Clinical trial NCT03079726: Use of Device Data to Predict Frailty in Individuals
Official title: Use of Device Data to Predict Frailty in Individuals With Cardiovascular Implantable Electrical Devices: Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Problem
Morality
Arrhythmias, Cardiac
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-03-14
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators plan to enroll all individuals followed in the UCH device clinic, in whom CIED data is available for analysis who are over age 65, and willing and able to provide informed consent. We will not a priori exclude individuals unable to take part in the walk-time, survey/questionnaire assessment, or mini-Cog assessment, although these individuals may be excluded during analysis.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Unable/unwilling to provide informed consent

Primary outcomes:
measure: Changes in Daily Activity as measured with a Cardiovascular Implantable Electrical Device (CIED)
timeFrame: 30 - 180 days
measure: Presence of Cardiac arrhythmias
timeFrame: From study onset until 2 years
measure: Hospitalizations and Mortality
timeFrame: From study onset until 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado, Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Michael Rosenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: