UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041739 |
|---|---|
| Receipt number | 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 | 2021/04/15 16:18:56 |
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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
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
fujimaki_chie@gm.shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu-University
Institute
Department
Personal name
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
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 07 | Day |
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
| 2021 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047509
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
