UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048660 |
|---|---|
| Receipt number | R000055447 |
| Scientific Title | Effects of interactive art appreciation in facilities for the elderly |
| Date of disclosure of the study information | 2022/08/13 |
| Last modified on | 2023/12/12 11:44:11 |
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Basic information
Public title
Effects of interactive art appreciation in facilities for the elderly
Acronym
Effects of interactive art appreciation in facilities for the elderly
Scientific Title
Effects of interactive art appreciation in facilities for the elderly
Scientific Title:Acronym
Effects of interactive art appreciation in facilities for the elderly
Region
| Japan |
Condition
Condition
people with dementia
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The psychological effect on elderly people of interactive art appreciation in facilities for the elderly was examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)The Scale of Experiencing with Regard to Arts Therapy Revised(SEAT-R)
Key secondary outcomes
(2)Two dimensional Mood Scale Short-Term(TDMS-ST) (3)WHO-QOL26 (4)GDS15 (5)NPI-NH Neuropsychiatric Inventory Nursing Home Version
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The following program was held for subjects over 6 weeks. Art appreciation meetings led by an art facilitator were provided: Paintings brought into the elderly facility were enjoyed once a week. Control:Rest time.
Interventions/Control_2
The following program was held for subjects over 6 weeks. Rest time. Control :Art appreciation meetings led by an art facilitator were provided: Paintings brought into the elderly facility were enjoyed once a week.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
People with mild cognitive impairment (MCI) to moderate cognitive impairment of CDR <=2, people who can hold a conversation, people who consented to the study.
Key exclusion criteria
Visual hallucinations, severe hearing loss, severe visual impairment, unstable physical condition.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Etsuko |
| Middle name | |
| Last name | Kawakubo |
Organization
Josai International University
Division name
Faculty of Nursing
Zip code
283-8555
Address
1 Gumyo,Togane-shi, Chiba
TEL
0475-55-7041
kawakubo@jiu.ac.jp
Public contact
Name of contact person
| 1st name | Etsuko |
| Middle name | |
| Last name | Kawakubo |
Organization
Josai International University
Division name
Faculty of Nursing
Zip code
283-8555
Address
1 Gumyo, Togane-Shi, Chiba
TEL
0475-55-7041
Homepage URL
kawakubo@jiu.ac.jp
Sponsor or person
Institute
Josai International University
Institute
Department
Personal name
Funding Source
Organization
Unimat Retirement Community Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gunma University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committees of Josai International University
Address
1 Gumyo,Togane-Shi, Chiba
Tel
0475-55-7832
reaerch-c@jiu.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
株式会社ユニマット リタイアメント・コミュニティの高齢者施設（シニアマンションおよび有料老人ホーム）計5か所
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 13 | 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 | 06 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 13 | Day |
Last modified on
| 2023 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055447
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
