Assessment of the BodyGuardian Remote Monitoring Platform in Elderly Healthy Subjects

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of the BodyGuardian Remote Monitoring Platform in Elderly Healthy Subjects

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Device: BodyGuardian remote health monitoring system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy older and independently living adults<br>The BodyGuardian remote health monitoring system will used by healthy older and independently living adults | Device: BodyGuardian remote health monitoring system<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |