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At Home Spirometry and Video Module Education for COPD Patients

BREATHES: Bringing Respiratory Education for Improved Adherence and Technique Home Through E-interventions for Self-management

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03834350
Acronym
BREATHES
Enrollment
71
Registered
2019-02-07
Start date
2019-04-11
Completion date
2021-06-23
Last updated
2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Brief summary

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.

Detailed description

Chronic obstructive pulmonary disease (COPD) results in nearly 750,000 hospitalizations annually and is the third leading cause of 30-day hospital readmissions in the United States.Improving the quality of care for hospitalized COPD patients has recently become a national priority through the Centers for Medicare and Medicaid Services' Hospital Readmissions Reduction Program. A key element of improving care quality is translating existing evidence into improved practice. Extensive evidence exists to support the efficacy of inhaled medications to control and reduce COPD symptoms and to improve patient outcomes. However, the real-world effectiveness of these medications is often limited due both to poor inhaler technique and to insufficient adherence to treatment plans. Most interventions for hospitalized patients with COPD focus on medication reconciliation, treatment optimization, and inhaler technique education prior to being discharged home. However, after discharge home, patients quickly lose inhaler technique skills, have difficulty adhering to complex regimens, and lack tools to aid adherence, such as lung function response to their treatment regimen. Interventions to reinforce skills and support adherence are needed across care transitions to reduce the risk of deleterious health outcomes. Simple and feasible at-home interventions to provide skills training and adherence support are needed. This novel idea is to pair at-home inhaler skill training with at-home spirometry measurements to comprehensively support both medication skill and adherence. The investigator proposes testing a novel at-home self-management support program called BREATHES (Bringing Respiratory Education for improved Adherence and Technique Home through E-interventions for Self-management) Program. BREATHES will include two main components: first, self-directed inhaler skill training sessions through the virtual Teach-To-Goal (V-TTG) intervention the investigator developed and tested during a K23 grant and, second, a handheld lung function device to provide physiologic feedback and capture medication adherence called SpiroPD. TTG is a patient-centered strategy that uses cycles of assessment and demonstration tailored to patients' self-management needs; the investigator's research shows in-person TTG is effective for teaching inhaler technique and reduces acute care utilization. Virtual-TTG delivers the key features of TTG using virtual patient-directed lessons through novel adaptive technology that provides tailored self-assessment and training. The investigator's studies demonstrate participants' willingness to use V-TTG at-home for post-discharge booster education and show that V-TTG is effective and may be non-inferior to in-person TTG in significantly reducing inhaler misuse among hospitalized patients. However, it remains unknown whether at-home V-TTG sessions will maintain self-management skills over the longer term and how direct physiologic lung monitoring support can impact medication adherence. The proposed studies will determine whether combining at-home skill training with objective measurements of lung function and adherence monitoring through the BREATHES Program improves self-management skills and medication adherence in the first 30 days after hospitalization for COPD.

Interventions

OTHERBREATHES 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.

DEVICEBREATHES 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.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Chicago
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age 18 years and older 2. Physician-diagnosed COPD (prior to or during hospitalization) 3. Owns a wifi-enabled device (desktop, laptop, tablet, smart phone, etc.) 4. Discharged with a rescue and/or controller MDI (metered dose inhaler).

Exclusion criteria

1. Currently in an intensive care unit 2. Physician declines to provide consent 3. Patient unable to provide consent (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent

Design outcomes

Primary

MeasureTime frameDescription
Virtual Education Module Adherence30 daysNumber of participants who completed the virtual education module at least once before the 30 day follow-up visit.
Rate of SpiroPD Device Usage for At-Home COPD Self-Management30 daysNumber of participants who used the SpiroPD device to perform lung function test and keep track of medications post-discharge.
Inhaler TechniqueBaseline; Baseline post-education; 30-day post-dischargePercent of participants who misused their inhalers (≤10/12 steps correct) at baseline, post-baseline inhaler education, and at 30-day follow-up

Secondary

MeasureTime frameDescription
Change in Self-Efficacy for Inhalers: 5 Point Likert ScaleBaseline 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.
Use of Acute Care Services30 dayUsing 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.
Change in Symptom BurdenBaseline; 30 days post-dischargeSelf 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.
Change in Quality of Life: The Airway Questionnaire (AQ-20)Baseline; 30 days post-dischargeUsing 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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
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.
70
Total70

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyWithdrawal by Subject1

Baseline characteristics

CharacteristicBreathes Program
Age, Continuous63 years
STANDARD_DEVIATION 8.4
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
70 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
68 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
1 Participants
Region of Enrollment
United States
70 participants
Sex: Female, Male
Female
40 Participants
Sex: Female, Male
Male
30 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 70
other
Total, other adverse events
0 / 70
serious
Total, serious adverse events
0 / 70

Outcome results

Primary

Inhaler Technique

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

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
At-Home Breathes ProgramInhaler TechniqueBaseline Misuse55 Participants
At-Home Breathes ProgramInhaler TechniqueBaseline Post-education Misuse17 Participants
At-Home Breathes ProgramInhaler Technique30d post-discharge Misuse10 Participants
Primary

Rate of SpiroPD Device Usage for At-Home COPD Self-Management

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

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
At-Home Breathes ProgramRate of SpiroPD Device Usage for At-Home COPD Self-Management3 Participants
Primary

Virtual Education Module Adherence

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

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
At-Home Breathes ProgramVirtual Education Module Adherence17 Participants
Secondary

Change in Quality of Life: The Airway Questionnaire (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.

Time frame: Baseline; 30 days post-discharge

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

ArmMeasureGroupValue (MEAN)Dispersion
At-Home Breathes ProgramChange in Quality of Life: The Airway Questionnaire (AQ-20)Baseline AQ-2010.06 score on a scale (0-20)Standard Deviation 4.45
At-Home Breathes ProgramChange in Quality of Life: The Airway Questionnaire (AQ-20)30d post-discharge AQ-2011.70 score on a scale (0-20)Standard Deviation 4.07
Secondary

Change in Self-Efficacy for Inhalers: 5 Point Likert Scale

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.

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
At-Home Breathes ProgramChange in Self-Efficacy for Inhalers: 5 Point Likert ScaleBaseline Pre-VTTG Confident47 Participants
At-Home Breathes ProgramChange in Self-Efficacy for Inhalers: 5 Point Likert ScaleBaseline Pre-VTTG not confident22 Participants
At-Home Breathes ProgramChange in Self-Efficacy for Inhalers: 5 Point Likert ScaleBaseline Post-VTTG confident49 Participants
At-Home Breathes ProgramChange in Self-Efficacy for Inhalers: 5 Point Likert ScaleBaseline Post-VTTG not confident20 Participants
Secondary

Change in Symptom Burden

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
At-Home Breathes ProgramChange in Symptom BurdenBaseline Borg Dyspnea2.97 score on a scaleStandard Deviation 2.79
At-Home Breathes ProgramChange in Symptom Burden30d post-discharge Borg Dyspnea2.28 score on a scaleStandard Deviation 2.35
At-Home Breathes ProgramChange in Symptom BurdenBaseline modified COPD Severity Score12.03 score on a scaleStandard Deviation 6.17
At-Home Breathes ProgramChange in Symptom Burden30d post-discharge modified COPD Severity Score12.72 score on a scaleStandard Deviation 6.08
Secondary

Use of Acute Care Services

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.

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
At-Home Breathes ProgramUse of Acute Care Services30 day all ED visits17 Participants
At-Home Breathes ProgramUse of Acute Care Services30 day all admissions19 Participants
At-Home Breathes ProgramUse of Acute Care Services30 day COPD admissions8 Participants
At-Home Breathes ProgramUse of Acute Care Services30 day COPD ED visits6 Participants
At-Home Breathes ProgramUse of Acute Care Services30 day all ICU admissions1 Participants
At-Home Breathes ProgramUse of Acute Care Services30 day COPD ICU admissions0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026