THE HCP ELIOT STUDY: Comparing Maintenance of Device Mastery With TURBOHALER© vs. SPIROMAX© in Healthcare Professionals naïve to Both Devices (The Easy Low Instruction Over Time [ELIOT] Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 516
- 主要终点
- Percentage of Participants Maintaining Correct Inhaler Technique for Spiromax Compared With Turbohaler 4 Weeks After Training as Assessed by Expert Assessor
研究概览
简要总结
This study is conducted to assess the ease of device mastery of a placebo SYMBICORT TURBOHALER vs a placebo Budesonide/Formoterol SPIROMAX device among healthcare professionals in-training (HCP).
详细描述
The purpose of this study is to identify how intuitive devices are to use and what level of training is required to ensure that HCPs are able to demonstrate the correct technique. The two devices examined will be the SYMBICORT TURBOHALER and placebo Budesonide/Formoterol SPIROMAX device among healthcare professionals (HCP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent is obtained and dated by the participant before conducting any study related procedures.
- •The participant is a student that is currently enrolled in the University where the study is conducted
- •The participant must be willing and able to comply with study restrictions and to remain at the study site for the required duration during the study period, and willing to return to the site for the follow up evaluation as specified in this protocol.
- •The participant has not previously used or received training in the use of either the SPIROMAX or the TURBOHALER in the last 6 months
排除标准
- •Participants will be excluded from participating in this study if they have asthma.
结局指标
主要结局
Percentage of Participants Maintaining Correct Inhaler Technique for Spiromax Compared With Turbohaler 4 Weeks After Training as Assessed by Expert Assessor
时间窗: 4 weeks
Examine if recall of device mastery is superior for the SPIROMAX inhaler as compared to the TURBOHALER after training to device mastery on both devices. The proportion of subjects achieving mastery of inhaler technique between the two inhaler devices was compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.
次要结局
- Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor(8 weeks)
- Number of Assessor-observed Errors Recalled at 4 Weeks After Baseline Visit by All Participants(4 weeks)
- Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants(8 weeks)
- Preference of Device Questionnaire 4 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score(4 weeks)
- Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process as Assessed by Expert Assessor(0 weeks (Visit 1))
- Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor(4 weeks)
- Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor(4 weeks)
- Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor(0 weeks (Visit 1))
- Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor(8 weeks)
- Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor(0 weeks (Visit 1))
- Number of Assessor-observed Errors Recalled During Baseline Visit by All Participants(0 weeks (Visit 1))
- Number of Assessor-observed Errors Recalled 8 Weeks After Baseline Visit by All Participants(8 weeks)
- Preference of Device Questionnaire 8 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score(8 weeks)
- Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process as Assessed by Expert Assessor(0 weeks (Visit 1))
- The Number of Levels Out of a 6 Level Training Process Required by Each Patient on Achieving Device Mastery as Assessed by Expert Assessor(4 weeks)
- Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants(0 weeks (Visit 1))
- Preference of Participant Device Questionnaire Assessed by PASAPQ Part II Q15 Score(0 weeks (Visit 1))
- Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor(8 weeks)
- Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants(4 weeks)