UMIN-CTR Clinical Trial

Basic information
Public title	A study about improvement of adhererance for the taking medicine :The evaluation of the support system about the taking medicine
Acronym	The evaluation of the support system about the taking medicine
Scientific Title	A study about improvement of adhererance for the taking medicine :The evaluation of the support system about the taking medicine
Scientific Title:Acronym	The evaluation of the support system about the taking medicine
Region	Japan

Condition
Condition	Psychiatric disease
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1:A evaluation of the effect for the support system which I made newly. 2:A evaluation of the effect for guidance of the taking medicine by pharmacist.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1:k-15 2:satisfaction of patient DAI-10
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	1:mental support. 2:Knowledge education about the taking medicine. 3:Action education about the taking medicine.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	A person who can understand purposet of the study, and answer to the questionnaire
Key exclusion criteria	A person except key inclusion criteria
Target sample size	340

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tomoko Kubota
Organization	Keio university hospital
Division name	nursing section
Zip code
Address	sinzyuku-ku sinanomachi 35
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Keio university hospital
Division name	nursing section
Zip code
Address
TEL	03-3353-1211(62222)
Homepage URL
Email

Sponsor
Institute	Keio university hospital
Institute
Department

Funding Source
Organization	nothing
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
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

Other administrative information
Date of disclosure of the study information	2010 Year 09 Month 01 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	Terminated
Date of protocol fixation	2010 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date	2010 Year 09 Month 01 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	2010 Year 08 Month 27 Day
Last modified on	2013 Year 02 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004949

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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