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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026053
Receipt No. 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

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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
Email 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/
Email yasumich@keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029502

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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