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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03079726
Other study ID # 16-2587
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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