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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041739
Receipt No. R000047509
Scientific Title Hypertension and prevention for dementia or frail in the aging society; the Karuizawa study.
Date of disclosure of the study information 2020/09/10
Last modified on 2020/09/11

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Basic information
Public title Hypertension and prevention for dementia or frail in the aging society; the Karuizawa study.
Acronym Hypertension and prevention for dementia or frail in the aging society; the Karuizawa study.
Scientific Title Hypertension and prevention for dementia or frail in the aging society; the Karuizawa study.
Scientific Title:Acronym Hypertension and prevention for dementia or frail in the aging society; the Karuizawa study.
Region
Japan

Condition
Condition General population of the elderly
Classification by specialty
Medicine in general Cardiology Neurology
Geriatrics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether the level of home blood pressure, especially that of nocturnal pressure, and the level of biomarkers related to the aging or lifestyle that could be a cause of hypertension is associated with the development of dementia or frail.
Basic objectives2 Others
Basic objectives -Others To detect the prevalence or incidence rate of dementia and frail in the general population of the elderly living in Karuizawa city.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Development of dementia, by measuring cognitive function using MMSE and MoCA-J, and consecutively by examination of specialist only for those of suspected dementia.
Key secondary outcomes 1) Development of frail
2) All-cause death
3) Development of depression
4) Development of hypertension
5) Development of cardiovascular disease
6) hospitalization

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
90 years-old >
Gender Male and Female
Key inclusion criteria 1) those who have a certificate of residence of the Karuizawa city.
2) those who have the national health insurance or the medical insurance for the elderly aged 75 or over.
3) those who already have visited for the specific health examination or the health checkup for older senior citizens, or who are planning to visit for those health examinations.
Key exclusion criteria 1) those who have already been diagnosed as dementia.
2) those who cannot express their intention to consent to participate in this study by themselves.
3) those who are not expected to be able to measure their home blood pressures or urine tests by themselves.
4) those who are judged to be unsuitable to participate in this study by the contact personnel.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Shotaro
Middle name
Last name Maruhashi
Organization Shinshu-University
Division name Reseach Center for Social Systems
Zip code 389-0111
Address Nagakura 5304-6, Karuizawa-machi, Kitasaku-gun, Nagano, Japan
TEL 0263-37-2310
Email shotaro@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Chie
Middle name
Last name Fujimaki
Organization Shinshu-University
Division name Reseach Center for Social Systems
Zip code 389-0111
Address Nagakura 5304-6, Karuizawa-machi, Kitasaku-gun, Nagano, Japan
TEL 0267-31-5360
Homepage URL
Email fujimaki_chie@gm.shinshu-u.ac.jp

Sponsor
Institute Shinshu-University
Institute
Department

Funding Source
Organization Karuizawa city
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor 1) Karuizawa city
2) TOYO Corporation Co., Ltd.
3) Shinshu university, faculty of engineering
4) Immuno-Biological Laboratories Co,Ltd.
Name of secondary funder(s) OMRON HEALTHCARE Co., Ltd.

IRB Contact (For public release)
Organization Shinshu-University
Address Asahi 3-1-1, Matsumoto, Nagano, Japan
Tel 0263-37-2572
Email mdrinri@shinshu-u.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

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 10 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 Preinitiation
Date of protocol fixation
2020 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 14 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information By identifying new predictive factors related to hypertension that are associated with developing dementia or frail during 5 years follow-up of participants, finding preventive measures of those diseases that are applicable to clinical practice is expected.

Management information
Registered date
2020 Year 09 Month 09 Day
Last modified on
2020 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047509

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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