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

Completed

• Conditions: Congestive Heart Failure

• Registration Number: NCT01975402
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2013-10-23
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-01
• Study First Posted: 2013-11-03
• Primary Completion: 2019-03-31
• Study Completion: 2019-03-31
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-20
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic Health System-Franciscan Medical Center; 🇺🇸 La Crosse, Wisconsin, United States

Mayo Clinic Health System-Eau Claire Hospital, Inc.; 🇺🇸 Eau Claire, Wisconsin, United States