COPDNCT03284203
Feasibility of At-Home Handheld Spirometry
A study testing SpiroPD in people with COPD, run by University of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- SpiroPD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2017to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently in ICU
- Physician declines to provide consent
- Patient unable to provide consent or declines to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medicine
Chicago, Illinois, 60637
About this study
Official title: Feasibility of Inpatient and At-Home Use of Handheld Spirometry (SpiroPD)
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.
Read more
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.
- Conditions
- COPD
- Being tested
- SpiroPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpiroPDDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SpiroPD | Experimental | Participants in the intervention arm will be given a handheld spirometry device to take home and use daily for 30 consecutive days. Receives: Device: SpiroPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days from patient enrollment
Secondary outcomes (2)
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.
Measured: 30 days from patient enrollment
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.
Measured: 30 days from patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start30 Sep 2017
- Primary completion20 Nov 2017
- Study completion1 Mar 2018
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valerie Press, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284203
- Sponsor's protocol ID
- IRB17-0562
- Status last verified
- May 2023
- First submitted
- 8 Sep 2017
- Last updated
- 31 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Inpatient and At-Home Use of Handheld Spirometry (SpiroPD)
- ClinicalTrials.gov ID
- NCT03284203
- Acronym / sponsor ID
- IRB17-0562
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 15 Sep 2017 (actual)
- Results
- Posted 31 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SpiroPD | Experimental | Device: SpiroPDParticipants in the intervention arm will be given a handheld spirometry device to take home and use daily for 30 consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Currently in ICU
- Physician declines to provide consent
- Patient unable to provide consent or declines to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpiroPDAt 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. | Device | SpiroPD |
Primary outcome
Comparison of KOKO Spirometry to SpiroPD Use
Time frame: 30 days from patient enrollment
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.
2 secondary outcomes
Adherence to Using the SpiroPD Device at Home on a Daily Basis
Time frame: 30 days from patient enrollment
Feasibility of Patients to Use the SpiroPD Device at Home Consistently
Time frame: 30 days from patient enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for COPD
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
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.
Valerie Press principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpiroPD in people with COPD, run by University of Chicago 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 31 May 2023. 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?
Yes. Results are posted in the registry (first posted 31 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comparison of KOKO Spirometry to SpiroPD Use (time frame: 30 days from patient enrollment). 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 31 May 2023.