Feasibility of SpiroPD

• ClinicalTrials.gov Identifier: NCT03284203
• Recruitment Status: Terminated
• First Posted: September 15, 2017
• Last Update Posted: January 25, 2021
• Sponsor: University of Chicago
• Information provided by (Responsible Party): University of Chicago

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
COPD	Device: SpiroPD	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Feasibility of Inpatient and At-Home Use of Handheld Spirometry
• Actual Study Start Date: September 30, 2017
• Actual Primary Completion Date: May 1, 2020
• Actual Study Completion Date: May 1, 2020

Arms and Interventions

Arm	Intervention/treatment
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; 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.

Outcome Measures

Primary Outcome Measures :

1. Spirometry measurements from use of SpiroPD instrument [ 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.

Secondary Outcome Measures :

1. Adherence to using the SpiroPD device at home on a daily basis [ Time Frame: 30 days from patient enrollment ]
   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.
2. Feasibility of Patients to use the SpiroPD device at home consistently [ Time Frame: 30 days from patient enrollment ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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:

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

Contacts and Locations

Locations

United States, Illinois

University of Chicago Medicine

Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Investigators

• Principal Investigator: Valerie Press; University of Chicago

More Information

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT03284203
• Other Study ID Numbers: IRB17-0562
• First Posted: September 15, 2017
• Last Update Posted: January 25, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes