Inhaler Trainer Efficacy Study: Interactive Training Tool Providing Technique Feedback for COPD/Asthma Medication Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Inhaler technique assessment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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):
- •Serevent®Diskus®(GSK), Salmeterol
- •Incruse Ellipta (GSK), Umeclidinium
- •Spiriva Handihaler (BIP),Tiotropium
- •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)
排除标准
- •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
研究组 & 干预措施
Inhaler Trainer Device
The Inhaler Trainer Device will monitor patients' inspiratory waveform to confirm technique compliance based on objective metrics and provide feedback on how to better perform technique. This intervention utilizes an instrumented training inhaler capable of accurately measuring the real-time inspiratory airflow achieved by the user when they perform their inhale maneuver. If a user's inspiratory flow fails to produce an inspiratory waveform with sufficient airflow parameters, the inhaler device may not optimally aerosolize the medication, and the delivered dosage to the lung will be negatively affected. The device measures the most important flow parameters in the users' real-time inspiration performance and translates them into an estimation of the dose delivered to the lung, based on detailed characterization of the user's inhaler product.
干预措施: Inhaler Trainer System (Device)
Inhaler Trainer Device
The Inhaler Trainer Device will monitor patients' inspiratory waveform to confirm technique compliance based on objective metrics and provide feedback on how to better perform technique. This intervention utilizes an instrumented training inhaler capable of accurately measuring the real-time inspiratory airflow achieved by the user when they perform their inhale maneuver. If a user's inspiratory flow fails to produce an inspiratory waveform with sufficient airflow parameters, the inhaler device may not optimally aerosolize the medication, and the delivered dosage to the lung will be negatively affected. The device measures the most important flow parameters in the users' real-time inspiration performance and translates them into an estimation of the dose delivered to the lung, based on detailed characterization of the user's inhaler product.
干预措施: Initial Inhaler Use Assessment (Other)
Inhaler Trainer Device
The Inhaler Trainer Device will monitor patients' inspiratory waveform to confirm technique compliance based on objective metrics and provide feedback on how to better perform technique. This intervention utilizes an instrumented training inhaler capable of accurately measuring the real-time inspiratory airflow achieved by the user when they perform their inhale maneuver. If a user's inspiratory flow fails to produce an inspiratory waveform with sufficient airflow parameters, the inhaler device may not optimally aerosolize the medication, and the delivered dosage to the lung will be negatively affected. The device measures the most important flow parameters in the users' real-time inspiration performance and translates them into an estimation of the dose delivered to the lung, based on detailed characterization of the user's inhaler product.
干预措施: Inhaler Use Instruction (Other)
Brief Interventions (BI)
During inpatient admission, participants randomized to the BI condition will receive the following: First, they will undergo an initial assessment of their respiratory inhaler technique using device-specific checklists. 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. The educator will not demonstrate the appropriate use of each inhaler to the patient, though the educator will be free to answer questions about appropriate use if posed by the study subject.
干预措施: Initial Inhaler Use Assessment (Other)
Brief Interventions (BI)
During inpatient admission, participants randomized to the BI condition will receive the following: First, they will undergo an initial assessment of their respiratory inhaler technique using device-specific checklists. 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. The educator will not demonstrate the appropriate use of each inhaler to the patient, though the educator will be free to answer questions about appropriate use if posed by the study subject.
干预措施: Inhaler Use Instruction (Other)
结局指标
主要结局
Inhaler technique assessment
时间窗: 6 weeks
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.
次要结局
- Usability(6 weeks)
- Spirometer pulmonary function measures(6 weeks)
- Disease control: Asthma(6 weeks)
- Spirometer pulmonary function measure: FVC(6 weeks)
- Estimated inhaled dosage(6 weeks)
- Spirometer pulmonary function measure: PEF(6 weeks)
- Disease control: COPD(6 weeks)
- Inhalation Parameters - flow slope(6 weeks)
- Inhalation Parameters - peak flow(6 weeks)
- Inhalation Parameters - total volume(6 weeks)
- Symptom Control: mMRC(6 weeks)
- Symptom Control: Modified Borg Dyspnea Scale(6 weeks)
- Symptom control: Asthma(6 weeks)