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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
  Purpose

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 Intervention
Congestive Heart Failure
Device: BodyGuardian remote health monitoring system

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of the BodyGuardian Remote Monitoring Platform in Elderly Healthy Subjects

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: March 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy older adults living at an independent living center.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01808053

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Preventice
Investigators
Principal Investigator: Charles J Bruce, MBChB Mayo Clinic
  More Information

No publications provided

Responsible Party: Charles J. Bruce, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01808053     History of Changes
Other Study ID Numbers: 12-008639, R01AG041676
Study First Received: March 7, 2013
Last Updated: January 6, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 25, 2014