Trial Outcomes & Findings for Feasibility of At-Home Handheld Spirometry (NCT NCT03284203)

Last Updated: 2023-05-31

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

30 days from patient enrollment

Results posted on

2023-05-31

Participant Flow

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

No participants were excluded from the study except those who did not meet the eligibility criteria.

Participant milestones

Participant milestones
Measure	SpiroPD Participants in the intervention arm will be given a handheld spirometry device to take home and use daily for 30 consecutive days. 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.
Overall Study STARTED	8
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	SpiroPD Participants in the intervention arm will be given a handheld spirometry device to take home and use daily for 30 consecutive days. 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.
Overall Study Lost to Follow-up	3

Baseline Characteristics

Feasibility of At-Home Handheld Spirometry

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SpiroPD n=8 Participants Participants in the intervention arm will be given a handheld spirometry device to take home and use daily for 30 consecutive days. 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.
Age, Continuous	61.85 years STANDARD_DEVIATION 9.52 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black/African American	7 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · American Indian/Alaskan Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Native Hawaiian/Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic/Latino	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days from patient enrollment

Population: We have reported data from baseline KOKO spirometry measurements vs. in-hospital SpiroPD use. However, none of the 8 enrolled participants used the SpiroPD device at home and thus, no data from at-home spirometry exists for this analysis.

Outcome measures

Outcome measures
Measure	SpiroPD n=8 Participants Participants in the intervention arm will be given a handheld spirometry device to take home and use daily for 30 consecutive days. 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.
Comparison of KOKO Spirometry to SpiroPD Use FVC % Predicted KOKO	57.01 percentage of FVC Standard Deviation 22.83
Comparison of KOKO Spirometry to SpiroPD Use FVC % Predicted Baseline SpiroPD	64.33 percentage of FVC Standard Deviation 24.15

SECONDARY outcome

Timeframe: 30 days from patient enrollment

Population: None of the 8 enrolled participants adhered to using the SpiroPD at home. No at-home data was able to be collected during this study; thus, there are no results to report.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days from patient enrollment

Population: There were no inquiries received on the SpiroPD help line. Thus, there is no data to report regarding the feasibility of SpiroPD.

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.

Outcome measures

Outcome data not reported

Adverse Events

SpiroPD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mary Akel

University of Chicago

Phone: 773-834-4489

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place