conditions: Congestive Heart Failure
• Interventions: Device: BodyGuardian remote health monitoring system

• Registration Number: NCT01808053
• Lead Sponsor: Mayo Clinic

Brief 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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-07
• Study First Submitted QC: 2013-03-07
• Study First Posted: 2013-03-08
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-06
• Last Update Posted: 2014-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Resident at independent living facility
• Adequate phone service
• Healthy with life anticipated survival >than one year

Exclusion Criteria

• Skin reaction/allergies to adhesives
• Have implantable pacemaker and/or defibrillator or have a bed partner with an implantable pacemaker

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy older and independently living adults	BodyGuardian remote health monitoring system	The BodyGuardian remote health monitoring system will used by healthy older and independently living adults

Primary Outcome Measures

Name	Time	Method
Number of subjects with successful data transfer at the end of 30 day monitoring period.	approximately at the end of 30 day monitoring period	Data collected will be reviewed by engineering collaborators.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States