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Video vs. TTG Respiratory Inhaler Technique Assessment and InstructioN (V-TRaIN)

Video vs. TTG Respiratory Inhaler Technique Assessment and InstructioN (V-TRaIN)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02611531
Enrollment
142
Registered
2015-11-20
Start date
2015-11-30
Completion date
2017-09-30
Last updated
2018-05-24

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

Conditions

Asthma, Chronic Obstructive Pulmonary Disease

Brief summary

The purpose of this study is to evaluate the effectiveness of two different ways to teach subjects while hospitalized how to use respiratory inhalers and to follow-up after discharge home from the hospital to determine durability of the education.

Detailed description

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. Unfortunately, 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. My work has found that over 75% of hospitalized patients in an urban, predominantly underserved population misuse 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 method to improve care for patients who use inhalers, several limitations prevent widespread adoption. First, TTG relies on in-person assessment and education, as well as training and monitoring instructors to ensure fidelity, making it time-consuming and costly. Also, because a single educational session does not ensure long-term retention, post-discharge 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), a method that has been used for health education in other clinical contexts. Through iterative self-assessments and video-demonstrations on a tablet computer, VME has the potential to be less costly, maintain fidelity, and be more easily extended into the post-discharge setting than in-person TTG. However, certain questions remain about VME. It is unclear whether VME will yield similar results when compared to TTG, or whether patients will have the ability to, and be willing to use, VME in the post-discharge setting. Therefore, 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.

Interventions

BEHAVIORALVideo Module Education (VME)

Participants will complete inhaler education on a tablet device

BEHAVIORALTeach-To-Goal (TTG)

Participants will complete intensive in-person inhaler education

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
The proportion of participants with metered dose inhaler (MDI) misuse post VME vs. TTG education. This will provide data on the short-term effectiveness of the interventions.Up to 30 daysAssess patient's inhaler technique using Inhaler checklists by the trained assessor.

Secondary

MeasureTime frameDescription
Symptom burdenUp to 30 daysSymptom burden will be assessed using interviewer-administered surveys
Quality of Life (QOL)up to 30 daysUse validated disease specific QOL tools (i.e., asthma or COPD QOL tools)
self-efficacy of inhaler techniqueup to 30 daysAssess patient's confidence in using their inhalers using a Likert scale response to the question I am confident that I know how to use this respiratory inhaler correctly.
Utilization of health care services (outpatient visits, ED and hospital admissions, deaths)Up to 30 days
Lung functionUp to 30 daysAssess patient's lung function via spirometry

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026