UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056330 |
|---|---|
| Receipt number | R000064197 |
| Scientific Title | Preliminary study on the effects of reminiscing with conversational AI on cognitive and psychological functions |
| Date of disclosure of the study information | 2024/12/02 |
| Last modified on | 2024/12/02 14:05:58 |
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Basic information
Public title
Preliminary study on the effects of reminiscing with AI on cognitive and psychological functions
Acronym
Effects of nostalgic conversation with AI
Scientific Title
Preliminary study on the effects of reminiscing with conversational AI on cognitive and psychological functions
Scientific Title:Acronym
Effects of reminiscing with conversational AI
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a preliminary study on the effects of the use of a conversational AI that can talk about memories on cognitive and psychological functions in healthy elderly subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-esteem before and after 12-week intervention
Key secondary outcomes
Rey Auditory Verbal Learning Test
Verbal Paired Associates I, II
Verbal fluency test
Frontal assessment battery
The World Health Organization-Five Well-Being Index
PGC Morale Scale
UCLA loneliness scale
Geriatric depression scale
Satisfaction With Life Scale
Lubbens social network scale
Profile of mood states2
Subjective happiness scale
Ikigai
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
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Conversations with the reminiscence AI app for 30 minutes each time, twice a week for 12 weeks
Interventions/Control_2
No intervention (Try to live a normal life)
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age 65 and over, 74 and under (at the time of registration)
Men and women
Have a smartphone or tablet (Android, iOS)
Able to engage in conversations using the reminiscence AI application for 30 minutes twice a week for 12 weeks (3 months) during the study period.
Have given their written consent to participate in the study.
Those who have agreed to the privacy policy of the reminiscence AI application.
Key exclusion criteria
Those who are unable to give informed consent
Those with a history or current history of dementia, mild cognitive impairment, or psychiatric disorders
Those who score 23 or below on the dementia screening test administered as a pre-test
Patients with hearing impairment
Those who are currently participating in other clinical research
Those who have other difficulties in conducting the research.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Tohoku University
Division name
Smart-Aging Research Center
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
TEL
022-717-8582
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Oba |
Organization
Tohoku University
Division name
Smart-Aging Research Center
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
TEL
022-717-8824
Homepage URL
kentaro.oba.c6@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Starley, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-728-4105
ec-med@grp.tohoku.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
| 2024 | Year | 12 | 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
| 2024 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 02 | Day |
Last modified on
| 2024 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064197
