NCT03834350: BREATHES

At Home Spirometry and Video Module Education for COPD Patients

Completed NA Results posted Last updated 22 July 2022

What this trial tests

NA trial testing BREATHES Program in COPD in 71 participants. Completed in 23 June 2021.

Timeline

11 April 2019

Primary endpoint
23 June 2021

23 June 2021

Quick facts

Lead sponsor	University of Chicago
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	71
Start date	11 April 2019
Primary completion	23 June 2021
Estimated completion	23 June 2021
Sites	1 location across United States

Drugs / interventions tested

• BREATHES Program
• BREATHES SpiroPD or Propeller Health

Conditions studied

• COPD — all drugs for COPD →

Sponsor

University of Chicago

Who can join

18 and older, any sex, with COPD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Virtual Education Module Adherence Primary · 30 days

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

Group	Value	95% CI
At-Home Breathes Program	17

Rate of SpiroPD Device Usage for At-Home COPD Self-Management Primary · 30 days

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

Group	Value	95% CI
Breathes Program	3

Inhaler Technique Primary · Baseline; Baseline post-education; 30-day post-discharge

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

Baseline Misuse

Group	Value	95% CI
Breathes Program	55

Baseline Post-education Misuse

Group	Value	95% CI
Breathes Program	17

30d post-discharge Misuse

Group	Value	95% CI
Breathes Program	10

Change in Self-Efficacy for Inhalers: 5 Point Likert Scale Secondary · Baseline Pre-VTTG (right before the lesson); Baseline Post-VTTG (immediately after baseline lesson - within 30 minutes)

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".

Baseline Pre-VTTG Confident

Group	Value	95% CI
Breathes Program	47

Baseline Pre-VTTG not confident

Group	Value	95% CI
Breathes Program	22

Baseline Post-VTTG confident

Group	Value	95% CI
Breathes Program	49

Baseline Post-VTTG not confident

Group	Value	95% CI
Breathes Program	20

Change in Symptom Burden Secondary · Baseline; 30 days post-discharge

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.

Baseline Borg Dyspnea

Group	Value	95% CI
Breathes Program	2.97	± 2.79

30d post-discharge Borg Dyspnea

Group	Value	95% CI
Breathes Program	2.28	± 2.35

Baseline modified COPD Severity Score

Group	Value	95% CI
Breathes Program	12.03	± 6.17

30d post-discharge modified COPD Severity Score

Group	Value	95% CI
Breathes Program	12.72	± 6.08

Change in Quality of Life: The Airway Questionnaire (AQ-20) Secondary · Baseline; 30 days post-discharge

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.

Baseline AQ-20

Group	Value	95% CI
Breathes Program	10.06	± 4.45

30d post-discharge AQ-20

Group	Value	95% CI
Breathes Program	11.70	± 4.07

Use of Acute Care Services Secondary · 30 day

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.

30 day all admissions

Group	Value	95% CI
Breathes Program	19

30 day COPD admissions

Group	Value	95% CI
Breathes Program	8

30 day all ED visits

Group	Value	95% CI
Breathes Program	17

30 day COPD ED visits

Group	Value	95% CI
Breathes Program	6

30 day all ICU admissions

Group	Value	95% CI
Breathes Program	1

30 day COPD ICU admissions

Group	Value	95% CI
Breathes Program	0

Sponsor's own description

The central hypothesis is that patients hospitalized for COPD who subsequently complete the at-home BREATHES Program with V-TTG skill training and SpiroPD adherence support will retain increased medication knowledge, skill, self-efficacy, and adherence that otherwise decays substantially by 30 days post-discharge. To test this hypothesis, this study proposes the following specific aims:

Aim 1: Determine the feasibility of, adherence to, and efficacy of at-home V-TTG for ongoing inhaler skill training.

Hypothesis: Participants who complete both in-hospital and at-home V-TTG will have a significantly increased likelihood of demonstrating effective respiratory inhaler technique within 30 days after hospital discharge compared to in-hospital technique

Aim 2. Determine the feasibility of, adherence to, and efficacy of at-home SpiroPD for COPD medication adherence support.

Hypothesis: Participants' use of SpiroPD (PMD Healthcare) will significantly improve their COPD medication adherence.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.