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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028020
Receipt No. R000032086
Scientific Title Evaluation of usability of Newly developed medication assist device of tablet
Date of disclosure of the study information 2017/07/04
Last modified on 2018/01/03

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Basic information
Public title Evaluation of usability of Newly developed medication assist device of tablet
Acronym Usability of Newly developed medication assist device of tablet
Scientific Title Evaluation of usability of Newly developed medication assist device of tablet
Scientific Title:Acronym Usability of Newly developed medication assist device of tablet
Region
Japan

Condition
Condition None
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to evaluate the usability of a medication assist device in healty volunteers and erderly patients.
Basic objectives2 Others
Basic objectives -Others usability
Trial characteristics_1 Others
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Time to complete to put out the tablets from the device.
Key secondary outcomes Questionnaire survey for usability
Evaluation of usability observed by evaluators.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 Medication assist device of tablets
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy volunteers (20-40 y.o.) and elderly patients (>=65 y.o.)
Key exclusion criteria 1. Severely functional disorder in hand or fingers
2. Unable to communicate
3. Unable to obtain the consent to join this study
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyuki Namiki
Organization School of Pharmaceutical Sciences University of Shizuoka
Division name Department of Pharmacy Practice and Science
Zip code
Address 52-1, Yada, Surugaku, Shizuoka
TEL 054-264-5234
Email uchidas@u-shiuoka-ken.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinya UCHIDA
Organization School of Pharmaceutical Sciences University of Shizuoka
Division name Department of Pharmacy Practice and Science
Zip code
Address Department of Pharmacy Practice and Science
TEL 054-264-5234
Homepage URL
Email uchidas@u-shizuoka-ken.ac.jp

Sponsor
Institute University of Shizuoka, School of Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Otuka Pharmaceutical Co. Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 静岡県立大学(静岡県)、レモン薬局(静岡県)、やまうち薬局(静岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2017 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 30 Day
Last modified on
2018 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032086

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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