Completed

BodyGuardian Remote Monitoring Platform for Elderly Health Management

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Study Aim

This study aims to observe how well the BodyGuardian Remote Monitoring Platform works for elderly health management, specifically by monitoring the number of successful data transfers over a 30-day period.

What is being collected

Device Data

Collected from today forward - Prospective
Device
Who is being recruted

Cardiovascular Diseases

+ Heart Diseases

+ Heart Failure

Over 50 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: March 2013
See protocol details

Summary

Principal SponsorMayo Clinic
Last updated: January 7, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

The elderly are facing an increasing prevalence of chronic disease and rapidly escalating healthcare costs threatening independent living. Congestive heart failure (CHF) is a growing health epidemic and is associated with significant morbidity, mortality and cost. Mayo Clinic and Preventice have developed a non-invasive, minimally obtrusive, interactive remote monitoring platform. It enables on-body monitoring and integration of ECG, heart rate, breathing, and activity, with measures of weight and blood pressure. It is designed as a platform for physician directed patient self-management. This technology may be useful in monitoring CHF patients. Our overall objective is to adapt, refine, test and validate this technology in subjects in an independent living center, with wireless transmission of data to a central data analysis hub.

NCT01808053
Principal SponsorMayo Clinic
Last updated: January 7, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHeart Failure

Criteria

3 inclusion criteria required to participate
Adequate phone service

Healthy with life anticipated survival > than one year

Resident at independent living facility

2 exclusion criteria prevent from participating
Have implantable pacemaker and/or defibrillator or have a bed partner with an implantable pacemaker

Skin reaction/allergies to adhesives

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Mayo Clinic

Rochester, United StatesOpen Mayo Clinic in Google Maps
CompletedOne Study Center