UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056667 |
|---|---|
| Receipt number | R000064771 |
| Scientific Title | The long-term effects and related factors of short-term intensive care prevention projects |
| Date of disclosure of the study information | 2025/01/10 |
| Last modified on | 2025/01/08 18:43:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of the long-term effects and related factors of short-term intensive care prevention projects
Acronym
effects of short-term intensive care prevention projects
Scientific Title
The long-term effects and related factors of short-term intensive care prevention projects
Scientific Title:Acronym
effects of short-term intensive care prevention projects
Region
| Japan |
Condition
Condition
Older people living in the community who have been certified as requiring support for their daily lives.
Classification by specialty
| Rehabilitation medicine | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the long-term effects of short-term intensive care prevention projects by comparing changes in the level of care required, changes in long-term care insurance services, long-term care insurance benefit costs, and 10-year survival rates for elderly people living in the community who participated in short-term intensive care prevention projects with those of a control group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of new people requiring long-term care certification over the 10 years from 2015.
Key secondary outcomes
Changes in the level of care required, Long-term care insurance benefits, 10-year survival rate
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
Of the elderly living in the community who were assessed as requiring support in 2015 under the long-term care insurance system, those who participated in short-term intensive care prevention programmes and those who did not.
Key exclusion criteria
Persons with progressive neurological diseases and malignant tumours.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Takatori |
Organization
Kio University
Division name
Graduate School of Health Sciences
Zip code
6350832
Address
4-2-2 Mamichu, Koryo-cho, Kitakatsuragi-gun, Nara Prefecture
TEL
0745541601
k.takatori@kio.ac.jp
Public contact
Name of contact person
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Takatori |
Organization
Kio University
Division name
Graduate School of Health Sciences
Zip code
6350832
Address
4-2-2 Mamichu, Koryo-cho, Kitakatsuragi-gun, Nara Prefecture
TEL
0745541601
Homepage URL
k.takatori@kio.ac.jp
Sponsor or person
Institute
Other.
Institute
Department
Personal name
Funding Source
Organization
Self-procurement.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Kio University
Address
4-2-2 Mamichu, Koryo-cho, Kitakatsuragi-gun, Nara Prefecture
Tel
0745541601
k.takatori@kio.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
| 2025 | Year | 01 | 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
| 2024 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will observe the degree of certification for long-term care, changes in long-term care insurance services, total long-term care insurance benefit costs, and survival rates to date for 10 years in the backward direction for elderly people living in the community who participated in a short-term intensive long-term care prevention project in Nara Prefecture in 2015 (intervention group), and compare them with a control group. The control group will be people who have been matched with the intervention group in terms of basic characteristics (age, gender, level of care).
Management information
Registered date
| 2025 | Year | 01 | Month | 08 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064771
