UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057492 |
|---|---|
| Receipt number | R000064106 |
| Scientific Title | The effect of test result feedback from psychologists on the QOL of elderly people with dementia and their families |
| Date of disclosure of the study information | 2025/04/02 |
| Last modified on | 2025/04/02 15:47:52 |
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Basic information
Public title
The effect of test result feedback from psychologists on the QOL of elderly people with dementia and their families
Acronym
FB study
Scientific Title
The effect of test result feedback from psychologists on the QOL of elderly people with dementia and their families
Scientific Title:Acronym
FB study
Region
| Japan |
Condition
Condition
Patient(Mild cognitive impairment, dementia), Family caregivers of patients
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect on the QOL of MCI and mild dementia patients and their family caregivers and the relationship with evaluation indexes related to personality traits by providing feedback on neuropsychological test results from psychologists to patients with MCI and mild dementia and their family caregivers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of QOL scores at 6 weeks between the early and waiting list groups
Key secondary outcomes
Compare the change in each QOL score from baseline to the 6 and 10 weeks between the early and waiting list groups
Compare with each QOL score between the early and waiting list and no preference groups
Examine the relationship between each QOL score and the scores of each item in the personality traits evaluation index in each group
Examine the relationship between the preference for feedback and the scores of each item in the personality traits evaluation index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Receiving feedback on neuropsychological test results from a psychologist
Interventions/Control_2
Waiting for feedback from a psychologist on the results of the neuropsychological test and receiving it later
Interventions/Control_3
Not wanting and not receiving feedback on neuropsychological test results from a psychologist
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Selection Criteria for patients:
1. Those who have taken neuropsychological tests (MMSE-J and RBMT) at the outpatient neuropsychiatry department of Osaka Metropolitan University Hospital between April 2025 and March 2028
2. Those who have already been notified by a doctor that they have mild cognitive impairment (MCI) or dementia
3. MMSE-J score is 20 to 30 points
4. Those who are 65 years of age or older at the time of obtaining consent
5. Those who are accompanied by a family caregiver
Selection criteria for family caregivers:
1. Spouse or second-degree relative living with a patient who meets the above selection criteria
2. Those who can answer the questionnaire
Key exclusion criteria
Exclusion criteria for patients:
1. Those who score 7 or higher on the GDS-15-J, which is the cutoff point indicating a tendency towards depression
Exclusion criteria for family caregivers:
1. Those who score 7 or higher on the GDS-15-J, which is the cutoff point indicating a tendency towards depression, if the age at the time of obtaining consent is 65 years or older
Those who score 40 or higher on the SDS, which is the cutoff point indicating a tendency towards depression, if the age at the time of obtaining consent is less than 65 years old
Target sample size
264
Research contact person
Name of lead principal investigator
| 1st name | Mai |
| Middle name | |
| Last name | Horimoto |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Neuropsychiatry
Zip code
545-8585
Address
1-4-3, Asahimachi, Abeno-ku, Osaka
TEL
06-6645-2121
mhorimoto@omu.ac.jp
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Horimoto |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Neuropsychiatry
Zip code
545-8585
Address
1-4-3, Asahimachi, Abeno-ku, Osaka
TEL
06-6645-2121
Homepage URL
mhorimoto@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan University
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
Ethical Committee of Osaka Metropolitan University Graduate School of Medicin
Address
1-2-7, Asahimachi, Abeno-ku, Osaka
Tel
06-6645-3456
gr-a-knky-ethics@omu.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
| 2025 | Year | 04 | Month | 02 | 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
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 09 | 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 | 04 | Month | 02 | Day |
Last modified on
| 2025 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064106
