Status: Planned
First registered on:
08/02/2016
Last updated on:
06/03/2017
1. Study identification
EU PAS Register NumberEUPAS12321
Official titleTraining requirements to master inhaler devices available in real-life clinical practice
Study title acronymTMID
Study typeObservational study
Brief description of the studyA prospective evaluation of time required and patient preferences when training patients with asthma and COPD to use inhaler devices as part of their routine care in the UK.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Department/Research groupResearch in Real Life Ltd
Organisation/affiliationOPRI Pte Ltd
Details of (Primary) lead investigator
Title Miss
Last name Wood
First name Lucy
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/10/201501/10/2015
Start date of data collection06/04/2016
Start date of data analysis08/06/2016
Date of interim report, if expected19/09/2016
Date of final study report19/12/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTeva Pharmaceutical Industries100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 116 Raffles Quay
Address line 2#33-03
Address line 3Hong Leong Building
CitySingapore
Postcode048581
CountrySingapore
Phone number (incl. country code)44-1223967582
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Price
First name David
Address line 116 Raffles Quay
Address line 2#33-03
Address line 3Hong Leong Building
CitySingapore
Postcode048581
CountrySingapore
Phone number (incl. country code)44-1223967582
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Asthma
Chronic obstructive pulmonary disease
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects204
Additional information
Minimum of 102 asthma patients, and 102 COPD patients in total.
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Prospective patient-based data collection
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Observational study
Primary scope : Observational study
12. Main objective(s)
What is the main objective of the study?
To measure the time needed and number of attempts for patients with asthma and COPD to master the required inhaler technique for a specific delivery device available as part of their normal care.
Are there primary outcomes?Yes
Time taken to achieve device mastery (as recorded in seconds from the beginning of training) and number of attempts to reach device mastery (please see full protocol for details).
Are there secondary outcomes?Yes
After training and assessment on the devices, the patient will complete an inhaler device preference questionnaire developed by OPC and administered by the HCPs and/or service coordinator on the day of the iHARP asthma/COPD review clinic (please see full protocol for details).
13. Study design
What is the design of the study?
Cross-sectional study
Cohort study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
Statistically significant results will be defined as p<0.05 and trends as 0.05≤p<0.10. Summary statistics will be produced for all baseline and outcome variables, as a complete dataset and by inhaler device. The mean/median time required to achieve device mastery will be compared by using Cox regression analysis. Log-rank tests will be carried out and p-values reported. The mean/median number of attempts required to achieve device mastery will be compared by using a paired t-test (means) or Wilcoxon signed rank test (medians), dependent on the data distribution. Results from the patient preference questionnaire will be compared using a paired t-test or wilcoxon signed rank test depending on the data distribution. The 5% level of significance will be used (two-tailed test).
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Available when the study ends
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
