Assessment of the BodyGuardian Remote Monitoring Platform in Elderly Healthy Subjects
2 other identifiers
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 7, 2013
CompletedFirst Posted
Study publicly available on registry
March 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 7, 2014
January 1, 2014
9 months
March 7, 2013
January 6, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Healthy older and independently living adults
The BodyGuardian remote health monitoring system will used by healthy older and independently living adults
Interventions
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.
Eligibility Criteria
Healthy older adults living at an independent living center.
You may qualify if:
- Resident at independent living facility
- Adequate phone service
- Healthy with life anticipated survival \>than one year
You may not qualify if:
- Skin reaction/allergies to adhesives
- Have implantable pacemaker and/or defibrillator or have a bed partner with an implantable pacemaker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Institutes of Health (NIH)collaborator
- National Institute on Aging (NIA)collaborator
- Preventicecollaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles J Bruce, MBChB
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 7, 2013
First Posted
March 8, 2013
Study Start
March 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
January 7, 2014
Record last verified: 2014-01