Clinical trial NCT06461403: Inhaler Trainer Efficacy Study
Official title: Inhaler Trainer Efficacy Study: Interactive Training Tool Providing Technique Feedback for COPD/Asthma Medication Delivery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Asthma
Copd
Acute Exacerbation of COPD
Lead sponsor: Koronis Biomedical Technologies
Sponsor class: INDUSTRY
Collaborators: name: University of Chicago
name: National Institute on Aging (NIA)
First posted: 2024-06-17
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization
Primary purpose: OTHER

Brief summary: This will be a randomized, controlled, clinical trial. The investigators aim to determine the feasibility of and efficacy of the Inhaler Trainer Device for ongoing inhaler skill training.

The research team will enroll 140 patients from the inpatient or outpatient setting from the University of Chicago Medicine over the course of up to 12 months. Participants will complete assessments, a lung function test via spirometry, and inhaler education via either the Inhaler Trainer Device learning program or Brief Intervention.

All participants will return at 6 weeks (window of +/- one week) post-initial inhaler education for an in-person evaluation of their inhaler skills, lung function, and acute care utilization. Finally, a post-study semi-structured interview will be conducted to gather feedback on the device after the 6-week visit has been completed.

Detailed description: The research team will enroll 140 patients from the inpatient or outpatient setting from the University of Chicago Medicine inpatient services, COPD/APN clinic, general medicine clinic, and/or Pulmonary clinic until all participants have been enrolled (approximately over the course of 12 months).

Patients will be randomized into one of two treatment conditions: one including use of the inhaler training device and one with our standard brief intervention.

After obtaining informed consent, participants will complete assessments, including a lung function test via spirometry, and inhaler education via either the Inhaler Trainer Device learning program or standard education techniques. Participants randomized to the inhaler training device arm will be trained on how to use their inhaler and the inhaler trainer device. The Inhaler Trainer Device will monitor the patient's inspiratory waveform to confirm technique compliance based on objective metrics and provide feedback on how to better perform technique.

Participants will continue to use their inhaled medications with the inhaler trainer device for 6 weeks post-baseline. They will return at 6 weeks post-initial instruction for an in-person evaluation of their inhaler skills, lung function, and acute care utilization. Finally, a post-study semi-structured interview will be conducted to gather feedback on the device after the 6-week visit has been completed. This interview will occur either during the 6-week follow-up visit or at a later time via phone call or zoom call. In the interview, a standard elicitation framework guided by the Integrative Model (IM) of Behavioral Prediction and Change will be used to generate feedback on training experience. The research team will also prompt participants to give feedback on the design, content, and functionality of the inhaler and training system. Additional prompts and questions will be used to ensure that information is provided that speaks to participants' perceptions of the positive and negative consequences related to using the trainer.

The statistical team at the University of Chicago will conduct analyses including descriptive summaries using means, medians, proportions, scatterplots, and histograms to describe the data. McNemar's chi-squared tests will be used to compare 30-day follow-up and inhaler misuse (≤10/12 steps correct) post-education vs. baseline. To model over time, we will use generalized linear mixed method (GLMM) or generalized estimating equations (GEE). A two-tailed p-value less than 0.05 will define statistical significance. The sample size was powered on the primary outcome in Aim 1 for difference in correct MDI use (\>75% steps correct) between baseline and at 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Age 18-85
* Physician diagnosis of COPD or asthma
* Has been prescribed or is being prescribed one of the inhalers listed below (DPI inhaler product, Active pharmaceutical ingredient):

  1. Serevent®Diskus®(GSK), Salmeterol
  2. Incruse Ellipta (GSK), Umeclidinium
  3. Spiriva Handihaler (BIP),Tiotropium
  4. Tudorza Pressair (AstraZeneca), Aclidinium
* Inexperienced with inhaler trainer device (defined by never having had inhaler training using an auxiliary tool besides an actual inhaler and spacer)

Exclusion Criteria:

* Physician declines to provide assent
* Patient unable to provide consent (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent
* Does not meet inclusion criteria

Primary outcomes:
measure: Inhaler technique assessment
timeFrame: 6 weeks
Secondary outcomes:
measure: Estimated inhaled dosage
timeFrame: 6 weeks
measure: Usability
timeFrame: 6 weeks
measure: Spirometer pulmonary function measures
timeFrame: 6 weeks
measure: Spirometer pulmonary function measure: FVC
timeFrame: 6 weeks
measure: Spirometer pulmonary function measure: PEF
timeFrame: 6 weeks
measure: Inhalation Parameters - flow slope
timeFrame: 6 weeks
measure: Inhalation Parameters - peak flow
timeFrame: 6 weeks
measure: Inhalation Parameters - total volume
timeFrame: 6 weeks
measure: Symptom Control: mMRC
timeFrame: 6 weeks
measure: Symptom Control: Modified Borg Dyspnea Scale
timeFrame: 6 weeks
measure: Symptom control: Asthma
timeFrame: 6 weeks
measure: Disease control: COPD
timeFrame: 6 weeks
measure: Disease control: Asthma
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
References: