Inhaler Trainer Efficacy Study
NCT Number: NCT06461403
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Asthma|Copd|Acute Exacerbation of COPD
Interventions: DEVICE: Inhaler Trainer System|OTHER: Initial Inhaler Use Assessment|OTHER: Inhaler Use Instruction
Sponsor: Koronis Biomedical Technologies
Collaborators: University of Chicago|National Institute on Aging (NIA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2025-10-01

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.

Primary Outcome Measures: Inhaler technique assessment, Participants' overall inhaler technique will be scored via observation by a trained research educator. This assessment will follow a validated checklist and scoring system based the inhaler the patient is using. For example, if the patient is using a Spiriva handihaler, each of the following steps will be marked as either complete or incomplete: removes cap of inhaler and spacer, shakes inhaler up and down, attaches inhaler to spacer, breathes out fully, breathes out away from spacer/MDI, closes lips around spacer mouthpiece, presses down on canister one time, breathes in slowly, holds breath for at least five seconds, removes spacer from mouth before breathing normally, breathes normally for at least 30-60 seconds, repeats steps 2-11 for second puff. There will be a designated spot for any qualitative findings identified by the educator. Scores will be compared to baseline and post-training results at 6 weeks post-inhaler technique training., 6 weeks
Secondary Outcome Measures: Estimated inhaled dosage, Estimated inhaled dosage is estimated by the prototype training device and is used to inform the training session. Dosage will be compared to the baseline and training session. Dosage will be compared to the baseline and training session results at 6 weeks post inhaler technique training., 6 weeks|Usability, To assess the overall usability and acceptability of the system, a short Likert-type usability survey will be developed based on the system usability scale and tailored to their inhaler type. For example, participants may be asked on a scale from 1-5, to what degree they agree to statements similar to "I thought the training system was easy to use", with 1 being strongly disagree, and 5 being strongly agree. Participants will complete the assessment, which will be administered by a trained interviewer., 6 weeks|Spirometer pulmonary function measures, Forced Expiratory Volume in One Minute (FEV1). Scores will be compared to baseline at 6 weeks post inhaler technique training., 6 weeks|Spirometer pulmonary function measure: FVC, Forced Vital Capacity (FVC). Scores will be compared to baseline at 6 weeks post inhaler technique training., 6 weeks|Spirometer pulmonary function measure: PEF, Peak Expiratory Flow (PEF). Scores will be compared to baseline at 6 weeks post inhaler technique training., 6 weeks|Inhalation Parameters - flow slope, Flow slope will be measured by the prototype trainer device and compared to the baseline and training session at 6 weeks post inhaler technique training., 6 weeks|Inhalation Parameters - peak flow, Peak flow will be measured by the prototype trainer device and compared to the baseline and training session at 6 weeks post inhaler technique training., 6 weeks|Inhalation Parameters - total volume, Total volume will be measured by the prototype trainer device and compared to the baseline and training session results at 6 weeks post inhaler technique training., 6 weeks|Symptom Control: mMRC, Symptoms will be assessed with the mMRC(Modified Medical Research Counsel dyspnea scale assessment), a validated tool that stratifies severity of dyspnea in respiratory diseases, particularly COPD. It is often used to establish baseline functional impairment due to dyspnea attributable to respiratory disease. The minimum value from this tool is 0, which indicates that the patient "only gets breathless with strenuous exercise". The maximum value of the tool is 4, which indicates that the patient "is too breathless to leave the house or is breathless when dressing". Results will be compared to the baseline and training session results at 6 weeks post inhaler technique training., 6 weeks|Symptom Control: Modified Borg Dyspnea Scale, Symptoms will be assessed with the Modified Borg Dyspnea Scale. The minimum value of this tool is 0, which indicates that the patient experiences no shortness of breath. The maximum value of this tool is 10, which indicates that the patient is experiencing very severe shortness of breath. Results will be compared to the baseline and training session results at 6 weeks post inhaler technique training., 6 weeks|Symptom control: Asthma, Asthma symptoms will be measured by the following assessments: ASSI (Asthma Symptom Severity Index). Patients will give a number in response to the question: "How is your asthma/COPD right now?" from 0 - 10, with 0 indicating no symptoms, and 10 indicating maximal symptoms. Results will be compared to the baseline and training session results at 6 weeks post inhaler technique training., 6 weeks|Disease control: COPD, COPD disease control will be measured with the CAT (COPD Assessment Test), which is a questionnaire for people with COPD that is designed to measure the impact of COPD on a person's life. The questionnaire is composed of 8 statements/questions with which the patient responds on a 0-5 scale. Total scores for the questionnaire can range from 0 - 40, with 0 indicating well controlled COPD and 40 indicating extremely poorly controlled COPD. Results will be compared to the baseline and training session results at 6 weeks post inhaler technique training., 6 weeks|Disease control: Asthma, Asthma control will be measured with the asthma control questionnaire. This questionnaire measures the adequacy of asthma control and change in asthma control that occurs either spontaneously or as a result of treatment. It is a 20 item questionnaire surveying effects of breathing problems on patients' everyday life. There are two sections to the questionnaire. The first 13 questions have answers ranging from 1-3, (1 = YES, 2 = NO, and 3 = N/A). The last 7 questions have answers ranging from 1-4 (1 = YES, 2 = NO, 3 = UNABLE, 4 = N/A). Results will be compared to the baseline and training session results at 6 weeks post inhaler technique training., 6 weeks