Use of Device Data to Predict Frailty in Individuals

Completed

• Conditions: Morality; Arrhythmias, Cardiac; Age Problem

• Registration Number: NCT03079726
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-13
• Study First Posted: 2017-03-14
• Study Start: 2017-09-07
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• Unable/unwilling to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in Daily Activity as measured with a Cardiovascular Implantable Electrical Device (CIED)	30 - 180 days	Daily activity adjudicated by CIED algorithm
Presence of Cardiac arrhythmias	From study onset until 2 years	Any atrial or ventricular arrhythmia
Hospitalizations and Mortality	From study onset until 2 years	Any hospitalization or death

Trial Locations

Locations (1)

University of Colorado, Denver; 🇺🇸 Aurora, Colorado, United States