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Assessment of the BodyGuardian Remote Monitoring Platform in Elderly Healthy Subjects

This study has been completed.
Sponsor:
Collaborators:
Preventice
Information provided by (Responsible Party):
Charles J. Bruce, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01808053
First received: March 7, 2013
Last updated: January 6, 2014
Last verified: January 2014

March 7, 2013
January 6, 2014
March 2013
December 2013   (final data collection date for primary outcome measure)
Number of subjects with successful data transfer at the end of 30 day monitoring period. [ Time Frame: approximately at the end of 30 day monitoring period ] [ Designated as safety issue: No ]
Data collected will be reviewed by engineering collaborators.
Same as current
Complete list of historical versions of study NCT01808053 on ClinicalTrials.gov Archive Site
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Assessment of the BodyGuardian Remote Monitoring Platform in Elderly Healthy Subjects
Assessment of the BodyGuardian Remote Monitoring Platform in Elderly Healthy Subjects

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Healthy older adults living at an independent living center.

Congestive Heart Failure
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.
Healthy older and independently living adults
The BodyGuardian remote health monitoring system will used by healthy older and independently living adults
Intervention: Device: BodyGuardian remote health monitoring system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01808053
12-008639, R01AG041676
No
Charles J. Bruce, Mayo Clinic
Mayo Clinic
  • National Institutes of Health (NIH)
  • National Institute on Aging (NIA)
  • Preventice
Principal Investigator: Charles J Bruce, MBChB Mayo Clinic
Mayo Clinic
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP