Use of Device Data to Predict Frailty in Individuals

Arrhythmias, Cardiac Clinical Trial

— FRAILCIED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03079726
• Other study ID #: 16-2587
• Status: Completed
• Start date: September 7, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: October 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Individuals followed in the UCH device clinic

• Individuals with CIED implanted

• Age over 65

Exclusion Criteria:

• Unable/unwilling to provide informed consent

Related Conditions & MeSH terms

• Age Problem
• Arrhythmias, Cardiac
• Frailty
• Morality

Locations

Country	Name	City	State
United States	University of Colorado, Denver	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

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