UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004115
Receipt number R000004949
Scientific Title A study about improvement of adhererance for the taking medicine :The evaluation of the support system about the taking medicine
Date of disclosure of the study information 2010/09/01
Last modified on 2013/02/28 12:25:43

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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 or person

Institute

Keio university hospital

Institute

Department

Personal name



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

Value
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