UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026053 |
|---|---|
| Receipt number | R000029502 |
| Scientific Title | The Kawasaki Aging and Wellbeing Project |
| Date of disclosure of the study information | 2017/02/24 |
| Last modified on | 2020/10/10 09:20:45 |
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Basic information
Public title
The Kawasaki Aging and Wellbeing Project
Acronym
KAWP
Scientific Title
The Kawasaki Aging and Wellbeing Project
Scientific Title:Acronym
KAWP
Region
| Japan |
Condition
Condition
Geriatric syndrome and frailty
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To observe a decline process of loss of independence in the very elderly person who are physically independent at baseline, and to identify the biological, genetic, and behavioral risk factors for physical and cognitive disability.
Basic objectives2
Others
Basic objectives -Others
We investigate to identify risk factors of declining physical and cognitive function to the necessity of nursing care in the very elderly person. We also investigated about risk factors for requiring nursing care in focus of life-style, social network and support, or medical cost.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary nursing care requirement authorization
Key secondary outcomes
All-cause mortality, decline of activities of daily living, and cognitive decline
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
| 85 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons who lived in the Kawasaki City, persons who aged 85 to 89 years old, and persons who did not receive nursing care in the daily life
Key exclusion criteria
Persons who aged less than 85 years or more than 90 years, persons who received certifications of needed long-term care or needed support (second level), persons who could not move by oneself to the place which performed survey, persons who could not understand the content of questionnaire, persons who could not perform conversation to the staff member, and persons who affected diseases in acute phase
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yasumichi |
| Middle name | |
| Last name | Arai |
Organization
Keio University School of Medicine
Division name
Center for Supercentenarian Medical Research
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5269-2468
yasumich@keio.jp
Public contact
Name of contact person
| 1st name | Yasumichi |
| Middle name | |
| Last name | Arai |
Organization
Keio University School of Medicine
Division name
Center for Supercentenarian Medical Research
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5269-2468
Homepage URL
http://www.keio-centenarian.com/
yasumich@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine, IRB
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
0333531211
med-rinri-jimu@adst.keio.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
慶應義塾大学医学部、川崎市立川崎病院、川崎市立井田病院、川崎市立多摩病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 01 | Month | 15 | Day |
Date trial data considered complete
| 2026 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
We performed interview including sociodemographic data, social network and support, well-being, medical history, activities of daily living, and eating habit assessed by brief-type self-administered diet history questionnaire (BDHQ). We also measured physical activity, cognitive function, mental health, sleep condition, physical examination, blood pressure and bone mineral density. Furthermore, we performed 12-leads electrocardiogram, body composition assessed by bioelectrical impedance analysis, carotid ultrasonography, nailfold capillaroscopy, blood test, urine test, and X-ray imaging of the spine.
Management information
Registered date
| 2017 | Year | 02 | Month | 08 | Day |
Last modified on
| 2020 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029502
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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