UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005524 |
|---|---|
| Receipt number | 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 13:19:38 |
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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
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
asogawa@east.ncc.go.jp
Sponsor or person
Institute
The National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006549
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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