Trial Outcomes & Findings for At Home Spirometry and Video Module Education for COPD Patients (NCT NCT03834350)

Results Overview

Number of participants who completed the virtual education module at least once before the 30 day follow-up visit.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

71 participants

Primary outcome timeframe

30 days

Results posted on

2022-07-22

Participant Flow

The study team enrolled hospitalized adults at an academic medical center with COPD between April 2019 and June 2021 who met the following selection criteria: age\>18yrs, owned a wifi-enabled device, had or will have a rescue and/or controller meter dose inhaler prescribed upon discharge, had a visual acuity of at least 20/50, and received assent for approach by the treating clinician.

There were 71 participants who were enrolled and completed informed written consent. 71 participants were also assigned to the arms of this study. However, prior to completion of the baseline visit 1 participant withdrew.70 total participants were included in our final analyses.

Participant milestones

Participant milestones
Measure	Breathes Program Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD. BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital. BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.
Overall Study STARTED	71
Overall Study COMPLETED	70
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Breathes Program Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD. BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital. BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

At Home Spirometry and Video Module Education for COPD Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Breathes Program n=70 Participants Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD. BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital. BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.
Age, Continuous	63 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	70 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	68 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	70 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Number of participants who completed the virtual education module at least once before the 30 day follow-up visit.

Outcome measures

Outcome measures
Measure	At-Home Breathes Program n=70 Participants Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD. BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital. 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. A small device will be attached to track real-time medication use. BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.
Virtual Education Module Adherence	17 Participants

PRIMARY outcome

Timeframe: 30 days

Number of participants who used the SpiroPD device to perform lung function test and keep track of medications post-discharge.

Outcome measures

Outcome measures
Measure	At-Home Breathes Program n=70 Participants Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD. BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital. 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. A small device will be attached to track real-time medication use. BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.
Rate of SpiroPD Device Usage for At-Home COPD Self-Management	3 Participants

PRIMARY outcome

Timeframe: Baseline; Baseline post-education; 30-day post-discharge

Population: Due to participant retention, only 24 participants attended their 30-day follow up visit and were able to have their inhaler technique assessed.

Percent of participants who misused their inhalers (≤10/12 steps correct) at baseline, post-baseline inhaler education, and at 30-day follow-up

Outcome measures

Outcome measures
Measure	At-Home Breathes Program n=70 Participants Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD. BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital. 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. A small device will be attached to track real-time medication use. BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.
Inhaler Technique Baseline Misuse	55 Participants
Inhaler Technique Baseline Post-education Misuse	17 Participants
Inhaler Technique 30d post-discharge Misuse	10 Participants

SECONDARY outcome

Timeframe: Baseline Pre-VTTG (right before the lesson); Baseline Post-VTTG (immediately after baseline lesson - within 30 minutes)

Population: Only 69 participants answered this question due to a technology error that occurred that affected only 1 participant.

Patient self-efficacy regarding proper inhaler technique on a 5 point Likert scale, 1 to 5 where 1 is Not Sure at All and 5 is Completely Sure. This outcome was measured at baseline just prior to VTTG inhaler education and again at baseline immediately after VTTG inhaler education. Scores of 3-5 were coded as "confident"; scores of 1-2 were coded as "not confident".

Outcome measures

Outcome measures
Measure	At-Home Breathes Program n=69 Participants Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD. BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital. 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. A small device will be attached to track real-time medication use. BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.
Change in Self-Efficacy for Inhalers: 5 Point Likert Scale Baseline Pre-VTTG Confident	47 Participants
Change in Self-Efficacy for Inhalers: 5 Point Likert Scale Baseline Pre-VTTG not confident	22 Participants
Change in Self-Efficacy for Inhalers: 5 Point Likert Scale Baseline Post-VTTG confident	49 Participants
Change in Self-Efficacy for Inhalers: 5 Point Likert Scale Baseline Post-VTTG not confident	20 Participants

SECONDARY outcome

Timeframe: Baseline; 30 days post-discharge

Population: Due to retention in the study, only 43 participants were able to be assessed at the 30d follow-up visit.

Self reported measure using two validated surveys, The Modified Borg Dyspnea Scale (rating of shortness of breath from 0-10 where 0 is not at all and 10 is maximal) and a modified COPD Severity Tool (the possible COPD severity score range is 0 to 26, with higher scores reflecting more severe disease). These measures were assessed at baseline prior to VTTG education and again 30 days post-discharge.

Outcome measures

Outcome measures
Measure	At-Home Breathes Program n=70 Participants Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD. BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital. 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. A small device will be attached to track real-time medication use. BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.
Change in Symptom Burden Baseline modified COPD Severity Score	12.03 score on a scale Standard Deviation 6.17
Change in Symptom Burden Baseline Borg Dyspnea	2.97 score on a scale Standard Deviation 2.79
Change in Symptom Burden 30d post-discharge Borg Dyspnea	2.28 score on a scale Standard Deviation 2.35
Change in Symptom Burden 30d post-discharge modified COPD Severity Score	12.72 score on a scale Standard Deviation 6.08

SECONDARY outcome

Timeframe: Baseline; 30 days post-discharge

Population: Due to retention, only 43 participants attended the 30d follow-up visit and completed the AQ-20

Using the validated survey, The Airway Questionnaire (AQ-20), a 20-item survey that assesses effect of current symptoms in everyday life for patients with COPD, to assess the change in quality of life from before the BREATHES program to after. The AQ-20 contains 20 items, with scores ranging from 0 to 20 (total score maximum is 20). High scores indicate poor quality of life. This measure was assessed at Baseline prior to VTTG education and again at 30 days post-discharge.

Outcome measures

Outcome measures
Measure	At-Home Breathes Program n=70 Participants Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD. BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital. 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. A small device will be attached to track real-time medication use. BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.
Change in Quality of Life: The Airway Questionnaire (AQ-20) Baseline AQ-20	10.06 score on a scale (0-20) Standard Deviation 4.45
Change in Quality of Life: The Airway Questionnaire (AQ-20) 30d post-discharge AQ-20	11.70 score on a scale (0-20) Standard Deviation 4.07

SECONDARY outcome

Timeframe: 30 day

Population: Only 69 participants had their charts reviewed because one participant withdrew from the study after the initial study visit and therefore no additional data was pulled.

Using University of Chicago Medical Center data and chart reviews, the investigators will examine the use of acute care services within the 30 day window of participation within the study.

Outcome measures

Outcome measures
Measure	At-Home Breathes Program n=69 Participants Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD. BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital. 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. A small device will be attached to track real-time medication use. BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may 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. A small device will be attached to track real-time medication use.
Use of Acute Care Services 30 day all admissions	19 Participants
Use of Acute Care Services 30 day COPD admissions	8 Participants
Use of Acute Care Services 30 day all ED visits	17 Participants
Use of Acute Care Services 30 day COPD ED visits	6 Participants
Use of Acute Care Services 30 day all ICU admissions	1 Participants
Use of Acute Care Services 30 day COPD ICU admissions	0 Participants

Adverse Events

Breathes Program

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

Dr. Valerie Press

University of Chicago

Phone: 773-702-5170

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place