UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061486 |
|---|---|
| Receipt number | R000070295 |
| Scientific Title | A Cluster Randomized Controlled Trial of ICT-Based Remote Support for Long-Term Care Service Providers |
| Date of disclosure of the study information | 2026/05/30 |
| Last modified on | 2026/05/08 11:25:30 |
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Basic information
Public title
A Cluster Randomized Controlled Trial of ICT-Based Remote Support for Long-Term Care Service Providers
Acronym
A Controlled Trial of ICT-Based Remote Support for Long-Term Care Service Providers
Scientific Title
A Cluster Randomized Controlled Trial of ICT-Based Remote Support for Long-Term Care Service Providers
Scientific Title:Acronym
A Controlled Trial of ICT-Based Remote Support for Long-Term Care Service Providers
Region
| Japan |
Condition
Condition
NONE
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to provide remote support to staff at long-term care service facilities, including advice on practices to promote users independence and prevent functional decline, and to evaluate its effectiveness. Specifically, this study aims to clarify two aspects of the effectiveness of remote support provided by rehabilitation professionals: its effects on care staff's practices related to the prevention of functional decline and the promotion of independence among users, and its effects on the maintenance and improvement of users'daily functioning and psychosocial well-being.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Understanding of independence-supportive care and self-efficacy regarding the implementation of care aimed at promoting independence (original questionnaire)
Key secondary outcomes
users'activities of daily living ADL, physical function, and quality of life
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Educational intervention for day service staff
Interventions/Control_2
usual work
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Staff working at day care services who are involved in providing care to users
day services users
Key exclusion criteria
Staff employed at day care services but not involved in direct user care (e.g., cooks and drivers)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Shiba |
Organization
Fukushima Medical University
Division name
School of Health Sciences
Zip code
960-8516
Address
10-6 Sakaemachi, Fukushima City, Fukushima, Japan
TEL
024-581-5541
y-shiba@umin.ac.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Anzai |
Organization
Josai International University
Division name
Department of Physical Therapy
Zip code
283-8555
Address
1 Gumyo, Togane, Chiba, Japan
TEL
0475-53-2245
Homepage URL
anzai@jiu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
JSPT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Fukushima Medical University
Address
1 Hikarigaoka, Fukushima, Fukushima
Tel
024-547-1825
fmurec@fmu.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
| 2026 | Year | 05 | Month | 30 | 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
69
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
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 05 | Month | 08 | Day |
Last modified on
| 2026 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070295
