Use of Device Data to Predict Frailty in Individuals (FRAILCIED)

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

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

Study Overview

• Status: Completed
• Conditions: Arrhythmias, Cardiac; Age Problem; Morality

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado, Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Frail individuals (case); Individuals classified as frail based on several clinical metrics
Non-frail individuals; Individuals failing to meet criteria for frailty based on clinical metrics

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Michael Rosenberg, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 14, 2017

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Frailty; Arrhythmias, Cardiac
• Other Study ID Numbers: 16-2587

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Plan for initial analysis; sharing if appropriate de-identification is determined possible by IRB and co-investigators

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No