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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005524
Receipt No. R000006549
Scientific Title The study of developing new assessment tool about Comprehensive Geriatric Assessment (CGA) among elder hospitalized patients
Date of disclosure of the study information 2011/04/28
Last modified on 2013/12/11

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Basic information
Public title The study of developing new assessment tool about Comprehensive Geriatric Assessment (CGA) among elder hospitalized patients
Acronym The study of developing new assessment tool about Comprehensive Geriatric Assessment (CGA) among elder hospitalized patients
Scientific Title The study of developing new assessment tool about Comprehensive Geriatric Assessment (CGA) among elder hospitalized patients
Scientific Title:Acronym The study of developing new assessment tool about Comprehensive Geriatric Assessment (CGA) among elder hospitalized patients
Region
Japan

Condition
Condition Hospitalized cancer patients who are older than 64 years old
Classification by specialty
Medicine in general Psychosomatic Internal Medicine Geriatrics
Surgery in general Psychiatry
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine validity and reliability of the Japanese version of Vulnerable Elders Survey-13 (VES-13).
Basic objectives2 Others
Basic objectives -Others To examine validity and reliability of the Japanese version of Confusion Assessment Method(CAM) and the Japanese version of Nursing Delirium Screening Scale(DESC).
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The sensitivity and the specificity of the VES-13 compared with CGA as the golden standard.
The sensitivity and the specificity of the CAM and DESC compared with the diagnosis by DSM-IV as the golden standard.
Key secondary outcomes Correlation between CAM and DESC severity and total score of Memorial Delirium Assessment Scale (MDAS).

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Hospitalized patients in the National Cancer Center Hospital East
1)age of 65 years and older
2)ability to read and to write Japanese
3)submission of written informed consent
Key exclusion criteria 1)apparent consciusness disturbance
2)severe mental disorder
3)severe physical condition
4)being considered as not suitable to this study by the physician in charge
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Asao Ogawa
Organization The National Cancer Center Hospital East
Division name Psycho-Oncology Division
Zip code
Address 6-5-1Kashiwanoha, Kashiwa, Chiba 277-8577 JAPAN
TEL 04-7134-7013
Email asogawa@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Asao Ogawa
Organization The National Cancer Center Hospital East
Division name Psycho-Oncology Division
Zip code
Address 6-5-1Kashiwanoha, Kashiwa, Chiba 277-8577 JAPAN
TEL 04-7134-7013
Homepage URL
Email asogawa@east.ncc.go.jp

Sponsor
Institute The National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Grant for Cancer Reserch
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 国立がん研究センター東病院(千葉県)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 28 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 Enrolling by invitation
Date of protocol fixation
2011 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2013 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 181 patients were approched in person, 26 patients refused to participate, 155 patients consented to participate. 144 patients have finished investigation. Now midterm analysis.

Management information
Registered date
2011 Year 04 Month 28 Day
Last modified on
2013 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006549

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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