COPDBREATHESNCT03834350
At Home Spirometry and Video Module Education for COPD Patients
A study testing BREATHES Program and BREATHES SpiroPD or Propeller Health in people with COPD, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- BREATHES Program and BREATHES SpiroPD or Propeller Health
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2019to 23 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Physician-diagnosed COPD (prior to or during hospitalization)
- Owns a wifi-enabled device (desktop, laptop, tablet, smart phone, etc.)
- Discharged with a rescue and/or controller MDI (metered dose inhaler).
Who cannot join
- Currently in an intensive care unit
- Physician declines to provide consent
- Patient unable to provide consent (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medicine
Chicago, Illinois, 60637
About this study
Official title: BREATHES: Bringing Respiratory Education for Improved Adherence and Technique Home Through E-interventions for Self-management
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.
Read more
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.
Read the 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.
- Conditions
- COPD
- Being tested
- BREATHES Program, BREATHES SpiroPD or Propeller Health
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BREATHES ProgramOther
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 HealthDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| At-Home Breathes Program | Other | 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. Receives: Other: BREATHES Program; Device: BREATHES SpiroPD or Propeller Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virtual Education Module Adherence
Number of participants who completed the virtual education module at least once before the 30 day follow-up visit.
Measured: 30 days
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.
Measured: 30 days
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
Measured: Baseline; Baseline post-education; 30-day post-discharge
Secondary outcomes (4)
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".
Measured: Baseline Pre-VTTG (right before the lesson); Baseline Post-VTTG (immediately after baseline lesson - within 30 minutes)
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.
Measured: Baseline; 30 days post-discharge
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.
Measured: Baseline; 30 days post-discharge
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.
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start11 Apr 2019
- Primary completion23 Jun 2021
- Study completion23 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Valerie G Press, MD, MPH, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834350
- Sponsor's protocol ID
- IRB18-1210
- Other IDs
- R03HL144883
- Acronym
- BREATHES
- Status last verified
- Jul 2022
- First submitted
- 1 Feb 2019
- Last updated
- 22 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BREATHES: Bringing Respiratory Education for Improved Adherence and Technique Home Through E-interventions for Self-management
- ClinicalTrials.gov ID
- NCT03834350
- Acronym / sponsor ID
- BREATHES / IRB18-1210
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 7 Feb 2019 (actual)
- Results
- Posted 22 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| At-Home Breathes Program | Other | Other: BREATHES Program, Device: BREATHES SpiroPD or Propeller HealthParticipants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years and older
- Physician-diagnosed COPD (prior to or during hospitalization)
- Owns a wifi-enabled device (desktop, laptop, tablet, smart phone, etc.)
- Discharged with a rescue and/or controller MDI (metered dose inhaler).
Key exclusion criteria (3 listed)
- Currently in an intensive care unit
- Physician declines to provide consent
- Patient unable to provide consent (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BREATHES ProgramParticipants 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. | Other | At-Home Breathes Program |
| BREATHES SpiroPD or Propeller HealthAt 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. | Device | At-Home Breathes Program |
Primary outcome
Virtual Education Module Adherence
Time frame: 30 days
Number 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-Management
Time frame: 30 days
Number of participants who used the SpiroPD device to perform lung function test and keep track of medications post-discharge.
Inhaler Technique
Time frame: 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
4 secondary outcomes
Change in Self-Efficacy for Inhalers: 5 Point Likert Scale
Time frame: Baseline Pre-VTTG (right before the lesson); Baseline Post-VTTG (immediately after baseline lesson - within 30 minutes)
Change in Symptom Burden
Time frame: Baseline; 30 days post-discharge
Change in Quality of Life: The Airway Questionnaire (AQ-20)
Time frame: Baseline; 30 days post-discharge
Use of Acute Care Services
Time frame: 30 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie G Press, MD, MPH principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BREATHES Program and BREATHES SpiroPD or Propeller Health in people with COPD, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virtual Education Module Adherence (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022; AzTrials last refreshed its copy on 2 Nov 2026.