UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of usability of Newly developed medication assist device of tablet
Title of the study (Brief title)	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	Noriyuki Namiki
Organization	School of Pharmaceutical Sciences University of Shizuoka
Division name	Department of Pharmacy Practice and Science
Address	52-1, Yada, Surugaku, Shizuoka
TEL	054-264-5234
Email	uchidas@u-shiuoka-ken.ac.jp

Public contact
Name of contact person	Shinya UCHIDA
Organization	School of Pharmaceutical Sciences University of Shizuoka
Division name	Department of Pharmacy Practice and Science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000032086