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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031723
Receipt No. R000031467
Scientific Title Original MethOd at pharmacy To ENhAnce Support for Health Improvement: a randomized trial
Date of disclosure of the study information 2018/03/14
Last modified on 2019/03/15

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Basic information
Public title Original MethOd at pharmacy To ENhAnce Support for Health Improvement: a randomized trial
Acronym OMOTENASHI trial
Scientific Title Original MethOd at pharmacy To ENhAnce Support for Health Improvement: a randomized trial
Scientific Title:Acronym OMOTENASHI trial
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effect of the "OMOTENASHI method" developed by the research representatives as an explanation method of the medicine to be used when pharmacists explain to foreign patients.
Basic objectives2 Others
Basic objectives -Others Investigate anxiety about facility staff's contact with foreign patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes When the pharmacist completes the explanation of the medicine, ask the foreign patient to understand the explanation of the medicine received from the pharmacist (self-made self-written questionnaire)
Key secondary outcomes When the pharmacist completes the explanation of the medicine, it asks the foreign patient to be satisfied with the explanation of the medicine received from the pharmacist (CSQ-8) / Before introducing the "OMOTENASHI method" to the facility to be studied, Ask anxiety about contacting staff with foreign patients (self-made self-written questionnaire)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Combine OMOTENASHI method with explanation of conventional medicine.
Interventions/Control_2 Explanation of conventional medicine.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria During the research period, foreigners who brought prescriptions issued from medical institutions in Japan to the facilities to be studied for the first time.
Key exclusion criteria When the visiting purpose for the facility to be studied is other than prescription dispensing.
In the case where the visit to the facility to be studied is second or later throughout the research period.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Ueshima
Organization Kyoto University Hospital, Institute for Advancement of Clinical and Translational Science (iACT)
Division name Department of EBM Research
Zip code 606-8507
Address 54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL 075-752-1513
Email ueshima.kenji.5m@kyoto-u.ac.jp

Public contact
Name of contact person
1st name Shota
Middle name
Last name Suzuki
Organization Kyoto University Hospital, Institute for Advancement of Clinical and Translational Science (iACT)
Division name Department of EBM Research
Zip code 606-8507
Address 54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL 075-752-1513
Homepage URL
Email omotenashi_2017@yahoo.co.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization None
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 Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committe
Address 54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
Tel 075-753-4680
Email ethcom@kuhp.kyoto-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 クラフト株式会社さくら薬局 京都駅前店 (京都府)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 14 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 No longer recruiting
Date of protocol fixation
2017 Year 08 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 14 Day
Last modified on
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031467

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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