UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the effect of medication adherence using Pletaal Assist System
Acronym	Evaluation of the effect of medication adherence using Pletaal Assist System
Scientific Title	Evaluation of the effect of medication adherence using Pletaal Assist System
Scientific Title:Acronym	Evaluation of the effect of medication adherence using Pletaal Assist System
Region	Japan

Condition
Condition	Ischemic stroke
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the effect of Pletaal assist system on medication adherence.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Compliance rate of medication while before, during, and after using Pletaal Assist System.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	Use of medication support system (Pletaal Assist System)
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	1) 20 years old and over 2) History of non-cardioembolic cerebral infarction, and cilostazol is orally administered for more than 3 months
Key exclusion criteria	1) Patients falling under the cilostazol contraindication 2) Patients who can not understand how to use the Pletaal Assist System due to cognitive dysfunction or brain dysfunction 3) Patients who can not recognize blinking of the lamp of the Pletaal Assist System due to visual disturbance 4) Patients who are incapable of self-management of internal medicine due to motor paralysis or ataxia 5) Other conditions which the physician deems inappropriate.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kazumasa Middle name Last name Oura
Organization	Iwate medical university
Division name	Department of Internal medicine, Division of Neurology and Gerontology
Zip code	020-8505
Address	19-1, Uchimaru, Morioka, Iwate
TEL	019-651-5111
Email	koura@iwate-med.ac.jp

Public contact
Name of contact person	1st name Kazumasa Middle name Last name Oura
Organization	Iwate medical university
Division name	Department of Internal medicine, Division of Neurology and Gerontology
Zip code	020-8505
Address	19-1, Uchimaru, Morioka, Iwate
TEL	019-651-5111
Homepage URL
Email	koura@iwate-med.ac.jp

Sponsor
Institute	Iwate medical university
Institute
Department

Funding Source
Organization	Iwate medical university
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Iwate Medical University
Address	19-1 Uchimaru, Morioka, Iwate, Japan
Tel	019-651-5111
Email	ikyomu@j.iwate-med.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	2018 Year 02 Month 10 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	Completed
Date of protocol fixation	2018 Year 01 Month 31 Day
Date of IRB	2018 Year 01 Month 24 Day
Anticipated trial start date	2018 Year 02 Month 14 Day
Last follow-up date	2021 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	2018 Year 02 Month 05 Day
Last modified on	2021 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035577