Feasibility of At-Home Handheld Spirometry

NCT03284203 | Terminated Results FDA Device

• 1 other identifier: IRB17-0562
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

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.

  30 days from patient enrollment

Secondary Outcomes (2)

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

  30 days from patient enrollment

• Feasibility of Patients to Use the SpiroPD Device at Home Consistently

  30 days from patient enrollment

Study Arms (1)

SpiroPD

EXPERIMENTAL

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

SpiroPD DEVICE

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.

SpiroPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mary Akel
• Organization: University of Chicago

makel@medicine.bsd.uchicago.edu

773-834-4489

Study Officials

• Valerie Press

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 15, 2017
• Study Start: September 30, 2017
• Primary Completion: November 20, 2017
• Study Completion: March 1, 2018
• Last Updated: May 31, 2023
• Results First Posted: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)