Asthma Clinical Trial
Official title:
Pre/Post Pilot Test of VME for the Video vs. TTG Respiratory Inhaler Technique Assessment and InstructioN Study
NCT number | NCT02278237 |
Other study ID # | IRB12-1844 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2014 |
Est. completion date | October 2015 |
Verified date | February 2019 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Asthma and Chronic obstructive pulmonary disease (COPD) results in over a million
hospitalizations in the United States annually and COPD is the third leading cause of 30-day
re-hospitalizations. Clinical trials have established the efficacy of treatments primarily
dispensed via respiratory inhaler devices that reduce morbidity and health care utilization
if they are used correctly. The effectiveness of these medications in real-world settings is
limited by the fact that patients often do not use inhalers correctly. Current guidelines
recommend assessing and teaching inhaler technique at all health care encounters, including
hospitalization. Over 75% of hospitalized patients in an urban, predominantly underserved
population misused their respiratory inhalers, highlighting a missed opportunity to educate
these patients with high potential to benefit. Hospitalization, therefore, provides a
potential 'teachable moment' to correct this misuse. My preliminary data indicate that one
strategy, in-person teach-to-goal (TTG), is effective in teaching hospitalized patients
proper inhaler technique and is more effective than simple verbal instruction. While TTG is a
promising, several limitations prevent widespread adoption. TTG is time-consuming and costly.
Also, reinforcement may be needed, which may be impractical with in-person TTG. One potential
method to surmount TTG's limitations is use of interactive video module education (VME) that
has the potential to be less costly, maintain fidelity, and be more easily extended into the
post-discharge setting than in-person TTG. Before widespread implementation of VME, it is
critical to rigorously develop and test VME for inhaler education in the hospital setting.
Ultimately, it will also be important to understand patients' ability and willingness to use
post-discharge VME for educational reinforcement to allow for this strategy to transition
patients across care settings from hospital to home.
We hypothesize that interactive VME will lead to non-inferior rates of ability to demonstrate
correct inhaler use compared to rates with TTG among hospitalized patients with Asthma or
COPD.
For this study we are testing the preliminary efficacy of VME to teach respiratory inhaler
technique prior to implementing a larger RCT to test the comparative effectiveness of VME
versus TTG.
Status | Completed |
Enrollment | 90 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age 18 years and older 2. Admission to the inpatient medical service and surgical service 3. Physician-diagnosed COPD or asthma. We will enroll patients even if the primary reason for admission is not COPD or asthma (e.g., patients admitted for heart failure, but with a physician diagnosis of COPD are eligible). 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Chicago |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Inhaler Misuse Pre- and Post-VME | Assess patient's inhaler technique using Inhaler checklists by the trained assessor. The primary outcome will be comparing post-intervention to pre-intervention scores; secondary outcome will be 30 days post-discharge visit We will define inhaler technique in two ways: Correct Use (i.e., >75% of steps correct) Mastery (i.e., perfect technique, 100% steps correct) |
Up to 30 days | |
Secondary | Symptom Burden | Assess patient's respiratory symptoms/morbidity, which includes the Borg symptom score, Asthma Symptom Severity Index (ASSI), Chronic Bronchitis Symptom Questionnaire, COPD Severity Score (CSS), Airway Questionnaire (AQ-20), COPD Helplessness Index (CHI) and demographic and other clinical information. | up to 30 days | |
Secondary | Quality of Life (QOL) | Use validated disease specific QOL tools (i.e., asthma or COPD QOL tools) | up to 30 days | |
Secondary | Self-efficacy of Inhaler Technique | Assess patient's confidence in using their inhalers. We will ask patients to report if they: strongly disagree/disagree/neutral/agree/strongly agree with the statement: "I am confident that I know how to use this respiratory inhaler correctly". |
up to 30 days |
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