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

Congestive Heart Failure Clinical Trial

— R01-Aim2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01975402
• Other study ID #: 13-005607
• Secondary ID: R01AG041676
• Status: Completed
• Start date: November 2013
• Est. completion date: March 31, 2019

Study information

• Verified date: May 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Locations

Country	Name	City	State
United States	Mayo Clinic Health System-Eau Claire Hospital, Inc.	Eau Claire	Wisconsin
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic Health System-Franciscan Medical Center	La Crosse	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute on Aging (NIA), Preventice

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Healthcare record integration	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.	12 months
Primary	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	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.	12 months
Secondary	effect of end-to-end system on life quality	Evaluation of end-to-end remote monitoring system in a less controlled environment by evaluating ease of use and clinical management.	12 months

External Links

•   Mayo Clinic Clinical Trials