Use of Device Data to Predict Frailty in Individuals

NCT ID: NCT03079726

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-07
• Study Completion Date: 2018-03-01

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.

Conditions

Age Problem; Morality; Arrhythmias, Cardiac

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Frail individuals (case)

Individuals classified as frail based on several clinical metrics

No interventions assigned to this group

Non-frail individuals

Individuals failing to meet criteria for frailty based on clinical metrics

No interventions assigned to this group

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Rosenberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado, Denver

Aurora, Colorado, United States

Countries

United States

Other Identifiers

16-2587

Identifier Type: -

Identifier Source: org_study_id