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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01975402

Acronym

R01-Aim2

Enrollment

Registered

2013-11-04

Start date

2013-11-30

Completion date

2019-03-31

Last updated

2019-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure

Keywords

Congestive Heart Failure

Brief summary

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

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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%

Design outcomes

Primary

Measure	Time frame	Description
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	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

Measure	Time frame	Description
effect of end-to-end system on life quality	12 months	Evaluation of end-to-end remote monitoring system in a less controlled environment by evaluating ease of use and clinical management.

Other

Measure	Time frame	Description
Healthcare record integration	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.

Countries

United States

Outcome results