UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063048 |
|---|---|
| Receipt number | R000072172 |
| Scientific Title | The Effects of a Reminiscence Music Listening Program Intervention on Older Adults with Dementia Living at Home and Their Family Caregivers |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/24 22:34:54 |
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Basic information
Public title
The Effects of a Reminiscence Music Listening Program Intervention on Older Adults with Dementia Living at Home and Their Family Caregivers
Acronym
The Effects of a Reminiscence Music Listening Program Intervention on Older Adults with Dementia Living at Home and Their Family Caregivers
Scientific Title
The Effects of a Reminiscence Music Listening Program Intervention on Older Adults with Dementia Living at Home and Their Family Caregivers
Scientific Title:Acronym
The Effects of a Reminiscence Music Listening Program Intervention on Older Adults with Dementia Living at Home and Their Family Caregivers
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Neurology | Geriatrics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of an intervention using a reminiscence music appreciation program based on the musical preferences of older adults with dementia on the physical and psychological symptoms and social functioning of older adults with dementia living at home and their family caregivers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Depressive Symptoms in Older Adults with Dementia, the Caregiving Burden Faced by Family Caregivers
Key secondary outcomes
Mood States of Family Caregivers
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Music Listening Program
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Elderly individuals with dementia
1. Diagnosed with dementia
2. 65 years of age or older
3. CDR score of 0.5 or higher
4. Living with a family caregiver
Family caregivers
1. 18 years of age or older
2. Primary caregivers living at home with an elderly person with dementia
Key exclusion criteria
Elderly people with dementia
1. have a mental illness
2. have a hearing impairment (70 dB or more in both ears)
3. dislike music
4. have a habit of listening to music
Family caregivers
1. have cognitive impairment
2. have a mental illness
3. have a hearing impairment (70 dB or more in both ears)
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Aiko |
| Middle name | |
| Last name | Ito |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
10-2 Tomogaoka 7-chome Suma KOBE
TEL
078-796-4504
224k052@stu.ko-be-u.ac.jp
Public contact
Name of contact person
| 1st name | Aiko |
| Middle name | |
| Last name | Ito |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
10-2 Tomogaoka 7-chome Suma KOBE
TEL
078-796-4504
Homepage URL
224k052@stu.ko-be-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University
Address
10-2 Tomogaoka 7-chome Suma KOBE
Tel
078-796-4504
224k052@stu.ko-be-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
| 2026 | Year | 10 | 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
| 2026 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 24 | Day |
Last modified on
| 2026 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072172
