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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035132
Receipt No. R000040040
Scientific Title Trajectory of functional decline from care-need certification to death and health or long-term care utilization on ambulatory frail older adults in Minami Osaka
Date of disclosure of the study information 2018/12/12
Last modified on 2018/12/04

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Basic information
Public title Trajectory of functional decline from care-need certification to death and health or long-term care utilization on ambulatory frail older adults in Minami Osaka
Acronym The Southern Osaka Health and Aging Study
(SOHA)
Scientific Title Trajectory of functional decline from care-need certification to death and health or long-term care utilization on ambulatory frail older adults in Minami Osaka
Scientific Title:Acronym The Southern Osaka Health and Aging Study
(SOHA)
Region
Japan

Condition
Condition ambulatory frail older adults
Classification by specialty
Geriatrics Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To describe the trajectory of mortality or functional decline and health and long-term care utilization on ambulatory frail older adults
Basic objectives2 Others
Basic objectives -Others To clarify related factors with the mortality, functional decline, or health and long-term care utilization
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes mortality
Key secondary outcomes

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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Being newly certified as Support Level 1-2 in the Long-term Care Insurance program from 2012 April to 2013 March
2.Older adults aged 65 years and over
3.Residents in Izumi, Izumiotsu, or Misaki in Minami Osaka
Key exclusion criteria NA
Target sample size 1600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ayumi Kono
Organization Osaka City University, School of Nursing
Division name Department of Home Health Nursing
Zip code
Address 1-5-17, Asahi, Osaka 545-0051
TEL 06-6645-3540
Email ayukono-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayumi Kono
Organization Osaka City University, School of Nursing
Division name Department of Home Health Nursing
Zip code
Address 1-5-17, Asahi, Abeno,Osaka 545-0051
TEL 06-6645-3540
Homepage URL
Email ayukono-tky@umin.ac.jp

Sponsor
Institute Osaka City University
Institute
Department

Funding Source
Organization the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 12 Month 12 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
2017 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The study design is a 10-years cohort study from 2012 April to 2022 March, collecting the data of long-term care and health care insurance claims in 1600 frail older adults, newly certified as Support Level 1-2 from 2012 April to 2013 March, aged 65 years and over living in Minami Osaka.

Management information
Registered date
2018 Year 12 Month 04 Day
Last modified on
2018 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040040

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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