Assessment of the BodyGuardian Remote Monitoring Platform in Elderly Healthy Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Healthy older and independently living adults The BodyGuardian remote health monitoring system will used by healthy older and independently living adults |
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.
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
- National Institutes of Health (NIH)
- National Institute on Aging (NIA)
- Preventice
Investigators
- Principal Investigator: Charles J Bruce, MBChB, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 12-008639
- R01AG041676