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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000038964
Receipt No. 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 2021/01/07

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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
Email 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
Email etaka@takasaki-u.ac.jp

Sponsor
Institute Takasaki University of Health and Welfare
Institute
Department

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
Email 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
Results
Results date posted
Results Delayed
Results Delay Reason
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 Suspended
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
2021 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044436

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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