Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03284203 |
| Other study ID # |
IRB17-0562 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 30, 2017 |
| Est. completion date |
March 1, 2018 |
Study information
| Verified date |
May 2023 |
| Source |
University of Chicago |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The investigators' central hypotheses predict that the handheld spirometry device will be
feasible for inpatient and at-home use, and is equally efficacious at determining lung
function when compared to traditional, bedside spirometry measurements. To test these
hypotheses, the investigators propose the following specific aims:
Specific Aim 1: Determine the correlation of SpiroPD handheld spirometry measurements with
bedside Koko spirometry lung function.
Hypothesis: Correlation between the two lung function tests will be substantial for both
hospitalized and ambulatory patients.
Specific Aim 2: To determine the feasibility, adherence, and preliminary management efficacy
of home SpiroPD testing.
Hypotheses: (1) Patients will demonstrate substantial adherence to daily home spirometry
testing; (2) medication adherence will increase significantly in patients who are adherent to
daily home spirometry testing; (3) acute care utilization will decrease significant in
adherent patients.
Description:
Chronic Obstructive Pulmonary Disease (COPD) results in nearly 750,000 hospitalizations
annually and is the third leading cause of "early" (within 30-day) hospital readmissions in
the United States. Curbing preventable early readmissions for acute exacerbations of COPD
(AECOPD) has become a national priority, as demonstrated by the Medicare Hospital
Readmissions Reduction financial penalty program. One critical barrier in assessing
readmission risk is the lack of an easily-measured 'vital sign' for COPD: accurate, timely
measurements of lung function. Unlike other medical problems that have validated,
easily-obtained measurements of organ function, COPD evaluation often defaults to patient
report and physician evaluation without critical physiologic data. This lack of objective
pulmonary function data during AECOPD in turn leads to critical errors in disease severity
assessment. However, the required, repeated measurements by spirometry that can demonstrate
responses to therapy can be time-consuming and expensive to perform in a laboratory, and both
equipment and staffing infrastructure for bedside testing is cumbersome and often not
prioritized. For these reasons, spirometry frequently is not done for patients with AECOPD.
To monitor patient responses to therapy and to assess risks based on objective measures, the
investigators propose to the study the use of a portable, patient-driven device ("SpiroPD")
that can be used in both in-patient and outpatient settings, and that reports (via the
internet) values collected in real time. While the device has been used in the lung
transplant community and for patients with cystic fibrosis, no studies have been done to
validate its use in COPD. This protocol involves in-hospital patient training with the device
followed by serial measurements at home in the first 30 days post hospital-discharge.
Demonstration in a pilot, single-center trial of the usefulness of real-time, repeated
hand-held spirometry to provide objective measurements of lung function in AECOPD will have a
substantial impact on both patient health outcomes and on health care utilization and will
set the stage for appropriate next-step studies and NIH grant applications. It is unknown
whether this specific technology will be acceptable in the target population, though previous
research suggests that older patients may be more willing to use home monitoring technology.
This multi-disciplinary research team includes providers from the Department of Medicine and
the UCM COPD Readmissions Program team.
