N/A
N=71
At Home Spirometry and Video Module Education for COPD Patients
COPD
Bottom Line
View on ClinicalTrials.gov: NCT03834350 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Virtual Education Module Adherence — 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BREATHES Program (Other); BREATHES SpiroPD or Propeller Health (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Virtual Education Module Adherence |
17 | — |
| PRIMARY Rate of SpiroPD Device Usage for At-Home COPD Self-Management |
3 | — |
| PRIMARY Inhaler Technique |
55; 17; 10 | — |
| SECONDARY Change in Self-Efficacy for Inhalers: 5 Point Likert Scale |
47; 22; 49; 20 | — |
| SECONDARY Change in Symptom Burden |
2.97; 2.28; 12.03; 12.72 | — |
| SECONDARY Change in Quality of Life: The Airway Questionnaire (AQ-20) |
10.06; 11.70 | — |
| SECONDARY Use of Acute Care Services |
19; 8; 17; 6; 1; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03834350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.