UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051576 |
|---|---|
| Receipt number | R000058845 |
| Scientific Title | Research on the making and development of a platform for living with dementia utilizing small-scale multifunctional in-home care |
| Date of disclosure of the study information | 2023/07/12 |
| Last modified on | 2025/01/10 09:27:17 |
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Basic information
Public title
Research on the making and development of a platform for living with dementia utilizing small-scale multifunctional in-home care
Acronym
Research on dementia platform using small-scale multifunctional in-home care
Scientific Title
Research on the making and development of a platform for living with dementia utilizing small-scale multifunctional in-home care
Scientific Title:Acronym
Research on dementia platform using small-scale multifunctional in-home care
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aiming to form and develop a "dementia living platform" that utilizes the characteristics of small-scale multifunctional facilities to revitalize the lives of older people with dementia and to promote understanding of people with dementia among community residents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Behaviors symptomatic of dementia in daily life during the past month
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Horticultural activities
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Older people with dementia: Older people aged 65 or older who are using a small-scale multifunctional facility, whose "level of independence in daily living for older people with dementia" is II or higher in the attending physician's opinion in the long-term care insurance certification screening, who are able to maintain a sitting position, and who have agreed to cooperate in the research.
Community residents: Residents over 50 years old who live in the area where the small-scale multifunctional facility is located, who are engaged in or willing to engage in volunteer activities in the community, or who have completed the dementia supporter training course, and who have agreed to cooperate in the research.
Key exclusion criteria
Older people with dementia: Those who have stopped using the small-scale multifunctional facility due to hospitalization or admission to a facility, or those who have offered to revoke their consent to cooperate in the research will be excluded from the study from that point onward.
Community residents: If a person is suspected of having dementia or mental or physical illness based on his/her participation, we will inform the person and provide support such as connecting the person to a medical institution so that appropriate measures can be taken promptly while respecting the person's wishes, and exclude the person from the volunteer program. In addition, those who have offered to revoke their consent for research cooperation will be excluded from the study from that point on.
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Sawa |
| Middle name | |
| Last name | Teraoka |
Organization
Kyushu University
Division name
Division of Nursing Science, Department of Health Sciences, Faculty of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi Higashi-ku Fukuoka, Japan
TEL
092-642-6939
teraoka.sawa.996@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Sawa |
| Middle name | |
| Last name | Teraoka |
Organization
Kyushu University
Division name
Division of Nursing Science, Department of Health Sciences, Faculty of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi Higashi-ku Fukuoka, Japan
TEL
092-642-6939
Homepage URL
teraoka.sawa.996@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
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
Kyushu University
Address
3-1-1 Maidashi Higashi-ku Fukuoka, Japan
Tel
092-642-6939
teraoka.sawa.996@m.kyushu-u.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
| 2023 | Year | 07 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2028 | 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
| 2023 | Year | 07 | Month | 11 | Day |
Last modified on
| 2025 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058845
