Age ProblemFRAILCIEDNCT03079726
Use of Device Data to Predict Frailty in Individuals
An observational study of Age Problem and Morality, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This is an investigation to examine the correlation and predictive ability of activity measures obtained from cardiovascular implantable electrical devices. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Age Problem, Morality, Arrhythmias, Cardiac
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2017to 1 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Individuals followed in the UCH device clinic
- Individuals with CIED implanted
- Age over 65
Who cannot join
- Unable/unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, Denver
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Changes in Daily Activity as measured with a Cardiovascular Implantable Electrical Device (CIED)
Daily activity adjudicated by CIED algorithm
Measured: 30 - 180 days
Presence of Cardiac arrhythmias
Any atrial or ventricular arrhythmia
Measured: From study onset until 2 years
Hospitalizations and Mortality
Any hospitalization or death
Measured: From study onset until 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start7 Sep 2017
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age ProblemStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Rosenberg, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079726
- Sponsor's protocol ID
- 16-2587
- Acronym
- FRAILCIED
- Status last verified
- Oct 2019
- First submitted
- 6 Mar 2017
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Plan for initial analysis; sharing if appropriate de-identification is determined possible by IRB and co-investigators
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Device Data to Predict Frailty in Individuals With Cardiovascular Implantable Electrical Devices: Pilot Study
- ClinicalTrials.gov ID
- NCT03079726
- Acronym / sponsor ID
- FRAILCIED / 16-2587
- Conditions
- Age Problem, Morality, Arrhythmias, Cardiac
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 14 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- Individuals followed in the UCH device clinic
- Individuals with CIED implanted
- Age over 65
Key exclusion criteria (1 listed)
- Unable/unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in Daily Activity as measured with a Cardiovascular Implantable Electrical Device (CIED)
Time frame: 30 - 180 days
Daily activity adjudicated by CIED algorithm
Presence of Cardiac arrhythmias
Time frame: From study onset until 2 years
Any atrial or ventricular arrhythmia
Hospitalizations and Mortality
Time frame: From study onset until 2 years
Any hospitalization or death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Individual participant dataSharing planned: Undecided. Plan for initial analysis; sharing if appropriate de-identification is determined possible by IRB and co-investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Rosenberg, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Problem and Morality, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Daily Activity as measured with a Cardiovascular Implantable Electrical Device (CIED) (time frame: 30 - 180 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.