Assessment of the BodyGuardian Remote Monitoring Platform in Elderly Healthy Subjects

Congestive Heart Failure Clinical Trial

Official title:

Assessment of the BodyGuardian Remote Monitoring Platform in Elderly Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01808053
• Other study ID #: 12-008639
• Secondary ID: R01AG041676
• Status: Completed
• Phase: N/A
• First received: March 7, 2013
• Last updated: January 6, 2014
• Start date: March 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• BodyGuardian remote health monitoring system
The 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute on Aging (NIA), National Institutes of Health (NIH), Preventice

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with successful data transfer at the end of 30 day monitoring period.	Data collected will be reviewed by engineering collaborators.	approximately at the end of 30 day monitoring period	No