Clinical trial NCT02570425: Comparing Maintenance of Device Mastery With Turbohaler© vs. Spiromax© in Healthcare Professionals naïve to Both Devices
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Research in Real-Life Ltd
Sponsor class: NETWORK
Collaborators: name: Teva Branded Pharmaceutical Products R&D, Inc.
name: University of Sydney
name: Woolcock Institute of Medical Research
name: University of Technology, Sydney
name: The University of New South Wales
First posted: 2015-10-07
Enrollment: 516
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Participants will be excluded from participating in this study if they have asthma.

Primary outcomes:
measure: Percentage of Participants Maintaining Correct Inhaler Technique for Spiromax Compared With Turbohaler 4 Weeks After Training as Assessed by Expert Assessor
timeFrame: 4 weeks
Secondary outcomes:
measure: Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process as Assessed by Expert Assessor
timeFrame: 0 weeks (Visit 1)
measure: Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process as Assessed by Expert Assessor
timeFrame: 0 weeks (Visit 1)
measure: 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
timeFrame: 4 weeks
measure: 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
timeFrame: 4 weeks
measure: 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
timeFrame: 8 weeks
measure: 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
timeFrame: 8 weeks
measure: Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor
timeFrame: 0 weeks (Visit 1)
measure: Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor
timeFrame: 0 weeks (Visit 1)
measure: Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor
timeFrame: 8 weeks
measure: The Number of Levels Out of a 6 Level Training Process Required by Each Patient on Achieving Device Mastery as Assessed by Expert Assessor
timeFrame: 4 weeks
measure: Number of Assessor-observed Errors Recalled During Baseline Visit by All Participants
timeFrame: 0 weeks (Visit 1)
measure: Number of Assessor-observed Errors Recalled at 4 Weeks After Baseline Visit by All Participants
timeFrame: 4 weeks
measure: Number of Assessor-observed Errors Recalled 8 Weeks After Baseline Visit by All Participants
timeFrame: 8 weeks
measure: Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants
timeFrame: 0 weeks (Visit 1)
measure: Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants
timeFrame: 4 weeks
measure: Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants
timeFrame: 8 weeks
measure: Preference of Participant Device Questionnaire Assessed by PASAPQ Part II Q15 Score
timeFrame: 0 weeks (Visit 1)
measure: Preference of Device Questionnaire 4 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score
timeFrame: 4 weeks
measure: Preference of Device Questionnaire 8 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Sydney
name: Sinthia Bosnic-Anticevich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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