Inhaler Trainer Efficacy Study

Asthma Clinical Trial

Official title:

Inhaler Trainer Efficacy Study: Interactive Training Tool Providing Technique Feedback for COPD/Asthma Medication Delivery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06461403
• Other study ID #: IRB21-1418
• Secondary ID: 5R44AG071430
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: October 1, 2025

Study information

• Verified date: June 2024
• Source: Koronis Biomedical Technologies
• Contact: May Nguyen
• Phone: 916-467-6688
• Email: mayqnguyen[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: October 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Exacerbation of COPD
• Asthma
• Copd

Intervention

Device:
• Inhaler Trainer System
The system consists of an instrumented training inhaler capable of accurately measuring the real-time inspiratory airflow achieved by the user when they perform their inhale maneuver. The inhaler trainer system consists of a detachable/disposable mouthpiece and a reusable electronics module. The electronics module measures flow/pressure achieved by the patient and wirelessly transmits this data to a PC. The PC software analyzes the real-time inhalation flow data to enable the monitoring of the following quantities: Flow Rate, Duration, and Maximum Pressure Slope. These quantities will be used in the computation of the assessment metric, providing the user with real-time feedback about their inhalation technique. In addition, the software includes features to support the human study and provides fully functional inhaler education features for the expert test evaluators.

Other:
• Initial Inhaler Use Assessment
Patients will undergo an initial assessment of their respiratory inhaler technique for their respiratory inhaler devices using device-specific checklists
• Inhaler Use Instruction
Participants will then be given step-by-step verbal instructions and a copy of written instructions by the trained educator describing appropriate inhaler technique for their respiratory inhalers.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Koronis Biomedical Technologies	National Institute on Aging (NIA), University of Chicago

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Spirometer pulmonary function measure: FVC	Forced Vital Capacity (FVC). Scores will be compared to baseline at 6 weeks post inhaler technique training.	6 weeks
Secondary	Spirometer pulmonary function measure: PEF	Peak Expiratory Flow (PEF). Scores will be compared to baseline at 6 weeks post inhaler technique training.	6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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