UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047593 |
|---|---|
| Receipt number | R000054172 |
| Scientific Title | Development and demonstration of a long-term care scheme aimed at preventing the severity of day service users |
| Date of disclosure of the study information | 2022/04/28 |
| Last modified on | 2025/04/28 14:35:24 |
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Basic information
Public title
Development of a care scheme using ICT to collaborate with care staff and the external professionals in a day service center
Acronym
Independence Support Project; IS Project
Scientific Title
Development and demonstration of a long-term care scheme aimed at preventing the severity of day service users
Scientific Title:Acronym
Development and demonstration of a long-term care scheme aimed at preventing the severity of day service users
Region
| Japan |
Condition
Condition
Elderly people who are certified as requiring support
Elderly people who are certified as requiring long-term care
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To verify that the care provided by professionals in remote assistance to day service center staff influences the daily life and psychosocial aspects of service users in comparison with the case without remote assistance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Goal attainment status of service users
Key secondary outcomes
Life Function Assessment
Barthel Index and difficulty questionnaire survey
Physical Function Assessment
Walking ability, agility, static balance, Dynamic balance, muscle strength
Mental health
WHO5, subjective wellbeing
Dementia-Related Assessments
Behavioral and Psychological Symptom of Dementia, Motivation, and initiative
Oral Function and Nutritional Status Assessment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Intervention Facilities
(1) Conducting service user evaluations
(2) Immediate feedback of evaluation results in paper form
(3) Providing support by professionals in interpreting results and providing feedback and advice to nursing staff regarding interventions and care of service users.
4) Practice of care based on 3)
Interventions/Control_2
Control facility
(1)Conducting evaluations of service users
(2)Immediate feedback of evaluation results in paper form
(3)Usual care practices
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
Elderly persons aged 65 years or older attending day services at the facility understudy
Key exclusion criteria
(1) Those known to be unable to conduct pre-, mid-, and post-evaluations
(2) Those who are participating or will be participating in other clinical trials
(3) Those who have difficulty communicating in Japanese
(4) Other persons deemed by the principal investigator to be ineligible as research participants.
(5) Persons who cannot give consent to participate in the research
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Shiba |
| Middle name | |
| Last name | Yoshitaka |
Organization
Fukushima Medical University
Division name
School of Health Sciences
Zip code
960-8031
Address
10-6 Sakaemachi, Fukushima City
TEL
024-581-5541
y-shiba@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Ueda |
| Middle name | |
| Last name | Takuya |
Organization
Tokyo metropolitan institute of gerontology
Division name
The Tokyo Metropolitan Support Center for Preventative Long-term and Frail Elderly Care
Zip code
173-0004
Address
Itabashi center Building 8 Floor,3-9-7 Itabasi, Itabasi-ku, Tokyo
TEL
03-5926-8236
Homepage URL
takuya@tmig.or.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo metropolitan institute of gerontology
Josai International University
Mejiro University
Kitasato University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University General Ethics Committee
Address
1 Hikarigaoka Fukushima City
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
| 2022 | Year | 04 | Month | 28 | 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
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 04 | Month | 26 | Day |
Last modified on
| 2025 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054172
