UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059463 |
|---|---|
| Receipt number | R000068010 |
| Scientific Title | Effectiveness of a Platform for Services Outside Long-Term Care Insurance in Reducing Burden Among Older Adults, Family Caregivers, and Care Managers |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/10/20 11:00:09 |
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Basic information
Public title
Effectiveness of a Platform for Services Outside Long-Term Care Insurance in Reducing Burden Among Older Adults, Family Caregivers, and Care Managers
Acronym
Burden Reduction via a Platform for Non-LTCI Services
Scientific Title
Effectiveness of a Platform for Services Outside Long-Term Care Insurance in Reducing Burden Among Older Adults, Family Caregivers, and Care Managers
Scientific Title:Acronym
Burden Reduction via a Platform for Non-LTCI Services
Region
| Japan |
Condition
Condition
Quality of life, Burden of caregiving
Classification by specialty
| Geriatrics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
With the increase in older people living at home, demand for non-long-term care insurance (LTCI) services including daily living assistance is rising. Meanwhile, care managers requested by older individuals to arrange non-LTCI services face increased burdens.
This study aims to verify the extent to which the physical and mental burden on older individuals, family carers, and care managers can be reduced by introducing appropriate providers to home-dwelling older people via an online platform involving multiple non-LTCI service providers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of life, Burden of caregiving
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Distributing a 10% service discount coupon
Interventions/Control_2
Distributing a 40% service discount coupon
Interventions/Control_3
Distributing a 70% service discount coupon
Interventions/Control_4
Distributing a 100% service discount coupon
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. Older individuals: Residents aged 65 or older living in Meguro Ward, Ota Ward, or Shibuya Ward, Tokyo
2. Family caregiver: If the older participant has a family member providing care, the primary caregiver
3. Care manager: If the older participant was referred by a care manager, that care manager
Key exclusion criteria
None.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koryu |
| Middle name | |
| Last name | Sato |
Organization
Keio University
Division name
Faculty of Policy Management
Zip code
252-0882
Address
5322 Endo, Fujisawa-shi, Kanagawa
TEL
+81-(0)466-49-3541
koryus@keio.jp
Public contact
Name of contact person
| 1st name | Koryu |
| Middle name | |
| Last name | Sato |
Organization
Keio University
Division name
Faculty of Policy Management
Zip code
252-0882
Address
5322 Endo, Fujisawa-shi, Kanagawa
TEL
+81-(0)466-49-3541
Homepage URL
koryus@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Watakyu Holdings Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SFC Research Ethics Committee
Address
5322 Endo, Fujisawa-shi, Kanagawa
Tel
+81-(0)466-49-3418
somu@sfc.keio.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 | 11 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 05 | 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
| 2025 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068010
