UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031148 |
|---|---|
| Receipt number | R000035577 |
| Scientific Title | Evaluation of the effect of medication adherence using Pletaal Assist System |
| Date of disclosure of the study information | 2018/02/10 |
| Last modified on | 2021/08/09 09:04:28 |
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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
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
koura@iwate-med.ac.jp
Sponsor or person
Institute
Iwate medical university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035577
