Evaluation of the BodyGuardian End-to-end Remote Monitoring Platform in an Outpatient Heart Failure Population
R01-Aim2
2 other identifiers
observational
42
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2013
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedFirst Posted
Study publicly available on registry
November 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2019
CompletedMay 21, 2019
May 1, 2019
5.4 years
October 23, 2013
May 20, 2019
Conditions
Keywords
Outcome Measures
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
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 Outcomes (1)
effect of end-to-end system on life quality
12 months
Other Outcomes (1)
Healthcare record integration
12 months
Eligibility Criteria
Individuals \>50 years with Congestive Heart Failure
You may qualify if:
- 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
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Preventicecollaborator
- National Institute on Aging (NIA)collaborator
Study Sites (3)
Mayo Clinic
Jacksonville, Florida, 32224, United States
Mayo Clinic Health System-Eau Claire Hospital, Inc.
Eau Claire, Wisconsin, 54702, United States
Mayo Clinic Health System-Franciscan Medical Center
La Crosse, Wisconsin, 54601, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lyle J Olson, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
October 23, 2013
First Posted
November 4, 2013
Study Start
November 1, 2013
Primary Completion
March 31, 2019
Study Completion
March 31, 2019
Last Updated
May 21, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share