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OpenTrials
Completed

NCT Number: NCT01975402

Evaluation of the BodyGuardian End-to-end Remote Monitoring Platform in an Outpatient Heart Failure Population

We will evaluate the end to end remote monitoring system in a less controlled environment and concurrently develop the infrastructure to support the back end of the system

Completed

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Jacksonville, Florida, United States

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About this study

The overall objective of our research is to test, adapt, refine and validate the BodyGuardian technology and related end-to-end remote monitoring system to be used outside usual medical care environments to reduce hospital readmissions and facilitate independent living for heart failure patients. An important component of our overall strategy for continued development and refinement of the remote monitoring system is the incorporation of iterative behavioral evaluations to facilitate assessment and refinement in order to optimize adherence, utilization, and usability for patients as well as efficiency and functionality for providers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatients
  • Stable New York Heart Association Class I-III HF (defined as no admissions for > 1 year)
  • Recruited from the Mayo Heart Failure Clinic, including 15 men and 15 women
  • Age > 50 years
  • Reside in Olmsted County

Exclusion criteria

  • Hospital admission for HF within past year
  • Dementia
  • Overall life expectancy < 2 months
  • Blindness
  • Pregnancy or women able to become pregnant
  • Skin allergy to adhesives
  • Inadequate cell phone coverage (international patients or international travel during study period)
  • Documented Ejection Fraction of >40%

Treatment and study plan

Primary outcomes

  1. adherence and utilization of end-to-end system in 30 subjects with stable New York Heart Association class I-III Heart Failure for 2 weeks

    Time frame: 12 months

    To evaluate subject adherence, data transfer, clinical utilization and work-flow as well as perceptions and experiences of HF outpatients (n=30) and providers of the end-to-end remote monitoring system.

Secondary outcomes

  1. effect of end-to-end system on life quality

    Time frame: 12 months

    Evaluation of end-to-end remote monitoring system in a less controlled environment by evaluating ease of use and clinical management.

Other outcomes

  1. Healthcare record integration

    Time frame: 12 months

    Concurrently develop the infrastructure to support the back-end solution of the system including technician support, closed feedback loops to support care of the monitored subjects by an integrated team of health care providers, user-interfaces which display summarized data for the patient and other members of the healthcare team, and integration of summarized data into the Mayo electronic medical record.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute on Aging (NIA)
  • Preventice

Registry information

Acronym: R01-Aim2

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Nov 4, 2013
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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