UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038964 |
|---|---|
| Receipt number | R000044436 |
| Scientific Title | A randomized controlled trial of the effect on pharmacy students' learning of inhalation technique with the standardized instructions sheet versus pharmaceutical companies' instructions sheet |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2023/08/01 23:29:27 |
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Basic information
Public title
A randomized controlled trial of the effect on pharmacy students' learning of inhalation technique with the standardized instructions sheet versus pharmaceutical companies' instructions sheet
Acronym
A randomized controlled trial of the effect on pharmacy students' learning of inhalation technique with the standardized instructions sheet versus pharmaceutical companies' instructions sheet
Scientific Title
A randomized controlled trial of the effect on pharmacy students' learning of inhalation technique with the standardized instructions sheet versus pharmaceutical companies' instructions sheet
Scientific Title:Acronym
A randomized controlled trial of the effect on pharmacy students' learning of inhalation technique with the standardized instructions sheet versus pharmaceutical companies' instructions sheet
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of the standardized instructions sheet and pharmaceutical companies instructions sheet on learning inhalation technique of pharmacy students
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The score of inhalation technique test at 1 day after learning of inhalation technique with the instructions sheet
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Education with standardized instruction sheet for learning inhalation device technique (1 device)
Interventions/Control_2
Education with standardized instruction sheet for learning inhalation device technique (2 devices)
Interventions/Control_3
Education with Pharmaceutical company instruction sheet for learning inhalation technique (1 device)
Interventions/Control_4
Education with Pharmaceutical company instruction sheet for learning inhalation technique (2 devices)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
First to forth grade pharmacy students who agreed to participate in the study
Key exclusion criteria
Those who are using inhaler for their treatment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Emiri |
| Middle name | |
| Last name | Takahashi |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of pharmacy
Zip code
370-0033
Address
60, Nakaorui-machi, Takasaki, Gunma, Japan
TEL
027-352-1180
etaka@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Emiri |
| Middle name | |
| Last name | Takahashi |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Pharmacy
Zip code
370-0033
Address
60, Nakaorui-machi, Takasaki, Gunma, Japan
TEL
027-352-1180
Homepage URL
etaka@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Takasaki University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Takasaki University of Health and Welfare
Address
37-1, Nakaorui-machi, Takasaki, Gunma, Japan
Tel
027-352-1290
mune@takasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
38
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because I am writing a manuscript.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 23 | Day |
Last modified on
| 2023 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044436
