UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031723 |
|---|---|
| Receipt number | 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 | 2021/07/08 15:04:40 |
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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
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
omotenashi_2017@yahoo.co.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Main results already published
Date of protocol fixation
| 2017 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 14 | Day |
Last modified on
| 2021 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031467
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
