University of Colorado, Denver
Aurora, Colorado, 80045, United States
NCT Number: NCT03079726
This is an investigation to examine the correlation and predictive ability of activity measures obtained from cardiovascular implantable electrical devices.
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Notify Me65 year and older
All sexes
Observational
Aurora, Colorado, 80045, United States
Technology is providing new opportunities to gain insight into patient health in a manner far superior to what can be obtained from routine office visits. For geriatric patients, frailty is one such measure, which has been shown to have a negative correlation with outcomes, including hospitalizations, complications following invasive procedures, and overall mortality. Methods to quantify frailty have been highly limited and somewhat controversial, largely because of their cross-sectional nature. Efforts to obtain longitudinal measures of frailty using activity monitors and other wearable devices have been promising, although they are limited by patient cooperation and cost.
In addition to their therapeutic functions, cardiovascular implantable electrical devices (CIEDs) collect large amounts of data on individuals in whom they are implanted, which can be accessed during office visits as well as remotely. Importantly, the data is obtained passively and routinely from all patients, requiring little to no additional effort or expense. The possibility that activity measures from CIEDs could be used to evaluate frailty, as well as other outcomes, would provide a powerful tool for clinicians to apply data science directly to patients.
This pilot investigation will assess the feasibility of using CIED-derived activity data to predict frailty, and other outcomes, in older populations. The investigators plan to enroll subjects in whom CIEDs are implanted from the University of Colorado Hospital Device clinic, and analyze their data to assess the correlation of daily activity with frailty measures, as well as with cardiac and clinical outcomes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 30 - 180 days
Daily activity adjudicated by CIED algorithm
Time frame: From study onset until 2 years
Any atrial or ventricular arrhythmia
Time frame: From study onset until 2 years
Any hospitalization or death
University of Colorado, Denver
Other
Use of Device Data to Predict Frailty in Individuals With Cardiovascular Implantable Electrical Devices: Pilot Study
Acronym: FRAILCIED
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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