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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040788
Receipt No. 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 2020/06/16

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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 YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
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
Email 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
Email t-saito@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

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
Email 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 Preinitiation
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 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
2020 Year 06 Month 16 Day
Last modified on
2020 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046576

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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