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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039349
Receipt No. R000044773
Scientific Title Nose study
Date of disclosure of the study information 2020/04/01
Last modified on 2021/02/05

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Basic information
Public title Nose study
Acronym Nose study
Scientific Title Nose study
Scientific Title:Acronym Nose study
Region
Japan

Condition
Condition Geriatric Syndrome, Cardiovascular diseases
Classification by specialty
Medicine in general Cardiology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of home BP measurement in preventing geriatric syndromes such as cognitive decline and non-communicable diseases
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Cognitive score 2, 5 years after the start of home blood pressure monitoring
Key secondary outcomes Geriatric syndrome, death, healthy life expectancy, cardio- vascular diseases, medical and nursing care costs

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 Home blood pressure measurement
Interventions/Control_2 Usual activity
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
40 years-old <=
Age-upper limit
110 years-old >=
Gender Male and Female
Key inclusion criteria Residents of Nose-cho, Toyono-gun, Osaka
Key exclusion criteria None
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name Kei
Middle name
Last name Kamide
Organization Osaka University Graduate School of Medicine
Division name Division of Health Science
Zip code 565-0871
Address 1-7 Yamadaoka Suita
TEL 06-6879-2551
Email kamide@sahs.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Mai
Middle name
Last name Kabayama
Organization Osaka University Graduate School of Medicine
Division name Division of Health Science
Zip code 565-0871
Address 1-7 Yamadaoka Suita
TEL 06-6879-2554
Homepage URL
Email kabayama@sahs.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization OMRON HEALTHCARE Co., Ltd.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical Center for Translational Research Osaka University Hospital
Address 2-2 Yamadaoka Suita
Tel 06-6210-8289
Email mirai@hp-mctr.med.osaka-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 04 Month 01 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
2020 Year 01 Month 31 Day
Date of IRB
2020 Year 05 Month 29 Day
Anticipated trial start date
2020 Year 06 Month 01 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

Management information
Registered date
2020 Year 01 Month 31 Day
Last modified on
2021 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044773

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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