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Use of Device Data to Predict Frailty in Individuals

Use of Device Data to Predict Frailty in Individuals With Cardiovascular Implantable Electrical Devices: Pilot Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03079726
Acronym
FRAILCIED
Enrollment
50
Registered
2017-03-14
Start date
2017-09-07
Completion date
2018-03-01
Last updated
2019-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age Problem, Arrhythmias, Cardiac, Morality

Brief summary

This is an investigation to examine the correlation and predictive ability of activity measures obtained from cardiovascular implantable electrical devices.

Detailed description

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.

Interventions

None listed

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Individuals followed in the UCH device clinic * Individuals with CIED implanted * Age over 65

Exclusion criteria

* Unable/unwilling to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Changes in Daily Activity as measured with a Cardiovascular Implantable Electrical Device (CIED)30 - 180 daysDaily activity adjudicated by CIED algorithm
Presence of Cardiac arrhythmiasFrom study onset until 2 yearsAny atrial or ventricular arrhythmia
Hospitalizations and MortalityFrom study onset until 2 yearsAny hospitalization or death

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026