UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059809 |
|---|---|
| Receipt number | R000068388 |
| Scientific Title | Feasibility of a Randomized Controlled Trial of Peer Support for Family Caregivers of Individuals with Dementia: Utilizing Voice Analysis for Emotion Estimation |
| Date of disclosure of the study information | 2025/11/18 |
| Last modified on | 2025/11/18 10:45:34 |
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Basic information
Public title
Feasibility of a Randomized Controlled Trial of Peer Support for Family Caregivers of Individuals with Dementia: Utilizing Voice Analysis for Emotion Estimation
Acronym
Feasibility of a Randomized Controlled Trial of Peer Support for Family Caregivers of Individuals with Dementia: Utilizing Voice Analysis for Emotion Estimation
Scientific Title
Feasibility of a Randomized Controlled Trial of Peer Support for Family Caregivers of Individuals with Dementia: Utilizing Voice Analysis for Emotion Estimation
Scientific Title:Acronym
Feasibility of a Randomized Controlled Trial of Peer Support for Family Caregivers of Individuals with Dementia: Utilizing Voice Analysis for Emotion Estimation
Region
| Japan |
Condition
Condition
healthy older adults (caregivers)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine whether a program that provides opportunities for interaction among family caregivers and promotes peer support - implemented in a clinical setting within brain and physical activation rehabilitation - can contribute to improving health-related quality of life (QOL) among family caregivers who experience physical and psychological burdens due to diagnosis and caregiving. By analyzing acoustic features and conversational characteristics of their interactions, we evaluate emotional states using voice analysis to assess the feasibility and potential impact of such a program.
Basic objectives2
Others
Basic objectives -Others
Nothing
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Emotion values extracted from the voice-analysis data during the discussion
(joy, neutral, anger, sadness, vitality/energy level)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants in the intervention group were gathered in a single room and engaged in a 40-minute session once a week for 4 weeks, following the sequence of: (i) presenting a task or issue, (ii) discussion focused on personal experiences, and (iii) mutual sharing and open discussion.
Interventions/Control_2
Participants in the control group engaged in oneonone conversations of the same duration with research assistants who had little knowledge of dementia care During these sessions the research assistants were instructed to listen attentively to everyday conversations and topics related to the participants caregiving experiences and to provide brief comments or feedback
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Family caregivers of patients with dementia who are participating in cognitive and physical activation rehabilitation (referred to as "Brain and Physical Activation Rehabilitation") at our outpatient center.
Key exclusion criteria
Participants with a medical history of painful physical conditions such as fractures, osteoarthritis, rheumatoid arthritis, postoperative pain, or cancer were excluded
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kamiya |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation
Zip code
474-8511
Address
7-430, Morioka, Obu, Aichi
TEL
0562-46-2311
mkamiya@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kamiya |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation
Zip code
474-8511
Address
7-430, Morioka, Obu, Aichi
TEL
0562-46-2311
Homepage URL
mkamiya@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
The Japan Health Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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, Obu, Aichi
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
| 2025 | Year | 11 | Month | 18 | 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
25
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
| 2025 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 18 | 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 | 11 | Month | 18 | Day |
Last modified on
| 2025 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068388
