CClinicalTrials.gg
TerminatedNCT03284203Updated May 31, 2023Results posted

Feasibility of At-Home Handheld Spirometry

An interventional study of SpiroPD in COPD, sponsored by University of Chicago. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-31.

Sponsored by University of Chicago · Not applicable, Interventional, and Health services research

Why this study was terminated
The aims represented in this study are also included in another, larger study of at-home COPD care. There was insufficient research team support to complete both protocols and the work would have been duplicative. Thus, we have terminated this study.
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • COPD
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18+ years
  • Physician-diagnosed COPD
  • Able to perform spirometry
  • Access to wireless internet at home
  • Visual acuity of at least 20/50 in one eye

Exclusion criteria

Exclusion Criteria:

  • Currently in ICU
  • Physician declines to provide consent
  • Patient unable to provide consent or declines to provide consent
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    SpiroPD

    Participants in the intervention arm will be given a handheld spirometry device to take home and use daily for 30 consecutive days.

    Device: SpiroPD

Interventions

  • DeviceSpiroPD

    At the time of their initial study visit, study participants will be given a SpiroPD device for use at home following instruction in the hospital or clinic. Patient adherence to daily testing over one-month will be monitored using real-time capture Wi-Fi-data from the SpiroPD data portal.

05

What researchers measure

Primary outcomes

  1. Comparison of KOKO Spirometry to SpiroPD Use

    Participants will use the handheld spirometry device every day for 30 days. After use, the device will store spirometry measurements for each patient each day and the data will be synced over wifi to each individual's associated online account. Daily measurements from the SpiroPD device will be collected over the course of 30 days. These measurements will then be compared against spirometry measurements collected using the bedside KoKo machine during baseline and 30-day follow-up visits.

    Time frame: 30 days from patient enrollment

Secondary outcomes

  1. Adherence to Using the SpiroPD Device at Home on a Daily Basis

    Daily use of the SpiroPD will be measured by way of captured spirometry measurements. If there is no recorded spirometry measurement in the SpiroPD device for certain days, those days will be considered when discussing non-adherence to daily use of the SpiroPD.

    Time frame: 30 days from patient enrollment

  2. Feasibility of Patients to Use the SpiroPD Device at Home Consistently

    Feasibility, or ease of use, will be measured by tracking the number of inquiries received on the designated SpiroPD help line. Each inquiry will be measured and tracked using an inquiry intake form. The type of inquiry or issue the patient is having and the possible solutions to the issue will be recorded. The patient's study ID and the date and time of their call will be recorded. These metrics along with adherence measurements will be factored in when discussing the feasibility of the SpiroPD device.

    Time frame: 30 days from patient enrollment

06

Results

Posted May 31, 2023

Participant flow

Participants enrolled from September to December 2017 at the University of Chicago Medical Center.

Participant flow — Overall Study
MilestoneSpiroPD
Started8
Completed5
Not completed3
Withdrew: Lost to follow-up3

Outcome measures

PrimaryComparison of KOKO Spirometry to SpiroPD Use

Participants will use the handheld spirometry device every day for 30 days. After use, the device will store spirometry measurements for each patient each day and the data will be synced over wifi to each individual's associated online account. Daily measurements from the SpiroPD device will be collected over the course of 30 days. These measurements will then be compared against spirometry measurements collected using the bedside KoKo machine during baseline and 30-day follow-up visits.

Time frame:
30 days from patient enrollment
Reported as:
Mean · percentage of FVC
Comparison of KOKO Spirometry to SpiroPD Use
percentage of FVCSpiroPD
FVC % Predicted KOKO57.01 ± 22.83
FVC % Predicted Baseline SpiroPD64.33 ± 24.15
SecondaryAdherence to Using the SpiroPD Device at Home on a Daily Basis

Daily use of the SpiroPD will be measured by way of captured spirometry measurements. If there is no recorded spirometry measurement in the SpiroPD device for certain days, those days will be considered when discussing non-adherence to daily use of the SpiroPD.

Time frame:
30 days from patient enrollment

No measurements were reported for this outcome.

SecondaryFeasibility of Patients to Use the SpiroPD Device at Home Consistently

Feasibility, or ease of use, will be measured by tracking the number of inquiries received on the designated SpiroPD help line. Each inquiry will be measured and tracked using an inquiry intake form. The type of inquiry or issue the patient is having and the possible solutions to the issue will be recorded. The patient's study ID and the date and time of their call will be recorded. These metrics along with adherence measurements will be factored in when discussing the feasibility of the SpiroPD device.

Time frame:
30 days from patient enrollment

No measurements were reported for this outcome.

Adverse events

Collected over Participants were assessed over 30 days post hospital discharge after enrollment into this study.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SpiroPD0/8 (0%)0/8 (0%)0/8 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)SpiroPD
Mean61.85 ± 9.52
Sex: Female, Male
Sex: Female, Male(Participants)SpiroPD
Female5
Male3
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)SpiroPD
Race/Ethnicity — White1
Race/Ethnicity — Black/African American7
Race/Ethnicity — Asian0
Race/Ethnicity — American Indian/Alaskan Native0
Race/Ethnicity — Native Hawaiian/Other Pacific Islander0
Race/Ethnicity — Hispanic/Latino0
Race/Ethnicity — Other0
Region of Enrollment
Region of Enrollment(participants)SpiroPD
United States8
07

Study locations

1 site
  • University of Chicago Medicine
    Chicago, Illinois 60637, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 8, 2018
  • Informed consent form · Apr 8, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03284203
Lead sponsor
University of Chicago
Responsible party
Sponsor
First posted
Sep 15, 2017
Start date
Sep 30, 2017
Primary completion
Nov 20, 2017
Completion
Mar 1, 2018
Results posted
May 31, 2023
Last update
May 31, 2023

Study contacts

Valerie Press
principal investigator · University of Chicago

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
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