UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035132 |
|---|---|
| Receipt number | 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 | 2024/06/08 10:51:22 |
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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 | Ayumi |
| Middle name | |
| Last name | Kono |
Organization
Osaka City University, School of Nursing
Division name
Department of Home Health Nursing
Zip code
5450051
Address
1-5-17, Asahi, Osaka 545-0051
TEL
0666453540
ayukono-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Kono |
Organization
Osaka City University, School of Nursing
Division name
Department of Home Health Nursing
Zip code
5450051
Address
1-5-17, Asahi, Abeno,Osaka 545-0051
TEL
0666453540
Homepage URL
ayukono-tky@umin.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
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
School of Nursing, Osaka City University
Address
1-5-17 Asahi, Abeno, Osaka
Tel
+81666453540
ayukono-tky@umin.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
| 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
1658
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
Main results already published
Date of protocol fixation
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 01 | Day |
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
| 2024 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040040
