Ignite Creation Date:
2024-07-17 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461403
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-04-12
Brief Title:
Inhaler Trainer Efficacy Study
Sponsor:
Koronis Biomedical Technologies
Organization:
Koronis Biomedical Technologies
Study Overview
Official Title:
Inhaler Trainer Efficacy Study Interactive Training Tool Providing Technique Feedback for COPDAsthma Medication Delivery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 COPDAPN clinic general medicine clinic andor 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 patients 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 McNemars chi-squared tests will be used to compare 30-day follow-up and inhaler misuse 1012 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 005 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
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 patients 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 McNemars chi-squared tests will be used to compare 30-day follow-up and inhaler misuse 1012 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 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R44AG071430 | NIH | None | None |