UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040788 |
|---|---|
| Receipt number | R000046576 |
| Scientific Title | Feasibility study on art-appreciation and self-expression program for persons with mild cognitive impairment or dementia and their family caregivers: A pilot randomized controlled trial |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2023/06/26 14:47:33 |
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Basic information
Public title
Feasibility study on art-appreciation and self-expression program for persons with mild cognitive impairment or dementia and their family caregivers: A pilot randomized controlled trial
Acronym
Feasibility study on art-appreciation and self-expression program
Scientific Title
Feasibility study on art-appreciation and self-expression program for persons with mild cognitive impairment or dementia and their family caregivers: A pilot randomized controlled trial
Scientific Title:Acronym
Feasibility study on art-appreciation and self-expression program
Region
| Japan |
Condition
Condition
Mild cognitive impairment, dementia
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims at examining feasibility of a dyad, group-based art-appreciation and self-expression program for persons with dementia (PWD) and their family caregivers (CG).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in caregivers' depressive symptoms from the baseline to the six-week follow-up
Key secondary outcomes
PWD:
Cognitive function, depressive symptoms, anxiety, well-being, (instrumental) activities of daily living, apathy, loneliness, and satisfaction with PWD-CG relationship
CG:
Caregiver burden, anxiety, loneliness, self acceptance, and satisfaction with PWD-CG relationship
Feasibility assessment:
Attendance rate, satisfaction with each session, and intention to participate in the next session
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Art appreciation, collage production, and group discussion (six one-hour weekly sessions)
Interventions/Control_2
Usual care
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
| 60 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Persons clinically diagnosed as having mild cognitive impairment, mild dementia, or moderate dementia
-Those aged between 60 and 89 years old
-Those having provided a written consent form for this study
Key exclusion criteria
-Persons taking anti-depressants and/or anxiolytics
-Those having severe aphasia
-Those less likely to survive for a long-term period due to having progressive diseases (e.g., cancer)
-Those having severe visual and/or hearing impairments
-Those unable to understand the objective of this study due to having severe cognitive impairment
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Tami |
| Middle name | |
| Last name | Saito |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Social Science, Center for Gerontology and Social Science
Zip code
4748511
Address
7-430 Morioka-cho, Obu, Aichi 4748511, Japan
TEL
0562-46-2311
t-saito@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Tami |
| Middle name | |
| Last name | Saito |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Social Science, Center for Gerontology and Social Science
Zip code
4748511
Address
7-430 Morioka-cho, Obu, Aichi 4748511, Japan
TEL
0562-46-2311
Homepage URL
t-saito@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
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
National Center for Geriatrics and Gerontology
Address
7-430 Morioka-cho, Obu, Aichi 4748511, Japan
Tel
0562-46-2311
yaday@ncgg.go.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
| 2020 | Year | 07 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 14 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 24 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 18 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046576
