This trial is active, not recruiting.

Condition congestive heart failure
Sponsor Preventice
Collaborator Mayo Clinic
Start date November 2013
End date August 2015
Trial size 30 participants
Trial identifier NCT01975402, 13-005607, R01 AGO41676


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

adherence and utilization of end-to-end system in 30 subjects with stable NYHA class I-III HF for 2 weeks
time frame: 12 months

Secondary Outcomes

effect of end-to-end system on life quality
time frame: 12 months

Eligibility Criteria

Male or female participants at least 50 years old.

Inclusion Criteria: - Outpatients - Stable NYHA 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 < 1 year - 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 EF of >40%

Additional Information

Official title Evaluation of the BodyGuardian End-to-end Remote Monitoring Platform in an Outpatient Heart Failure Population
Principal investigator Lyle J Olson, MD
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 HF 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Preventice.