UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058421 |
|---|---|
| Receipt number | R000066784 |
| Scientific Title | A Randomized Controlled Trial of a Group-Based Psychosocial Support Program for People with Mild Cognitive Impairment or Dementia and Their Carers |
| Date of disclosure of the study information | 2025/07/10 |
| Last modified on | 2025/07/10 14:30:45 |
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Basic information
Public title
A Randomized Controlled Trial of a Psychosocial Support Program Using a Recreation-Based Approach with Music and Comedy for People with Mild Cognitive Impairment or Dementia and Their Carers
Acronym
REJOICE:Recreation-based psychosocial support using music and comedy
Scientific Title
A Randomized Controlled Trial of a Group-Based Psychosocial Support Program for People with Mild Cognitive Impairment or Dementia and Their Carers
Scientific Title:Acronym
GRASP Trial:Group-based psychosocial support program for people with MCI or dementia and their carers: A randomized controlled trial
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment, Dementia
Classification by specialty
| Neurology | Geriatrics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A randomized controlled trial will be conducted to evaluate the effectiveness of a psychosocial support program for individuals with mild cognitive impairment or dementia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Depression among family carers of people with mild cognitive impairment (MCI) and dementia
Key secondary outcomes
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 considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
1: Participants in the intervention program will consist of pairs of individuals with dementia and their family caregivers.
2: The program is a psychosocial support program composed of a hybrid team of professionals and non-professionals, delivered as a multi-component intervention consisting of six sessions: three music sessions and three comedy (manzai) sessions.
3: Each session will be held once every two weeks, lasting 120 minutes per session, for a total of six sessions over a 12-week period.
4: The program is based on reminiscence therapy, stress management theory, and a recreation-based approach that incorporates the elicitation of laughter.
5: Of the 120 minutes, a 40-minute separate session will be included. During this time, the individual with dementia will continue with the main joint session activities, while the family caregiver will participate in a group session where they (a) observe the individual's behavior during the session, (b) reflect and share their impressions, and (c) engage in discussion with care professionals to explore better caregiving approaches for persons with MCI or dementia. The session will also include peer interaction where caregivers can exchange concerns and support each other. The text used for this part is the caregiver support guide.
Interventions/Control_2
*Educational materials selected from the following sources will be adapted to align with the intervention sessions and distributed every two weeks at each intervention site: Introductory Textbook for People with Dementia and Their Family Caregivers and For Family Members Supporting a Person with Dementia both distributed at the Memory Clinic of the National Center for Geriatrics and Gerontology as well as handouts used in the control group of the Petit Salon psychosocial educational support program for individuals with mild cognitive impairment or dementia and their family caregivers.
*A total of six handouts will be distributed. For the first and sixth distributions, a follow-up phone call will be made a few days after the materials are handed out to confirm whether the recipients have read them. For the second through fifth distributions, at the time of handout delivery, participants will be asked to share their impressions of the previous material, and their responses will be used to assess whether the content was read, based on the level of consistency.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[Individuals with MCI or Dementia]
Eligible participants are those aged 65-90, living at home, with a clinical diagnosis of MCI or mild to moderate dementia (MMSE >= 15), and who consent to participate (either directly or via a legal representative). They must meet at least one of the following:
- Outpatient at the National Center for Geriatrics and Gerontology (NCGG)
- Completed caregiver education or "Petit Salon" at NCGG
- Applied via NCGG website or posters
- Applied via Kyoto City public notice
- Applied via Ritsumeikan University website
- Receiving support from dementia coordinators or care managers in Kyoto Prefecture
- Applied via Kusatsu City public notice
- Receiving support from coordinators or care managers in Kusatsu City
[Families]
- Aged 20-90, family caregiver of a person meeting the above criteria, able to attend all sessions with the individual, and has consented to join
- Main caregiver providing daily support, regardless of co-residence
Key exclusion criteria
[Individuals with MCI or Dementia]
*MMSE score of 14 or lower
*Individuals with severe aphasia
*Individuals with severe visual and auditory impairments
*Individuals with severe neurodegenerative diseases or psychiatric disorders who are deemed by their primary physician to be unsuitable for participation
*Individuals with progressive illnesses (e.g., cancer) for whom long-term survival is unlikely
*Individuals unable to understand the purpose of the study
*Individuals who cannot provide informed consent or whose legal representative cannot provide proxy consent
*Individuals currently residing in care facilities
*Individuals currently participating in any of the following programs at the National Center for Geriatrics and Gerontology:
(A) Cognitive and Physical Vitalization Rehabilitation Program
(B) Art Appreciation and Self-Expression Program
[Family Caregivers] - Exclusion Criteria
*Individuals working as medical or long-term care professionals
*Individuals with severe aphasia
*Individuals with severe visual and auditory impairments
*Individuals with severe neurodegenerative diseases or psychiatric disorders who are deemed by their primary physician to be unsuitable for participation
*Individuals with progressive illnesses (e.g., cancer) for whom long-term survival is unlikely
*Individuals unable to understand the purpose of the study
*Individuals currently participating in any of the following programs at the National Center for Geriatrics and Gerontology:
(A) Cognitive and Physical Vitalization Rehabilitation Program
(B) Art Appreciation and Self-Expression Program
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Seike |
Organization
National Center for Geriatrics and Gerontology
Division name
The Center for Comprehensive Care and Research on Memory Disorders
Zip code
474-0038
Address
7-430,Morioka-cho,Ohbu City, Aichi
TEL
0562-87-2500
ayahime@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Seike |
Organization
National Center for Geriatrics and Gerontology
Division name
The Center for Comprehensive Care and Research on Memory Disorders
Zip code
474-0038
Address
7-430,Morioka-cho,Ohbu City, Aichi
TEL
0562-87-2500
Homepage URL
ayahime@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Tecnology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ritsumeikan University
Name of secondary funder(s)
THE UEHIRO FOUNDATION ON ETHICS AND EDUCATION
IRB Contact (For public release)
Organization
Ethics and Conflict of Interest Committee of the National Center for Geriatrics and Gerontology
Address
7-430,Morioka-cho,Ohbu City, Aichi
Tel
0562-87-2500
hendo2@ncgg.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
BKC-LSMH-2022-082
Org. issuing International ID_1
Ritsumeikan University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 10 | 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
200
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
| 2022 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 10 | Day |
Last modified on
| 2025 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066784
